Follow the journey of Jen French, Cleveland FES Center research participant, in her “Stand by Me” journal. Jen participates in the Stand & Transfer Program for Spinal Cord Injury and will receive an upgraded FES system for trunk control and stand/transfer. This site will contain journal entries from Jen during her pre-surgical preparation, surgery, recovery and rehabilitation with intermittent comments from the clinical team clarifying Jen’s progress and experience. Although this site is hosted by the Cleveland FES Center, Jen’s Journal is her own. Jen’s journey begins…
Twelve years ago I sustained a spinal cord injury from a snowboarding accident. This accident left me a quadriplegic. To say the least, it was life changing. Eleven of those years post-injury, I have been using a stand and transfer neural prosthesis. This is an experimental device and I am the first woman to receive such a system. It consists of implanted electrodes to my paralyzed muscles and an external control device. Using this device on a daily basis has afforded me the ability to keep the paralyzed muscles healthy while combating medical complications common among people living with spinal cord injury such as pressure sores, spasticity and muscle atrophy. The FES system has given me alternatives to my wheelchair by enabling me to move around short distances with a walker. I have had unique experiences with the system which would be considered ‘impossible’ upon my initial diagnosis: the ability to stand at the seventh inning stretch, standing to hug a loved one and walking down the aisle at our wedding. I have integrated this technology into my daily life and have become accustom to its benefits.
It is now time for an upgrade. This is not as simple as upgrading your cell phone or computer. This is upgrading an implanted device. It will require hours of exercise, therapy and a lengthy surgical procedure. On August 30, 2010, a talented team at the Cleveland FES Center will implant the upgraded system. The surgery is expected to take seven hours with six weeks of recovery followed by rehabilitation and testing. The process should take about one year and this journal will chronicle the experience. In preparation for the surgery, in July I will begin a four hour daily exercise protocol. This again will be an experimental procedure in which several researchers will monitor my progress. This will be an exciting advancement in medical research for people living with spinal cord injury. Join me on this journey.
The Current Standing System
The questions have surfaced: Why a new system? What will the new system do? To answer these questions, let’s first establish the baseline. What is the system that I currently use?
The first generation of the Stand and Transfer system is really a hybrid system consisting of implanted components and external components. In the world of medical science, we have been implanting devices into humans for decades; like the heart pacemaker or the spinal cord stimulator. Additionally, external electrical stimulation has a long history of applications to the muscles. For spinal cord injury (and other forms of paralysis such as stroke or cerebral palsy) FES cycling uses electrodes placed on the surface of the skin activating muscles in a cycling motion. The Stand and Transfer system that I have has electrodes and a receiver that are surgically implanted and an external control unit and transmitting coil.
The system has eight channels; in this context one channel for each electrode (see the included diagram of the system). The implanted components include electrodes (intramuscular and epimysial) implanted deep into the muscle tissue. They were carefully placed by the research team mainly where the peripheral nerve innervates the muscle. These electrodes are placed in the quadriceps, hamstrings, gluteus maximus and the lower back. It is bilateral meaning there is a set for the right side of the body and the left. From each electrode extends a small, stretchy wire. These wires are tunneled through the fatty tissue up to the left hip area where they connect to the implanted receiver. This receiver is sutured to the tissue under the skin and connects to all the electrodes, like a hub. All of these pieces are fully implanted into the body. The external components consist of a coil which is taped to the skin over the receiver and an external control unit that is about the size of a small cable modem. The external control unit is the “brain” of the system. It holds the circuit boards and the power source for the system. When activated, the control unit sends messages via high radio frequency through the coil to the implanted receiver. The receiver decodes the message and sends signals to the electrodes activating the electrodes and stimulating the muscles to fulfill the given function. The current system has several functions from which the user may choose. Of course, it allows for activation of muscles to stand with a walker. It has other useful functions, as well. Leg lift exercises build the quads. “Extends all” activates all the muscles on for 10 seconds and off for 10 seconds for a patterned duration of an hour; building endurance fibers in the muscles and helping to reduce spasticity. The users of the system have suggested alternative functions not included in the original design. (Take note researchers: users have ideas of our own). Wanting more trunk control in our wheelchairs, there is now an option to activate the back and glut electrodes. An easy pressure release consists of a function to alternatively activate the gluts, hams and back electrodes. The system is dynamic yet simple. Personally, as a user, it has been integrated into my daily life and is an easy alternative to the wheelchair. This is the baseline from which we will build the coming upgrade.
Why the Upgrade
A member of the research team asked me, “Why do you want to go through with this?” The answer is not as easy as “because I want to.” There are several reasons to go through with the upgrade, some more practical than others.
The current system has eight channels. Currently, one electrode is turned off, the right hamstring. There is another electrode functioning at an extremely low level, the right glut. In essence, I am currently standing on six electrodes rather than eight. It has impacted my standing endurance; reducing the maximum stand time from 45 minutes to just 20 minutes. An average transfer takes less than 30 seconds, so it is still ‘functional’ but I have become accustom to using it for longer periods of time. Since I am lopsided on electrodes, standing puts strain on my right quadricep and my right knee tends to bend unexpectedly while standing. This requires me to keep both hands on the walker at all times and I no longer feel safe using single handed standing, to get objects out of reach for instance. For this reason, the system is not completely functioning to its original potential.
Age of the system is another consideration. Can you image using a cell phone that is eleven years old? I know many iPhone users who can’t handle one that is more than 18 months old. The implanted system is still safe and it is still ‘useable’ but there is this inherent desire to have the latest available technology if it can offer a better alternative. Marketers of consumer electronics are all too familiar with this human behavior. In this case, it is a little different. How long can I continue to use the current system? When it fails, do I go back to the KAFO (long leg plastic braces) I was using before the original implant? I’ve become almost addicted to the system; it is integrated into my daily life.
With spinal cord injury, many people focus on just the paralysis, the non-use of a limb, but there is more to it. As you learn in rehab there is also a daily management of or daily fight against secondary health complications like osteoporosis, pressure sores, joint contractures, urinary infections, spasticity, and poor blood circulation to name a few. Some of these can be silent killers or major life disruptions. Over the years, I’ve lost friends to some of these complications. There are alternative means to manage these secondary conditions and people living with spinal cord injury do. The point being that I manage using the implanted system. Without it, I would need to totally change how I fend off those common secondary complications.
Finally, what is my alternative? I made a choice many years ago to become actively involved with the advancement of science for spinal cord injury. I don’t have the mental capacity to be a scientific researcher or the training, for that matter. Taking stock in my current skills and training and how can it apply? When I was a college student working on my MBA, I was in the audience listening to the former CEO of Revlon. She had a theme that stuck with me; “If not me, who? If not now, when?” That guided me to being a clinical trial participant and knowing the many risks and responsibilities that accompany the role. What are the current alternatives for people with chronic spinal cord injury? Yes, people are paying thousands of dollars to go to countries such as China, India and Mexico to have stem cells implanted. Most recently, the FDA cleared Geron to continue a human clinical trial in the U.S. I’m too chicken to do that at this point and do not completely understand the mechanisms and potential results. There are some developments in gene therapies; but that is still in the early stages and not applied to humans yet. New rehabilitation techniques have emerged; but my injury is too chronic and complete that it does not apply to my case. To me, this is the best alternative.
Plus, as a childhood viewer of Lindsey Wagner in “The Bionic Woman”, it is pretty cool to experience it first hand.
Expanding from 8 to 24: The New System
Let’s go over the plans for the new system and account for the 24 channels.
First, we are keeping the old 8 channel system. It consists of 8 intramuscular and epimysial electrodes along with a receiver called an IRS-8. The previous posting listed the location of the electrodes which includes the quadriceps, hamstrings, gluteus maximus and erector spinae. The IRS-8 receiver is implanted in the front left hip lower abdominal area. We are keeping the old system for several reasons:
- It still works, so why toss out something that technically still works
- If we go in to change it, then we run the risk of damaging one or more components and
- My peace of mind. If all else fails, we can go back to the old system. This accounts for 8 of the 24 channels.
For the next 16 channels, we will be implanting an additional receiver, the IST-16, in the right front lower abdominal area. Yes, the name says it all; the device receives power and control information from outside the body and generates 16 channels of stimulation.. The newly implanted electrodes will connect to the IST-16 (I can hear the marketers out there cringing).
The new system will consist of two types of electrodes: cuff electrode and the intramuscular electrode. Just as it sounds, the cuff electrode is the shape of a spiral. In this spiral, there are four channels or individual electrical contacts. The cuff electrodes will be implanted on the left and right sides to control the group of muscles that created the quadriceps. Yes, I already have electrodes implanted in the quadriceps but those are epimysial. By implanted the cuff electrode we expect to selectively stimulate muscles within the quadriceps and potentially increase strength and endurance. Each cuff has 4 channels, making a total of 8 channels. On our count up to 24, we now have 16.
Now we have 8 more channels to cover. The remaining channels will be accounted by single channel intramuscular electrodes. They will be implanted as follows: 2 inner thigh, 3 gluteus, 2 lower back, 1 hamstring. Final calculations: 8 channels of intramuscular electrodes, 8 channels in the two cuff electrodes and the original 8 channel system. It all adds up to a 24 channel system. This will be the starting point for the surgical team since the plan may need to be adjusted in the operating room to get the best result.
Now it is on to preparations for a surgery less than 4 weeks away!
Getting a Baseline
It is research and that means testing is a big part of this entire project. A significant factor to move forward was the baseline testing during a visit to Cleveland in March 2010. The results from this testing was pivotal because it determined if I would be a candidate for the new system. Being 12 years post injury, anything could happen.
During this session, members of the research team and I tested several factors, including:
- The current system,
- The potential areas of implantation using surface stimulation, and
- Factors relating to trunk control.
The testing of the current system was performed to understand the thresholds of each muscle currently implanted with an electrode. We tested the strength of the muscles using manual muscle testing; commonly used by physical therapists to grade muscles on a scale of 0-5. The grade is done when the electrode is turned on and the therapist then tests the muscle. The thresholds are determined by testing the lowest setting when a muscle contraction begins and the maximum is the highest setting that is tolerated by the user; that would be me. All of this data is recorded to use as a baseline, a key point to statistically determine if there is improvement or not with the new system. For instance, the current system has two intramuscular electrodes implanted in the lower back area whereas the new system will add intramuscular electrodes near the same area. Here we can compare if there is improved trunk control with the additional electrodes.
To test the potential area of implantation, the team therapist used a stimulation probe to find the key points on the surface of the skin to gain the desired muscle contraction. For instance, the gluteus medius when contracted will push the leg out in a scissor motion. Using a probe, the optimum spot for a muscle contraction on the surface of the skin was located, marked and a surface electrode placed on that specific spot. Once each area was tested and located individually, we then combined to create a standing system. One of the engineers did some magic to program an external control unit to direct the surface electrodes and the implanted electrodes. Using this ‘prototype’ system, we used it to stand and get a sneak peak of what the new system will do and if my body would respond to it.
Finally, testing of trunk control which is an important potential functional gain. Trunk control or the lack of it is a difficult area to describe to those able-bodied folks. To understand the perspective of a wheelchair user by allowing a non-user to use a wheelchair for a day is relatively easy. To simulate lack of trunk control is more difficult. For those who participate in Yoga, Pilates or activities of that nature, you understand the importance ‘core muscles’ in your torso. For some people with spinal cord injuries, those core muscles are not functioning voluntarily. With this implanted system, there is an effort to restore function in those core muscles. To gather a baseline prior to surgery, we did some testing on the beloved Biodex machine. (You will be hearing a lot about this contraption.) Using the Biodex, we did several tests to gather data on the current function, strength and endurance of the trunk muscles. The image in this article is a photo of the testing.
Preparation for August 30th
They say good preparation leads to successful outcomes and quicker recovery. Some times we have the preconceived idea that just having a surgical procedure will fix a health issue. That knee replacement will help a person walk again or stomach bypass surgery will fix weight problems. In reality, it is not the surgical procedure alone. A component of a successful outcome is truly dictated by the attitude, behavior and participation for the recipient. Surgery is a component to help improve health, not the messiah. Weight management includes exercise, food intake and life style changes. The surgery to upgrade the implanted neuroprosthesis is no different. It will not be the answer to all issues related to spinal cord injury, but the expected outcome will help daily function and long term health.
Since mid July, I have been ‘laying low”. I’ve reduced activities to create time to prepare for the surgery on August 30. Preparation not only includes mental capacity, arranging to be on ‘limited activity’ post surgery but also exercise. The research protocol calls for exercise of the paralyzed muscles targeted to be implanted at least 30 days prior to surgery. Officially, on July 29, I began to comply with a 4 3/4 hour daily exercise protocol. I actually started exercising in mid-July. Starting early helped with the daily adjustment, especially since the first few weeks, I cheated and skipped several exercises. The extra few weeks of exercise helped me to adjust daily living activities to make sure I did not miss any of the exercises for the day.
So, what in the world am I exercising for that many hours? First targets are the muscles that already have electrodes implanted. Here are the exercises and durations using the implanted system:
- Leg lifts to exercise the quadriceps – 30 minutes
- Hips and Backs to exercise gluts, hamstrings and back muscles – 30 minutes
- Standing – 30 minutes
- Extends All which builds endurance fibers in all implanted muscles – 60 minutes
That is at total of 2 1/2 hours per day.
In addition, the research team issued a two-channel Neuromuscular Stimulator. The stimulator delivers electrical stimulation on two external electrode pads placed on the skin. Using this stimulator, I am required to exercise the following muscles that are targeted to receive implanted electrodes. The objective is to build the muscles to be prepared for implantation and responsive during surgery.
- Inner thigh muscles on both sides. The right side surface electrode favors emphasis toward the hamstring. The right hamstring has an implanted electrode that is turned off. – 45 minutes
- Gluteus Medius muscles = 45 minutes
- Right Gluteus Maximus. It has an implanted electrode that is weak. = 45 minutes (No picture is included. I didn’t want to moon the world)
That is a total of 2 1/4 hours of external stimulation.
That is 4 3/4 hours per day. All of this is recorded in an exercise log be given to the research team. Some of this is passive exercise. For instance, while I’m writing this, I am exercising my inner thigh and hamstrings. On the other hand, it is not practical to be running around town or sitting in an airport with external electrodes slapped to my skin…image getting through TSA! I’ve discovered that there are certain activities I can do while e-stimming like writing, reading or answering emails. But even little movements are not easy. The other day, I attempted to make copies while I was e-stimming. Every time the electrodes would turn on, I would get pushed back into my chair. Fitting in the exercise is an adjustment but it is very possible.
Aside from the stimulating paralyzed muscles, you really want to be in your best health before going into a long surgery (anticipated duration is 7 1/2 hours). I’m mentally preparing with relaxation techniques learned from our sailing team sports psychologist. Cardiovascular preparation by swimming 28-34 laps every three days. It is like getting yourself ready for that big competition or regatta. Every piece of the puzzled must fit. It is easy to get overwhelmed by all that needs to be done but with a daily/weekly plan, it is all possible to do my part, as a participant, to contribute to a good outcome.
Being a Conversant Participant
First, I would like to express my sincere gratitude to so many friends and family for your well wishes. I appreciate the cheering ‘rah rah’ gallery out there. Some of the responses have expressed that this must be ‘scary’.
Recently, I heard an interview with Dave Matthews, a musician I admire. He made this statement in a different context but it seems appropriate: “It is easy to fear what we don’t understand.” Over the past eleven years, I have been able to experience the implanted FES system first hand, follow and be educated on the technological developments over time. I will not pretend to understand all of the engineering and physiology behind the systems, but I understand enough to comprehend the impact. To that end, I am not fearful but excited for the upgrade; much like all those people who waited in line for the first iPad.
Being part of a clinical trial requires responsibilities on the part of the participant but also acceptance of risks. The ‘Informed Consent’ document sets the stage and clearly communicates the risks and responsibilities for taking part in a clinical trial.
I reviewed the main Informed Consent agreement. It is a mix of reading documentation for a mortgage and a life insurance policy, all rolled into one. As with mortgage documents (yes, I read ours) it clearly dictates the responsibilities as a participant in full disclosure; such as, what I am expected to do over the duration of the trial research, the time and financial commitments. It also covers the realistic expectation of potential outcomes. The ‘Risks’ section of the informed consent reflects like a life insurance policy. It covers many conceivable medical possibilities that can happen in the course of the clinical trial. Health risks and what to do if they occur are clearly covered.
A comfort area for me in all of this is knowing that there is an “easy out”. If I decide that I do not want this implanted system any more, it can be explanted. I run the risk of having scar tissue in the muscles and the skin, but for as far as we know, there will be no compromise to the integrity of my central nervous system.
In the end, it is nice to have plenty of time to review the Informed Consent and pose any questions to the research team prior to the surgery date. Upon reflection, this is when it really started to ‘sink in’. I also recently received a reminder from the airline regarding the ‘Upcoming flight with us’ and the therapist for the research team reminded me of the countdown to the surgery day. Do I really want to go through with this? Am I ready to take this on? Those questions entered back into my mind with the final outcome of ‘yes’.
It is time to hunker down, keep e-stimming and stick to the plan for preparation. When dock time comes, I’ll be more than ready.
Pre-op, in other words, more preparation for surgery. In previous postings, the baseline testing and exercise regimen were outlined to gather data and prepare the muscles to be implanted with electrodes. As we draw closer to the surgery date of August 30th, more traditional pre-op testing begins to surface.
Like so many things as a participant in a clinical trial, nothing is ordinary. This week I went for pre-op testing at a local hospital where I live in Florida. Since I’m a distant participant, my local doctor follows the progress and I use local medical facilities for some of the preparation. The research team sent me a letter listing the tests needed. It included some typical stuff like blood
tests, urine analysis and chest x-ray, but it also included additional testing like x-rays of the pelvis, knees and ankles. It’s always entertaining to watch the radiology technicians’ eyes widen as they see all the hardware in my abdomen from the current system. The experience was actually pleasant. I haven’t been in a hospital for a long while. It was refreshing to be treated as a customer rather than a refugee waiting for rationings.
In addition to the lab tests and x-rays, I had doctor’s orders to go sailing. Ok, let me explain. As a member of the US Sailing Team Alphagraphics (team website www.j2racing.org) we spend a lot of time on the water practicing and competing. With this in mind, a concern surfaced about how my body interacts with the boat and adaptive seating system. The research team wanted to understand the pressure points around the hips and thigh areas. With those orders and a Sharpie in hand, we proceeded to the sailing center and hopped in the boat. We marked the edge of the seat on my skin and took photos. We then went sailing and did several common maneuvers on the water and took video of this. The evidence was sent to the research team in Cleveland, to help develop the final surgical plan. So there you have it, I had doctor’s orders to go sailing. I am liking this project more and more.
After passing these tests, the research team gave the approval to proceed in the final days prior to surgery. Traveling up from Tampa Bay to Cleveland gave me time to reflect on the days passed and those to come. At this point, the hours of exercise will pay off and I just start to focus on keeping a strong immune system and minimizing risky activities (which is difficult for me to do). The Friday prior to surgery, we met with the surgical team, which also includes the engineers and therapist. This session was to map out the final surgical plan on the skin with a marker and discussion of the procedures for the surgery. Sunday evening, I will be admitted to the research unit at MetroHealth Medical Center and, yes, more tests. On Monday, August 30th, we will begin the 8 hour surgery for implanting the system. I will be under anesthesia the entire time and will be overcoming the hangover for a few days afterwards. If all goes well, I’ll be on a plane back to Florida on September 3rd.
This is when all the preparation, the hours of e-stimming the muscles and detailed planning come together in this significant milestone. There will be much more work and testing afterwards. Good outcomes here will guide the performance in the future.
Jen is in surgical recovery, this posting is provided by the research therapist…After eight hours, countless pacing time and lots of concentration, Jen 2.0 has emerged from the operating room at MetroHealth Medical Center. Starting at 0630, Jen was wheeled out of the research unit of the medical center and down into the surgical area for final preparations. There was a bit of chatter while members of the research team poked in to check on their soon-to-be latest technological creation. Then the anesthesiologist goes to work.
After the knockout, the surgical team consisting of three surgeons, two anesthesiologists, six engineers, a very nervous principal investigator (el captain) and me, the therapist, who all go to work like an eloquent ballet. We have been over the routines, plans and procedures many times before this point. This is the début performance.
During the procedure, the ten electrodes are carefully placed in the planned muscle points. For each placement, approval by the engineer and me is required before the surgeons suture the electrode into the final spot. We began on the backside of the body then turned Jen over to complete the system. After placement, the wires for the electrodes are tunneled through the fatty tissue to connector points. From the connector points, the wires weave their way to plug into the implanted receiver. (And you thought the back of your entertainment system looked complicated).
Patiently in the waiting room is Jen’s mom as command central. Throughout the surgery, I would emerge (or call) to deliver an update to mom. She would then communicate this out. Occasionally, the principal investigator would emerge for more pacing of the floor. After eight hours, the team rolls Jen out of the production room. The job is done successfully. Now it is time for the team to rest and for Jen to slowly get rid of the hangover.
“It’s not easy being green.”
Kermit the frog was top of our minds as I was released from the surgical recovery room and moved to the clinical research unit of the hospital. Looking down on my legs, they were green. The antiseptic wash used for surgery prep turns the skin this green color, it can also protect from infection. With a little anesthesia still in my system, singing Kermit the frog songs seemed appropriate.
The surgical team exited the long day happy with the outcomes. Maybe the word is ‘excited’. There seems to be a buzz around here; knowing you are on the verge of something good.
We had to set the team off to a positive start on surgery day. As the person on the table, I took responsibility for setting the tone (with some help from my sister). On the Friday prior to surgery, they marked on my skin the areas for implant using a skin marker. Then, they sent me home (to my sister’s house) for the weekend with a skin marker. ‘Just in case any of the marker started to wash off.’ I smell an opportunity, plus they should know better. Starting off the day on the surgical table, we had a message on my bottom to the research team and smiley face on my belly button. Providing some comic relief for a long day of surgery.
Apparently the cocktail used to knock me out, aka margarita on the rocks with salt, was not so bad. The transition from knockout to wakeup was smooth. Amazing, particularly since we planned to have me out with a hangover for at least 24 hours. Post surgery, I was awake pretty quickly and yappy as ever on the move from the recovery room to the clinical research unit (CRU). This is the nursing unit where I spent the next five days getting back to ‘normal.’
If there is any place to be after a long surgery, it is the CRU. My favorite nurses are here. Most were here when I had my first implant in 1999; some retired and came back. Coming here was a bit of a reunion. This nursing unit focuses on research. The team is extremely skilled, they deliver comfort when you need it, and make you laugh when you are in pain. Of course, homemade cookies from mom doesn’t hurt either. (Although the residents ate most of those.)
Otherwise, recovery is very similar to that from any big surgical procedure.
- Progress from Jell-O and soup to solid foods (well hospital food)
- Vitals (blood pressure, temp, pulse) and rolling every two hours
- Breathing exercises to restore lung capacity
- Visits from residents at 3am
- Shedding of needles and IV tubes
- Then there is the glue man.
They used sutures and skin glue to close all the incisions from surgery. The glue, much like super glue (but don’t try this at home) seals the wound to help protect from infections. A resident came in afterwards with glue stick in hand to re-seal all the incisions. Just like super glue, it can’t touch anything until it dries otherwise, I may be glued to the bed!
Days are moving fast. Day 3 was the first time back in my chair. Within about 10 minutes I said, “Let’s go for a walk”. The hospital room gets small after a few days. Now is the time to transition home and understand the restrictions for activity. We will take x-rays of the system within the body. Testing will be done with a scope to make sure the system is intact.
The cheering sections on Facebook, Plaxo, Linkedin and just plain email have been so comforting. They have made this process much easier. I am very gracious to have you all out there. Now, I’m back to my green body and transitioning home.
“Some day you’ll find it, the rainbow connection. The lovers, the dreamers and me.”
Comforts of Home
One of my friends posted “home is where the healing process begins” and there is a lot of truth to that!
Although sometimes I think that hospitals deliberately try to make some amenities miserable just so we are encouraged to ‘go home’. Take for instance food. After surgery, it is common to transition to a liquid diet consisting of Jell-o, chicken broth, etc. But I was sent chicken broth for every day there after…high sodium chicken broth. This is when family comes to the rescue. After my sister got a whiff of a salmon patty that looked like some mystery meat you get at a fast food joint and smelled like the dumpster out back, she brought me lunch the next day. Vegetables, beloved fresh vegetables never tasted so good. Vegetables, not over cooked or smothered in unknown white sauce, dominated the most I ate in one meal while in the hospital. And on top of that she brought fruit, not from a can or stagnant in corn syrup, it was fresh fruit. My mom followed suit the next day. Then my first day home, friends brought over a homemade quiche. Those were my first tastes of the comforts of home.
On the trip back to Florida, I was accompanied by my mom and it was pretty uneventful with a few lesson learned.
- Don’t forget your discharge papers. I was so excited to get home that I completely forgot to do the proper procedures for discharge. Thank god for cell phones, fax machines and email.
- Be straightforward with TSA. Going thru airport security is never easy for people with disabilities. I had notes on letterhead from every organization involved in this research project with one in particular explaining the do’s and don’t for post surgery recovery. As TSA pulled me aside, I handed them the letters straight away, then worked together to get thru the process. And finally,
- Take the pain meds before getting on the flight. I’m not a person who takes pain medication. Not because I’m a ‘tough guy’ but I hate how they make me feel and cloud my thinking. Again, excited to go home, I forgot to take the hospital issued Tylenol. In my pocket book I only had one Tylenol, which wore off half way down to Florida. By the time we departed the aircraft, I was in pain and very punchy. My mom has the patience of a saint and I was lucky she didn’t smack me up-side-the-head.
We made it back. To minimize transfers, we arranged the van for wheelchair tie-downs and my mom drove us from the airport to our home.
The biggest comfort of home came that evening in the form of a full night sleep without interruptions at wee hours of the morning and in my own bed. Ahhh!!! The comforts of home!
Adjusting to Home
Ok. So maybe home isn’t so comfy? Have you ever entered your home and it just seems different? Maybe you came home after a long vacation or after losing a loved one; for that matter you came home after being in the hospital for several days or weeks. It is not that your home changed. The fact of the matter is you changed. You are looking at familiar surroundings through different eyes. This feeling is captured so well in the movie ‘Murderball’. (If you haven’t seen it and you live or work with people living with spinal cord injury, it is a movie worth watching.) In the movie there is a scene when a man, new to living with a spinal cord injury, goes home from the rehabilitation hospital for the first time. You can see it in his eyes. He has changed but his home has not.
The good thing is we have a cunning ability to adapt. We take on this adaptation without even thinking about it. Along with the welcoming comforts of home after returning from Cleveland, I had to adapt to the new restrictions in my familiar home. Understand that I live in a fairly wheelchair accessible home (with the exception of our kitchen which has not been adapted yet). There is an adjustment period to my surroundings given the ‘Home –Going Instructions’ from the research team.
For the next 5 1/2 weeks, I am on ‘restricted activity’. This means:
- Only 4 “round trip” transfers per day
- No strenuous activity
- No bending at the hip more than 90 degrees
- No bending forward in the wheelchair, using reachers to retrieve items on the floor
That doesn’t seem like much, but think about it. Two transfers are taken up each day for getting in and out of bed. A reacher is needed every time I drop something on the floor. Many daily activities require bending, like feeding the cats, putting on shoes, filling the dishwasher, etc. I’m not complaining but just pointing out the adjustments needed that you don’t realize until you are in the situation.
As a result, I’ve adapted the ‘different’ to feel familiar again. Thanks to the help of my mom and Tim, this adjustment has been easier. Those old reachers are strategically placed in every room of the house. Items used on a daily basis have migrated from low storage to higher. I am more careful not to drop anything on the floor. Transfers in and out of the wheelchair are planned for every day and it becomes a game of ‘trade-offs’. Driving is out of the question; taking up two transfers straight away.
Choosing days to shower is an adjustment. Speaking of bathing, any cruiser out there knows that freshwater showers can be a luxury. I’ve had my time on long trips aboard a cruising sailboat, coming ashore after several days and taking that long awaited hot shower. After more than a week and with some green tint still lingering on my skin, I had my first shower post surgery.
Now, that is a feeling all too familiar.
“2, 4, 6, 8, 9….ok we need to find 6 more.” Words spoken from my local physician, as he shook his head like a speechless parent discovering his child just got a tattoo. This week I met with my local physician to observe the progress of the incisions as they are healing. I think he was in a little disbelief by seeing so many incisions, but when I started to tell him of potential functional gains like trunk control and standing stability, he understood the ‘pay off.’
Fifteen is the total count of incisions from the surgery. There are 10 incisions for each electrode, one for the implanted receiver and four for the connector sites. Connector sites are a ‘pass thru’ for the wires routed to the implanted receiver. The incisions are closed with internal sutures and skin glue externally. The skin glue is starting to peel off and expose the scars resulting from the surgery. Each time one is exposed, it gets a daily treatment of vitamin E. As it turns out the fabulous fifteen are healing well.
But I have to admit, I look down at my abdomen and wonder. It is hard to believe twelve years ago when I was first injured; one scar was such a concern. At the time, I did everything I could to conceal that one scar on the back of my neck. That one scar was the result of the vertebrae fusion surgery after my accident. I wore collared shirts, neck scarves with blouses and countless turtlenecks just to conceal that one scar. Now, I have 13 scars from the first implanted system and 15 from the most recent upgrade; for a total of 28. But those 28 are mostly concealed by everyday clothing. Unless I wear a bikini (and I don’t plan to do so any time soon), the scars are not even noticeable and are mostly hidden.
I’ve become acutely aware of the ‘image’ industry filled with plastic surgeons, tattoo artists, anti-aging creams and scar reduction potions. As it turns out advice from a knowledgeable researcher in the area of wound healing, good old vitamin E or retinol do the job to aid in the healing of the skin. My 28 scars tell a story. Who needs tattoos; these scars are my body art.
Missing the System
It has been over four weeks since the surgery to implant the upgraded system. More apparent, it has been over four weeks since I last used the old implanted system. It has been that long since I last stood out of my wheelchair, used back electrodes for trunk control or exercised the endurance fibers in the implanted muscles.
Ok, I can adjust to not being able to stand for a few months. That adjustment is easy because in the back of my mind, it is a short term sacrifice for a long term gain. Not being able to stand or use the trunk control features results to some daily living inconveniences. The adjustment has an eerie reflection of what I experienced when I was first introduced to life as a wheelchair user. In the end, the inconvenient sacrifices are not as traumatic knowing that in the near future I will have the capability back and hopefully with more function.
The ‘real’ noticeable change is physiological; those changes that are not obvious but creep into your daily life and have a significant impact. My internal systems are not performing as they usually do. Things like urinary and fecal tracks, digestion and circulation have all changed. As a person with an incomplete spinal cord injury who has motor paralysis but retained sensation, my rear end and back are sore from sitting in the wheelchair for most of the day. Not being able to exercise those muscles, the ongoing threat of a pressure sore lingers in the back of my mind. The biggest change, however, is the increased spasticity.
Spasticity is common among people living with central nervous system disorders. It is described as an ongoing level or sudden burst of contraction of a muscle, with decreased ability to volitionally control the muscle contraction, and increased resistance felt on passive stretch. Contractions can be so strong that people experience extreme rigidity or get tossed out of a wheelchair. There are many ways to manage this condition. The most common in the U.S. is a pharmaceutical solution.
When I was first injured, I tried that solution. Just like pain medications, I could not function productively while using a drug that has a base as a muscle relaxer. Over the years, I have used stretching and electrical stimulation to keep the condition under control. While in this recovery stage, stretching of my lower extremities is restricted and use of surface electrical stimulation is permitted only below the knee. This helps but is still not sufficient to keep spasticity from rearing its ugly head.
At this point, psychologically and functionally, I can adjust for the short term without using the system. With less than two weeks to go until the ‘limited activity’ stage is behind me, the return to being active and the time to initially turn on the new system is in sight. But more significantly in the short term, my body misses the system.
One More Week
One more week to go of restricted activity. At this point, my incisions are healed, the skin glue is off and I am exercising with light arm weights. Now, I’m restless to start being active again.
In one more week, we will also turn on the system for the first time since the surgery. When the research team implanted the electrodes on August 30th, for each electrode they would place it in the muscle tissue, and then turn on the stimulation to test the contraction of the muscle against the placement of the electrode. When they found the optimal contraction, the surgeons secured the electrode in place and left the electrode to rest and the tissue to grow around it.
When we turn on the system next week that does not mean I will be standing out of my wheelchair. If any researcher told me that after 6 weeks of sedentary recovery, I will be standing and moving around instantly then that same person is probably selling snake oil too.
Next week, I will meet with members of the research team in the laboratory at MetroHealth Medical Center. We will spend several hours testing each electrode individually, a process called profiling. Then the therapist will issue an exercise regime for the next eight weeks. The regime is designed to slowly build the muscle fibers (both strength and endurance fibers) using the implanted electrodes. Just as body builders slowly add weights to the barbells and as marathon runners slowly add miles to their running routine, I will be slowly increasing weights and repetitions for each muscle group. There is no instant gratification. Just as I learned in rehab after my initial injury, recovery is a slow process. Instead of focusing on daily progress, it is more productive to focus on the long term goal.
In the meantime, I have one more week with these limitations. As I’m looking forward to turning on the new system, Tim and I will celebrate our anniversary. We will be remembering a magical day when we committed our wedding vows while I was using the original system.
Flipping the Switch
After months of anticipation, this past week we flipped the switch on the new system. But it is not as easy as flipping a switch to turn on a light. Oh no. It is much more involved and complex, plus add in the complexity of the human body…and you have hours of tweaking.
I traveled up to Cleveland last Wednesday with lab time scheduled for Thursday and Friday. Filled with excitement, it was hard to contain. Sleeping that night was difficult; like a kid on Christmas Eve waiting for St. Nick to arrive. I resorted to the relaxation techniques taught by the sailing team’s sports psychologist. Grabbed my headphones and listened to some music. Ironically, the same song that I listened to before going into surgery played that night; John Mayer, ‘Why Georgia’ with a line that resonates with me, “Am I living it right?”
Coming to Cleveland is always a homecoming. Not just the visits with family and friends, but after working with the FES Center for 11 years it’s like entering a Norman Rockwell Thanksgiving. Aside from the work we have to do, the days are filled with hugs, welcomes and catch-up conversations. Our physical therapist keeps me in order.
We had two days scheduled in the laboratory. On day 1 we get right to work. This is a smaller team than the army we had for the surgery. The team in the lab consisted of the physical therapist, 2 engineers and the principal investigator, although he keeps a comfortable distance to allow the other members to do their work. With some baggy shorts on, I transfer onto a rehabilitation mat with an adjacent table filled with coils, external control units, and recording papers.
Our first rule of order is the profiling. This is a procedure used to test each individual electrode to understand the threshold and saturation points. Ok, what does that mean? In layman’s terms, we are trying to find the setting, when an active electrode produces a visible contraction of the stimulated muscle and also to find the point when the maximum stimulation is both tolerable and does not produce an adverse effect. “Current (milliamps), pulse width (microseconds) and frequency (hertz)” are all components that can be tweaked to create an optimal contraction of the muscle. We perform this testing for each of the new channels. The physical therapist is watching any movement of the muscle and any ‘overflow’ to other muscles. This is graded according to standard PT ratings of 0-5 (with 0 = no movement to 5= normal function/strength). During the testing, the engineer is working his magic with the external control unit pressing buttons so fast that it sounded like he was producing his own Morse Code. For the original system, this process took about an hour. For the new system, we scheduled three hours. It just was not enough. Maybe it was the interruptions, the side conversations, the testing of new electrode combinations or addition trouble shooting. By mid-day, we were not nearly done. We did confirm that one hour profiling sessions are a thing of the past.
The highlight of the profiling session was the use of the new cuff electrodes implanted around the femoral nerve to control the quad muscles. Only a few people have been implanted with this technology on the femoral nerve. The cuff electrode has four channels in each electrode and we are able to test each individual channel to see how that specific stimulation impacts the group of quad muscles. While lying on my back on the mat, we placed a bolster under the knees. Here we turned on the channels in the cuff electrodes and watched how the stimulation would contract the quad muscle to extend the knee and straighten the leg. We first contracted the quad using the original epimysial electrode into the quad. It would straighten the knee and lift the foot off the mat, but there was minimal strength; the therapist was able to push the leg back down with one finger (see video Leg Lift with Original Electrode on the Quad Muscle). We then contracted the quad muscle using the new cuff electrode. My leg straightened out with full force and the therapist grading the movement with a 5 for full extension and strength (see video 2 below Leg Lift with the New Cuff Electrode).
Leg Lift with Original Electrode
Leg Lift with New Cuff Electrode
Watching the leg kick out is a visual I still love today. And apparently, research team members like it too. During the long profiling process the Principal Investigator kept coming back to the mat to inquire about the cuff electrodes, like a kid on a long car trip “Are we there yet?” Then the chief surgeon came in and wanted to see the ‘new quads’ then the center director came in to see it yet again. My kicks were so good, we have visions of becoming a football place kicker or a Rockette.
After profiling, there were additional hours on the Biodex machine to, yes, test the cuff electrodes. Now dubbed ‘pulse pumping’, the experiments are trying to find a more effective and efficient way to test the electrodes and further understand the fatigue levels with multiple pulses while varying the resting time. I can’t tell you how many hours I have spent on this machine but it is a necessity not just for research but to help find the optimum system performance.
Day two and we are back on the mat to tweak more contraction combinations for functional performance. Unable to stand yet, the functional uses of the system include trunk control in the wheelchair and gluts shift for pressure relief. Once we completed the tweaking, the engineer takes the external control unit back to his office to do some final programming. Meanwhile, the therapist is reviewing the next phase of the research protocol, the ‘exercise phase’, which is designed to slowly build the strength and endurance fibers of the implanted muscles. There is not only an instruction sheet describing each exercise, but also a daily exercise log. Even though they are capturing the usage data in the external unit, they still want to understand user ‘compliance’. After about 20 minutes, the engineer emerges with a UECU (see photo below) with an exercise plan. I’m back to the mat to test all the exercise patterns. Here I perform one set of each exercise while the therapist observes for any adverse reactions. Once we are happy with the exercise patterns, it is back on the Biodex machine for more testing. By the end of two days in the lab, my body is exhausted. The amount of physical exertion is deceiving.
What did we learn with all this testing? First, we discovered the proper settings to begin the exercise phase. Second, we found one channel on the cuff electrode that is not providing the same quality of contraction as the others, which is to be expected. That’s the whole reason for having multiple contacts within the cuff anyway. We are not exactly sure what is happening; it may be that the contact is simply over connective tissue or the sensory part of the nerve that wouldn’t cause a muscle contraction. We’ll watch it closely and re-test it on the next visit. Regardless, the remaining channels provide super strong contractions and we are confident that I can stand without this problem child. Finally, we learned that we need to schedule more lab time for testing and profiling.
They sent me home with a case full of ‘toys’. We have a UECU with customized exercise patterns, multiple coils, auxiliary batteries, and battery charger; and a mission to start exercising. Resting time is over. It is now my job to get up and to exercise. The exercises are necessary to build up muscle strength and endurance in preparation for the first stand using the upgraded system. We now enter eight weeks of exercising and monitoring of the system. Body builders have nothing on me.
Some recent Facebook postings inquired about additional ports on the external control unit (UECU) suggesting to add a portal for a cell phone, computer and USB drive. Ok, so we have a world of multi-tasking. In this case, I’m like a 2 year old learning how to stand. It is safe to say that I should stay focused on the task at hand.
As we integrate our lives with technology, we become more power hungry. Going through the airport the other day, I couldn’t help but notice the gathering of people huddled around power supply stations. We even have portals under the airplane seats. As we become more mobile, we rely more on battery power.
These inquiries touch on a key issue for so many devices that are implanted into the human body. How do we power it up? Today, there are pacemakers and spinal cord stimulation systems with implanted batteries. This works for devices that only require a very low current. For a system like mine, the need for power is too great for the currently available implantable battery technology. Therefore, the power source is external.
To power up the implanted standing system, the UECU holds the rechargeable batteries and it transmits the power via high level radio frequency or RF thru the coil and to the implanted receiver. As long as the UECU is on and the coil is coupled with the receiver, then there is power going to it. Like talk time on your cell phone, the system draws more power when it is stimulating than when it is idle. Use duration for one battery charge is approximately 2 hours. In other words, I can get 2 hours of stimulation without recharging the batteries. At this point in the exercise regime, I am stimulating for about 2 hours per day. This is why I also carry a small auxiliary battery with me.
Recharging the batteries is not as mobile as the small charger coils for a cell phone. Oh no, it is much bigger. Named by Tim, the “car charger” is a big black box weighing in at about 5 pounds. The reason the battery charger is so big is that the FDA requires several safety measures. Some of these measures are in place to allow me to receive stimulation while the UECU is connected to the ‘car charger’.
The system is power hungry and the addition of a laptop or cell phone connection is not feasible. So, don’t expect to see holiday lights flashing from my head while I am using the UECU. That would have to be part of a different research project.
Four weeks have now passed in the exercise phase of the research protocol. A total of 8 weeks are required before I can start to use the system for standing. What have I noticed since I started using the implanted electrodes to build the tissue in my paralyzed muscles? Here are three key observations.
One of the daily exercises is leg lifts. Here, I use the stimulation to lift the legs against gravity by extending the knee. The exercise is designed to build the quadriceps muscle group in the front of the thigh. After 2 weeks of exercise with no weights, the therapist gave me clearance to add ankle weights until I observe fatigue. Well, I’ve been progressively adding one pound each day. I’m now at 9 pounds with no fatigue. I either buy more weights or start with more repetitions. To give you a perspective, before the recent upgrade surgery, I could perform leg lifts using stimulation from the original system and maxed out from fatigue at 3 pounds. I am now at 9 pounds and potentially seeking more. Conclusively, the quadriceps are building nicely. This muscle group is extremely important to be able to stand out of the wheelchair and also to remain standing.
Another observation from using the implanted system for the past few weeks is the coupling of the external coil to the new receiver. Coupling is a term used to ‘match up’ the external coil to the implanted receiver in order to properly deliver the signal from the UECU (Universal External Control Unit) to the receiver. If the coil and receiver are not coupled, the implanted system will not receive the stimulation. With the upgrade, I now have two receivers implanted into the abdominal area. The one on/in the left side is the original IRS-8 and the one on/in the right side is the new IST-16. After using the IRS-8 for so many years, I know the best place to tape the coil to the skin over the receiver. It is almost automatic like popping in contact lenses every morning. However, I find that the placement of the coil over the IST-16 is still not perfected. I am still trying to find the optimum placement on a daily basis and how to rotate the coil around the skin for the best comfort and a good signal. I’ll attest this to user adaptation since each user has a different anatomy. This exercise phase is truly the time to figure this one out!
The third key observation in this exercise phase is the change in the Extends All exercise. The Extends All pattern is designed to build the endurance fibers in the implanted muscles. This exercise is performed by lying on my back with my legs out straight. All of the implanted muscles tighten using stimulation at the same time for 10 seconds followed by 10 seconds of rest. This pattern continues for 60 minutes with minimal motion of the legs. I had this exercise pattern with the original 8 electrode system and used it frequently to control my spasticity. Now with the upgraded system and more electrodes the same exercise pattern is using more muscles. Boy, do I feel it. Near the end of the 60 minutes, I am thirsty for water, begin to feel fatigue and become warm from the ‘workout’.
Still these exercises build up the implanted muscles and I have progressed to exercising two hours per day. However, this is no substitute for exercising other parts of the body. Even though I am getting great movement, circulation and stimulation, I still need to pay attention to cardiovascular exercise and a workout of the upper body. A key area that tends to be overlooked when working with people with paralysis; We need a full body workout just like those with able-bodies. We need to exercise our moving limbs, our cardiovascular system AND our paralyzed limbs.
The UPS man struts up our driveway to the front porch where he is greeted by our muscovy duck who has nested under our jasmine bush. He drops the hard black case by the door and shouts thru the open window, “UPS”. I make my way to the front door just in time to give him a wave for the day. This routine happens every two weeks.
Since bringing the UECU (Universal External Control Unit) home in mid-October, we have started a ritual called the ‘UECU Swap’. For this exercise phase, the swap occurs every two weeks. The main purpose of this ‘swap’ is to progress the exercise patterns to work on endurance to prepare for standing. Just as physical trainers will add repetitions to a routine, the therapists and engineers are adjusting the exercise patterns. For instance, there is an exercise pattern called ‘Extends All’. This routine delivers a low level of stimulation to all the electrodes; oscillating on and off over an hour. The purpose is to build the endurance fibers in the stimulated muscles. As I progress over time, they are increasing the stimulation time. Recently, the pattern changed from 10 seconds of stimulation and 10 seconds of rest to 15 seconds of stimulation and 10 seconds of rest.
In addition, while I use the UECU, it records usage data. The usage data is basically recording the patterns that I use with the UECU. For instance, it is not only recording how many sets of leg lifts I am doing, but also the date and time that I am performing that specific exercise. They need this data for analysis later in the clinical study. In addition to the usage data collected by the UECU, I record the repetitions and duration of the exercises, along with the weights that I am using, on the paper exercise log. While the UECU can monitor the amount or time of exercise, it can’t record the amount of pounds used for ankle weights and it can’t record if I am watching David Letterman or Conan O’Brien while exercising. But it records enough so the research team knows if and when the exercises are being performed.
Every two weeks, I receive a ‘fresh’ box. It contains a UECU with amended patterns and a clean data log. I return the UECU that I have been using which holds the data for the past two weeks. It is packed up into the hard black case along with the exercise logs. I schedule a UPS pick up and set it on the front porch. Then I await the afternoon greeting through my front window, “UPS”.
Back in the Saddle Again
As I am rounding out the final few weeks of the exercise phase, I have reached yet another milestone in this long process. I’m back sailing…ok other watersports too.
Learning from this experience, the human body takes a long time to heal. It truly is all relative. But from the perspective of the person eagerly waiting to meet the healing milestone, it takes a very long time. And the final days are even longer, like those last few days before Christmas. Almost 3 months after the surgery in August, I am now released from the restriction on watersports. Six weeks after the surgery, I was released to daily transfer counts, the ability to lean and bend over and regular daily activity. However, I was still restricted from any watersports.
I fully understand why the research team decided to extend this limitation but it does not make the wait any easier. The extra months allowing the body to heal and the tissue to grow around the new technology helps to ensure that when I start banging my body around, the technology should remain anchored.
For the average person living in cooler climates, this constraint may not seem like a big deal. For me, however, it is a long time off the water. Living in Florida, the fall and winter seasons mark the perfect time to get outdoors. Canoeing and kayaking is great this time of the year. It also marks the start of the sailboat racing season in the South. As a member of the US Sailing Team Alphagraphics, I have been restricted from the sport I love and valuable practice time as we gear up for the US Paralympic trials; which will determine the team to represent the USA at the 2012 Paralympic Games in London. My teammate, JP, has been extremely patient. We have taken the time to do the much needed boat work and administrative tasks that also go along with campaigning for the Games.
Getting back on the water truly marks the end of the recovery phase. I am finally back to my normal activities. I was back on the water the day after Thanksgiving with the weeks following filled with team training camps and competing in the US Disabled Sailing National Championship.
Maybe I’m like a kid who gets to eat Fruit Loops at the grandparent’s house while at home the parents only allow organic granola; I am gorging in excitement. After being prohibited from sailing for 3 months, I am back on the water and in the saddle again. Follow our team at www.j2racingusa.org
Rejoining the Upright World – Part 1
December is not the ideal time to travel from Tampa Bay to Cleveland, but in this case it was a good exception. A few days before making the trek north, the headline news was about a snow storm crippling the Midwest. The storm was expected to hitthe Cleveland area on the same day of my scheduled arrival. Regardless, the flight was not delayed, let alone cancelled. Putting on every layer of clothing I own, I made my way to Cleveland. Landing with the white fluffy snow coming down as the flight attendant welcomed us to Cleveland. This was the beginning of 4 stacked days with the research team. Here is when the eight weeks of exercise should pay off.
As I was getting ready for my mom to pick me up for our drive to MetroHealth Medical Center, my sister raps on the door. “You know, over 400 area schools are closed due to the snow storm. You may want to see if the research team will cancel.” Yeah, Welcome to Cleveland and the signature Lake Effect snow. Images of delayed labprogress, treacherous driving conditions and freezing temperatures start flying around in my head. With that, I startedcalling members of the research team. The diehard Ohioans were making their way into the lab and they were expecting me to be there too. In the end, the roads were not bad and we were able to start the first day of testing with only an hour delay.
After the ritual hugs of hello, we made our way back to the lab for the first priority at hand, profiling.This is the process of testing each individual channel of the system. The testing is done on a therapymat. The first channels to test are those in the quadriceps. To do this, I lay supine on the mat and we place a bolster under the knee. We then connect the coils to a UECU programmed specifically for testing. The engineer operates this UECU titled the‘Morris Code Box’ because the engineer clicks the buttons so fast that it sounds like Morris Code. We test thechannels for the right side first. He turns on one channel and begins to turn up the juice and the leg begins to extend. He gets to 200 milliamps and the knee drops down and gets weaker. The therapist asks to repeat the process, while I hold my breathe hoping that nothing is wrong with the system. The second time around shows the same results and the third round is the same. We stop, perplexed. The engineer looks down and says “I’ll be right back”. We rushesback to his office to reload the programs into the test UECU. When he arrives, we plug everything back in and Voila! It works. Apparently, the programs did not download correctly into the test unit. We repeat the test on the same channel and it is all ok.
During the first profile in October, we discovered one channel in the cuff electrode that was not responding. That channel has been turned off for thepassed 8 weeks. At this point, it was time to turn it back on to test the mystery channel. To our surprise, whenwe turned the channel on, it performed as it was designed to do; it contracted the right quadricep. With a few more tests and we are able to use this channel. This was probably one of the most eventful profiling sessions we have had.
With the profiling complete and still on the mat, we begin to play around with the trunk control patterns.This pattern uses 3 sets of electrodes. Those implanted in the gluteus maximus, quadradus, and erector spinae. The key thing that we are trying to find is the best settings to get a balanced sitting posture without spillover to other muscles and a comfortable contraction. Once we find the proper settings, I’m off the mat and onto the Biodex machine.
The Biodex machine is a testing unit. I have spent many hours on this machine and my log time will not end any time soon. The main goal is to test the channels in thecuff electrodes. The lead engineer in this area of research is trying to understand the channel that produces the strongest contraction, the setting where spillover to other muscles begins and what oscillation patterns he can develop to decrease fatigue in the coveted quadricep muscle group.
After a lunch break, we are back in the lab. The afternoon holds the climax to the eight weeks of exercise, the first stand with the new system. We test a few more patterns before the initial attempt. Cameras are in place and the parallel bars are reassembled. Ok, are we all ready to stand? The therapist is the one in charge and she makes the call “Now”. I press the little green button to activate the system, the muscles contract and I stand straight up. Towering over her as she remains seated onthe PT square stool guarding my knees. That stand feels so good! But after only 1:30 minutes, my left knee begins to buckle as a sign of fatigue and the PT gives the command to sit. I try not to wear the emotion of disappointment on my face, but it obviously shows. Attempting to provide words of comfort, the principal investigator says “Jen, you haven’t stood in four months. Remember your first stand (11 years ago) was less than that.” It doesn’t work. Now we need to troubleshoot. We do a few moreshort stands and observe that I am standing with all my weight on the left leg and the right leg is off the ground. Wecall it a day knowing that we have a few more days to troubleshoot the system. If it was easy, then it wouldn’t be science.
Today, my mom and I meet members of the research team at the Louis Stokes VA Hospital. We are at the VA Hospital to run several tests using the new trunk control patterns. One particular test is to see if the trunkpatterns will assist with wheelchair propulsion. The therapist set up a course around an inpatient ward. The experimentwas to propel the wheelchair as far as I could within a 6 minute duration. We did this without stimulation, with full trunk stimulation and with reduced trunk stimulation. We ran 2 tests with each scenario. Talk about getting my workout for the day. I was wheeling as fast as I could around thenurses’ ward while the therapist ran/walked along side me to help clear the way. By the time we did the third test, we had our cheering sections at various parts of the course, I almost ran over a nurse and kept the janitorial team on their toes. While still at the VA, we meet up with other members of the research team to test ramp patterns and pressure relief patterns.
For the afternoon, we make our way back to MetroHealth Medical Center for more testing on the Biodex machine. We all agreed to stay late in order to complete the tests. The engineer would take the data and crunch the numbers over the evening in order to be armed with information to help us troubleshoot the standing pattern during the next day.
After four full days in the Cleveland lab, we had many hours of testing, discoveries and some surprises. There is much to tell and this will be a lengthy entry recounting the experience.For those readers who prefer to cut to the chase, I stood successfully and scroll down to see the before and after video. For those readers, who prefer to review thejourney to get to the successful stand and some other cool features, please read on.
To be continued…
Rejoining the Upright World – Part 2
Half way through the four day schedule and we have a lot of work to accomplish. We start Day 3 by meeting the engineer who crunched the numbers over the evening. I’m back on the machine to start the day. For these tests, we are experimenting with various combinations to oscillate the channels in the cuff electrodes to reduce fatigue. We try several different combinations.
Testing completed and it is time for the DEXA scan. A research team nurse escorts me down to the Clinical Research Unit (CRU) for the test. The CRU is the special area in MetroHealth Medical Center where I was for inpatient recovery after the implant surgery in August. Here I was able to revisit some of my favorite nurses. The DEXA scan uses laser technology to scan the body and analyze bone density. For people living with chronic spinal cord injury, brittle bones and osteoporosis is a common health risk. Being 11 years post injury, I was expecting bad news. To my surprise, it was quite the opposite. The results from scanning my pelvic area showed that my bone density is within normal range for a woman of my same age, height and weight for an able-body. Yes, that it right. After 12 years of being a wheelchair user and an electrical stimulation user, my bone density is normal. Unbelievable!
With the results in hand, we head back to the lab for an afternoon of tweaking the standing parameters. To give ourselves a reality check, the engineer loads the original standing patterns that I was using before the implant surgery in August. I stand with the original 8-channel system and the physical therapist says, “I am not impressed.” We then turn back to the standing pattern with the new system. I stand and she says, “I’m still not impressed.” Now, we have some problem solving to do.
The first challenge is to get me standing on both feet. On Day 1, we discovered that I was weight bearing on only one leg. The suggested solution from the research team is that the gluteus medius on the left side is pulling the hip up on the right side. We gradually reduce the gluteus medius on the left until the right hip lowers and I am standing solidly on both feet. Problem 1 solved.
The next standing challenge is to figure out why my left quad muscles are fatiguing within only 1:30 minutes. A theory points to the stimulation of the quadriceps muscle group. With the new system, I am standing with 5 channels of stimulation on each quad; 4 channels in the new cuff electrodes and 1 epimysial elelctrode from the original system. We think that we are over stimulating the muscles which is resulting in a fast fatigue in standing performance. We use the data from the dynamometer testing to help us. We first turn off the original epimysial electrode. I stand without much difference. The engineer reviews the data and finds the 1 channel in each cuff electrode that provides the strongest muscle contraction. From there the standing pattern is programmed to stand on just one of the 5 channels in the quad. I stand for 7 minutes. We are on to something. We then program to stand with one channel and the second strongest channel without any spill over to the other muscles in the group. We turn down the stimulation to 50%. It works. I stand for only a few minutes but we know the problem is solved.
The final challenge for the afternoon is to test the swing thru gait. This is using the walker to pull the body off the ground, swing the legs forward in order to move around short distances. We find that my right hip is flexing and the right leg is swinging far forward and I am barely landing on the heel. We begin the test the stimulated muscles to find the culprit that is flexing the hip. The tests point us to the right back electrode. We gradually turn the stimulation down. It reduces the problem but does not solve it completely. At this point, it is late in the day, the team is getting burnt out and I am beginning to fatigue. It is time to call it a day and start fresh the next and final day in the lab.
Day Four – Final Day
Going into the home stretch, our priority is to perfect the standing performance. The first order at hand, stand with fresh muscles and see if the right leg still kicks out. First stand of the day and the right leg is still kicking out.
We head back to the therapy mat for more problem solving. The therapist is starting to work in an order to find the culprit while the engineer programs the patterns using the Morse Code box. We find that the quad muscles are inducing a slight flexion. We turn back to the data collected from the dynamometer testing. The engineer finds the next combination of cuff channel electrodes with maximum stimulation and minimum spillover. We try two different channels; one at full stimulation and the other at 50%. We see some improvement but it is still not the best but it looks good enough to take home and begin working with it. We then rebalance the other electrode patterns for a final standing pattern and I’m back on the dynamometer for more data collection.
We round out the final hours going through our check list, we do a balance test, find the final settings for exercise patterns and then the ‘Stand to Fatigue’ test. Here I stand for as long as I can handle or until there is a sign of fatigue, whichever comes first. The first stand to fatigue test using the original 8-channel system 11 years was about 2 minutes. With the new system is was 24:49. Quite a difference.
While the engineer returns to his office for the final programming of the take-home patterns, we reflect on the 4 days with the therapist. There has been a lot of testing. There are new patterns to try at home including, the wheelchair propulsion, trunk control, massage, exercise and standing patterns. My challenge is to take the UECU home use it in the real world and report back to the research team. We will regroup in the spring to tackle the next phase. There is still a lot to do in the studies. If it was easy, it wouldn’t be science.
Check out the video of the standing patterns.
This video is using the original 8 channel system. Observe my posture and how the right knee buckles while standing, which shows fatigue.
The second video is using the new 24 channel system. Observe the straight posture and the solid knees. The stand is effortless with little use of my arms on the walker.
Christmas came early for me. (For the Wombat fans, I’m not moving to New York)
Relieving the Pressure
Standing with the new system is really cool but it is the not end point of this research. The first stand simply marks the end of the installation & recovery phase and the beginning of the rehabilitation and functional use phase of the protocol. Standing in the lab answers the question, “is it possible?” but it doesn’t answer the question, “how will it be used?”
As a clinical trial participant, this is when the rubber meets the road. When the input provided helps to drive the discovery of research. In December, the research team sent me home with the new standing patterns and the ability to stand. For the next several months, it is my job to build standing endurance, improve my comfort level with the system, and push my ability to move around using a walker.
But that is not the only challenge the research team issued. The external control unit is stacked with different functional use patterns. Patterns for pressure release, trunk control, and wheelchair propulsion, to name a few. Over the next few months, I am challenged to use these patterns in the ‘real world’ and report back to the research team. Over the next several entries, I’ll be introducing you to these patterns, relaying some of the uses and asking for your suggestions through social networks like Facebook, Plaxo and LinkedIn.
The first pattern I put to use was on the flight back to Florida. For anyone who has flown coach class lately, those seats seem to get smaller and smaller. For a wheelchair user, traveling on the airlines means handing over your only means of mobility. People get upset about taking off their shoes through security. Imagine leaving your only means of getting around in the world on a jetway.
Packed like sardines, there is not a lot of spare elbow room. This leaves a difficult challenge to be able to do a proper pressure release. Pressure releases are done to prevent pressure sores or decubitis ulcers, otherwise known as bed sores. According to the Department of Veteran Affairs, 1/3 of people with spinal cord injuries develop pressure sores. Complications from them kill approximately 60,000 Americans a year; twice the number who die from prostate cancer. One sore can take a person out of daily life for 6-12 months and treatment costs can be between $50,000 to $100,000. It amazes me that our health care system spends more effort to treat pressure sores rather than prevent them. According to many insurance companies, pressure sore prevention is ‘custodial’.
For people living with spinal cord injury, prevention is not custodial; it is a constant battle to protect boney areas such as the butt, spine and heels. The quick and cheap prevention method is to lift oneself every 15 minutes to relieve pressure. How practical is that? For some who cannot lift themselves, it is not. And for those that can, there are situations, like an airline seat, where it is not possible.
There is a small team of researchers in Cleveland who are studying pressure points for wheelchair users and discovering ways to use electrical stimulation for prevention. I affectionately called them the “Butt Team”. While in Cleveland, we conducted several tests of different pressure relief patterns for their data collection. To conduct the tests, they place a sensory mat on the top of my wheelchair seat cushion and I transfer onto it. This mat is connected to a computer. Using the implanted electrodes, we run about 12 different series of patterns and watch on the computer screen as the pressure changes in the seated pattern. The muscles stimulated in these patterns are: the gluteus maximus, and core muscles (erector spinae and quadratus lumborum). As the electrodes cycle on and off, the computer screen shows areas that change from the color of red (high pressure points) to blue (low pressure points). This is one of the most significant and compelling concerns for people with spinal cord injury.
Back in my airline seat, I settle in for a 2 1/2 hour ride from Cleveland to Tampa. Pressure lifting every 15 minutes is not possible. The research team has given me two patterns to test for pressure release: ‘Glut Shift’ and ‘Glut Shift with Backs’. For the ride down, I flip on the external control unit and select ‘Glut Shift’. The pattern oscillates the right and left butt muscles on and off. You can see me sway from side to side but not enough to disturb the person next to me. This is pressure relief for my butt but not my spine. The pattern labeled ‘Glut Shift with Backs’ stimulates the butt muscles and the back muscles too. This is perfect for sitting on a surface with high back support, like an airline or car seat.
Long periods out of the comfort of my wheelchair seat are prime times for the development of pressure sores. These patterns are a great addition to the arsenal for prevention. Where else can I use it? How can I try it in the ‘real world’? That is a question to those on the social network. In the meantime, don’t be surprised to see me swaying from side to side, even with no music.
Looking at wheelchair users, we often focus on the mobility issue. I am often asked the question “Will you walk again?” But for those with spinal cord injuries, there are so many other ‘hidden’ issues that can make dramatic impacts on quality of life; like bladder function, sensation or spasticity. Don’t get me wrong, if I could walk like I did prior to my injury, I’ll take it. In the meantime, there are ways to make life easier as a wheelchair user.
In this research phase, I am challenged with exploring the function patterns provided in the implanted standing system. One of those patterns is ‘trunk control’. The trunk plays a critical role in functional standing. When referring to the trunk, it is the area from the hips to the breast line. These are the muscles often described as the ‘core” muscle groups.
Trunk stability is a desire among people with spinal cord injuries. According to research published by Dr. Kim Anderson, “Targeting Recovery: Priorities of the Spinal Cord-Injured Population”, trunk stability is the third highest priority among people living with quadriplegia and paraplegia.
Trunk stability influences how I function in the wheelchair. With my level of spinal cord injury, I am unable to sit without support; I need either a seat back or hold myself with my arms. With the electrodes turned on, I gain a very straight and effortless sit. Another example is when I reach up for something. I do not have the core muscles to hold myself up. To do so, I use one arm to hold myself and one to reach. Sure, they sell fancy reachers, but anyone who has used one knows that they just don’t compare to the use of a functional hand.
With the new implanted system, we have added more muscles to the stimulation pattern for trunk control. With the original system, we only stimulated the erector spinae. That gave some trunk control but it was like sitting on a stilt. If I lost balance, I would fall back in the chair. With the new system, we are now stimulating the erector spinae but also the quadratus lumborum and the glut muscles. My posture is straighter and I am much more stable when the system is activated. See the video below to see with stimulation on and off.
Who doesn’t like a good back massage? What if you could get one for free at any time?
As a participant in a clinical research trial, investigators can try to predict different outcomes but they truly do not know until they start working with people; particularly people who can give them feedback. In that valuable feedback, we find unexpected benefits.
While in the Cleveland laboratory, we did several tests on the dynamometer. One member of the research team is an engineer dedicated to the exploration of using various channels in the cuff electrodes in order to reduce fatigue. The cuff electrodes are the implanted electrodes that are wrapped around the femoral nerve. Within one implanted electrode are four channels. The challenge is to create the optimum pattern of oscillation of turning the channels on and off to provide muscle stimulation for standing and rest time for the muscle. The goal is to increase the time it takes for the muscles to fatigue. The dynamometer is the main tool to gather data to get the various experimental patterns.
One morning during my visit to Cleveland in December, we arrived at the laboratory for a two-hour session on the dynamometer. The engineer and the principal investigator (PI) were both present. The PI is obviously excited about this research. This is obvious when he was climbing over other equipment to capture the testing activity with his video camera. After a few tests, the engineer and I got into a routine.
For one test, we were gathering data for a vibration pattern. He said, “Ok, I am going to turn on your right quad. Ready?” I respond, “Ready.” As we are both looking down at the right thigh muscle, the engineer pressed the start button. Nothing happened. He had a very perplexed look on his face. Then I said, “Well, you obviously did not turn on my right quad, but you did turn on my right back muscle. And it feels really good.” The vibrating back muscles felt like a full massage chair.
The muscles that he activated using the vibration pattern are in the lumbar spine area. For anyone who sits for long periods of time, back pain is a common problem. The same issue can apply to wheelchair users. Of course, I inquire about taking this new Back Massage home with me. Now, within my repertoire of functional patterns for the implanted system, I now have a mobile back massager. What an unexpected benefit!
Test Pattern in the Real World
When an opportunity knocks, it’s time to take it.
One of the testing patterns the researchers provide in the external control unit or UECU is a wheelchair program. It was created to help with propelling a manual wheelchair.
The pattern provides stimulation to the gluts providing stability to the hips in the chair. The pattern also includes stimulation to the erector spinae and the quadratus lumborum. This provides trunk control but the stimulation thresholds are lower. This allows enough movement of the shoulders to make the wheeling on uneven surfaces easier. Without the stimulation, I would normally wheel a long incline with my torso far forward trying to get the maximum weight forward in the wheelchair.
In my regular daily schedule, I propel mostly short distances. Would I really use a wheelchair propulsion program for this application? No. But there are occasions when I do need to wheel longer distances. While in Miami for the 2011 Olympic Classes Regatta or MOCR, such an opportunity did arise.
The Sunday after racing concluded, the US Sailing Team Alphagraphics had a mandatory meeting at the Coconut Grove Sailing Club on the Biscayne Bay waterfront. At the same time, the Miami Marathon was underway with many road closures in Coconut Grove. Getting to the meeting spot was just not possible with a vehicle so I decided to “huff it”. Tim dropped me off about 10 city blocks away from the meeting spot. It was clearly time to get the morning workout and wheel the way to the waterfront. It was also an opportunity to try the wheelchair propulsion pattern.
Typically when I wheel longer distances, I need to stop to readjust my positioning in the wheelchair, sit up straighter, readjust my legs or straighten my hips. But while using the wheelchair propulsion pattern, this was not the case. The stimulation kept my body firmly into the wheelchair making distance wheeling much easier. I did have to get used to the stimulation and having a bag on my lap, but overall the wheeling was less effort with the stimulation.
As I arrived at the Coconut Grove Sailing Center, the meeting was on the second floor. Absent of any elevator, the way to get to the second floor is via one of the area’s longest ramps. This ramp met ADA codes for gradient but it had 6 legs doubling back to get up to the second level. This was huffing it for sure! My first attempt ascending the ramp was with the stimulation. It was no easy attempt but I tried it and made it up with little hesitation, even with the rubber mat obstacles at the top. I didn’t think the stimulation was much help.
But later, we went down the ramp for team photos and then needed to ascend back up the ramp for the remainder of the team meeting. The second attempt ascending the ramp was without stimulation. What a difference. I ascended the ramp much slower causing a back up of other wheelchair users. My arms started to “feel the pain” since I did not have the stimulation for the trunk muscles to help with the propulsion. Now, it was clear that the wheelchair propulsion pattern did help when maneuvering up a ramp. Being more erect while wheeling an incline is counter intuitive from what I have been taught for wheelchair skills, but it works. I’m sold.
Feeding the Addiction
Spasticity. For those living with spinal cord injury (and other neurological conditions like multiple sclerosis, cerebral palsy and ALS), it is a ‘secondary’ condition that raises it’s ugly head if not treated. Spasticity comes in many forms. Spasms can come at any time and without warning.
According to the National Institutes of Health:
“Spasticity is a condition in which certain muscles are continuously contracted. This contraction causes stiffness or tightness of the muscles and may interfere with movement, speech, and manner of walking. Spasticity is usually caused by damage to the portion of the brain or spinal cord that controls voluntary movement. Symptoms may include hypertonicity (increased muscle tone), clonus (a series of rapid muscle contractions), exaggerated deep tendon reflexes, muscle spasms, scissoring (involuntary crossing of the legs), and fixed joints. The degree of spasticity varies from mild muscle stiffness to severe, painful, and uncontrollable muscle spasms.”
When I was first injured, I had a doctor explain to me that I would develop uncontrollable muscle spasms that I would have to manage on a regular basis. She wasn’t kidding. Within a few months, I developed the muscle spasms as she described. At times, they were so bad that a spasm would throw me out of my wheelchair.
There are ways to manage spasticity. At first, I tried the common way, pharmaceuticals. Basically, they are muscle relaxing drugs, but I found that I couldn’t mentally function while taking those drugs and I stopped. There are other ways to manage spasticity; standing, electrical stimulation, yoga and stretching; which leads me to how the new implanted system helps me to manage spasticity.
There are two ways that I have been using the implanted system to manage spasticity. Standing with the system is the obvious way. The more I stand using electrical stimulation, the more my muscle spasms ‘relax’. Tim and I went canoeing for a two day excursion in southwest Florida. Figuring we had enough equipment to bring with us, I opted to leave the walker behind and not stand for 2 days. Within 24 hours, the spasms started to come back. Within 48 hours, my body was craving a stand. I had to feed the addiction.
The other way to manage spasticity is by using a pattern called ‘Extends All.’ This pattern is an exercise function that turns all the implanted electrodes on for 20 sec and off for 10 sec. The duration of the pattern is an hour. This pattern was originally created to build the endurance fibers in the implanted muscle groups. But more importantly, I found the pattern really helps me manage spasticity. It relaxes my muscles so the spasms don’t awaken me in the middle of the night.
Some say that managing spasticity using electrical stimulation is a double edged sword. On one hand the electrical stimulation relaxes the frequency of the muscle spasms, but on the other hand, the spasms that do occur are stronger. I can attest that this statement is true, at least for my case. Using electrical stimulation is not a quick fix either. IFESS (International Functional Electrical Stimulation Society) warns that the maximum benefit of using electrical stimulation to manage spasticity “may not be realized until ES (electrical stimulation) has been used for 1-2 hours per day for 1-3 months.”
For me, keeping a daily exercise regime to manage a few occasional spasms is a feasible solution. With that in mind, I continue to feed my addiction to electrical stimulation and keep the spasticity monster at bay.
Going the Distance
Ok, using the new implanted system, I’m able to stand with a walker. But I was able to stand with a walker using the original implanted system. What is all the hype about? On the surface, it appears to be functionally the same. In reality, the new implanted system provides those small upgrades that make a big difference, almost like going from the 3G network to the 4G network.
However, as with any phase of this research process, results are not instant. When I first stood with the new implanted system, the endurance test for standing duration was a maximum of 24 minutes. That is pretty good, but there is more.
One of the goals of this new upgraded system is to allow me to stand and move around short distances using crutches. Several years ago, I tried to use crutches with the original system. It was possible but very difficult. I never became independent with crutches and I was never functionally standing with the crutches. I went back to using the system with a walker and being able to functionally stand and move around.
At this point with the new system, I’m back to baseline and using a walker. On my next visit to the lab in Cleveland, we will begin working with the physical therapist to start the process of using crutches. Again, change is never instant.
How am I preparing for this next lab session in March? As a research participant, it is my responsibility to be prepared for each phase of the project. To prepare, I am working on increasing the daily standing time. Do I cheat? Well, yes. I have days when I only stand for 5-10 minutes. For the most part, I am at the level of standing for 30-40 minutes per day.
Endurance for standing is not the only skill. The other is getting balanced and comfortable with the new standing system. For building this skill, I am now doing laps. With a swing-through-gait, I lift the walker move it forward then lift to swing the body forward. When I lift the walker, I am gaining the confidence and comfort of being balanced with the standing system. The motion also builds my upper body strength and endurance. These are the same muscles I will need when we start working with crutches.
Slowly increasing the distance helps me prepare for the testing time in the lab. Committing to daily exercise and skill building will help the results in the lab. I just returned from a US Sailing Team training camp in Miami. While staying in my teammate and his wife’s condo in Coconut Grove, I was doing laps in the courtyard. The beauty of this implanted system is that regardless of where I may be, I can still bring the system with me. I can keep training to go the distance. Plus, I can continue preparing for our sacred lab time in March.
There have been anatomic challenges particularly when it came to the surgical implantation. Now, as I am using the system in the real world other technical challenges are starting to surface. Some have already surfaced and I have no doubt there will be more. Regardless, this is the reason for a clinical trial; it is a way to test the beta version.
One technical issue surfaced while using the system that relates to the coupling of the external transmitting coil to the implanted receiver. The receiver is fully implanted into the abdominal area and is powered and controlled from outside the body by communication with a universal external control unit (or UECU) through the transmitting coil. The coil is placed (taped to the skin) over the implanted receiver and connected to the UECU. The UECU sends messages through the coil to the implanted receiver to generate and deliver stimulation via the implanted electrodes. Getting a good connection between the receiver and the coil is called “coupling”.
Much like being in a wifi hotspot, the signal between the coil and the receiver can be strong with a good placement or weak if the coil is not placed properly over the implanted receiver. The system was designed to maintain good coupling as long as the coil is within about an inch of the receiving antenna of the implant. The coils are available in two lengths, short form of about 24 inches or a long form which is 72″. With the new IST-16 implanted receiver, we have discovered that the coupling of the coils is different between the short and the long versions. If the coil with the long cable is placed properly over the implanted receiver, then the signal is strong and consistent. But with the shorter cable, the coupling is much more sensitive to the position of the coil. Placement of the shorter coil needs to be much more exact than the longer one, and the shorter coil seems to lose communication with the implanted receiver more easily s the skin over the implanted receiver moves as I bend at the waist. When communication is lost and the system becomes “uncoupled” the implanted receiver can’t deliver stimulation. Fortunately, we discovered this when I was using the system for leg lift exercises and not while I was standing.
During my last visit to the Cleveland laboratory, we spent at least 2 hours trying to determine the appropriate power output settings to optimize the coupling. The solution was to control power output to the two implants independently so we could increase the strength of the communication signal to the new 16-channel implant. We agreed that I would try it at the new setting, give feedback, and make additional adjustments as needed. Right now my original 8-channel implant is set at ½ maximum transmitting power and the new 16-channel implant is set at ¾ maximum power, so there is still room to increase if necessary to improve the consistency of the coupling.
A higher power output results in a quicker drain on the battery. This means that I have less usage time before the battery needs a recharge. There is a safety feature for a low battery condition built into the UECU. If the battery runs low, there is a ‘Low Bat’ visual cue on the UECU display and a high pitch warning sound. The warnings were set to give at least 6 minutes of continued use until the battery is completely drained, which would normally be plenty of time to find a safe place to sit down and recharge. Even though a fully charged UEC can still run for a couple of hours at the highest power setting, I’m still getting used to the shorter battery life as the UECU now reaches the alarm state more quickly, so I have to be aware of that when I’m up using the system for functional activities.
These technical challenges don’t have a quick and easy solution. As each issue is discovered, the feedback is sent to the technical team who troubleshoots the problem for a potential permanent resolution. This is the process of effective technical design. I’m sure devices like the Android and the iPad were not perfect the first time out of the technical design lab. As with most new technologies, it takes people using the devices to discover the deficiencies to build an overall better system.
Ever test a beta version of new software? It may be a new feature on Google or new software developed by Microsoft, Oracle or Intuit? The purpose of testing beta versions is to find the ‘bugs’ in system prior to it being released as a final version. It is a way of finding technical challenges. These challenges just cannot be anticipated by engineering design but they surface as the technology is handed over to the user community. This implanted system is no different.
Homage to Lakeshore
Lakeshore Foundation is a one of the national training centers for Paralympic sports. Name a Paralympic summer sport and more than likely, it is represented at this facility; quad rugby, swimming, goalball, basketball, you get the point.
Arriving at the Birmingham airport, a big wheelchair accessible van is there for a curbside pick up. Piled into the van, we transport to the Lakeshore property and proceed up the winding path between buildings, dormitories, and rehabilitation facilities to the top of the hill where we arrive at the main training facility and athlete dormitory.
The 4-day visit is filled with activities from 8am through 9pm. The focus for the US Sailing Team this year is fitness and communication. On the fitness side, we review our exercise plans and meet with the therapist to review exercises that will best prepare us for the roles we have on the sailboat. Here is a photo of me and my teammate, JP, meeting with one of the trainers.
We also go through a battery of tests to benchmark our progress year over year. There are a variety of tests for speed, endurance, coordination and strength. This is also a good time to see if some of the stimulation patterns have an influence on the performance of these tests. Two tests in particular were prime ground for trying the implanted stimulation system to see if they influence the outcomes.
One test is strictly for measuring endurance. It is the 12-minute run/walk/wheel. On the track in the main gymnasium, we have a starting line and wheel around the track as fast as we can for 12 minutes. Now, 12 minutes does not seem like a long time, but try wheeling at full speed for that long and just one minute seems longer than you ever thought. In previous years, I ran this test without any stimulation and completed about 3960ft in the allotted time. This year, I performed that same task using the wheelchair propulsion pattern programmed into the UECU. The results: in 12 minutes I wheeled 4097ft. There does not seem to be a big difference between the two. However, there is a caveat. In previous years, I was using pneumatic tires and this year, I switched is solid tires which add more friction. The conclusion: we need more tests on the wheelchair propulsion pattern to see if there is a defined benefit or not.
The other test of the stimulation patterns in action is the ‘Trim Test’. Designed specifically for sailors, this is a test of pulling on 45 ½ ft of line with 25 lbs attached to the end and theraband on the end to add resistance. During the test, we pull on the line as fast as we can until we reach the end of the line. The observers measure the number of pulls and the time to complete the task. This is a measure of speed, coordination and upper body plus core muscle strength. It is a prime test for the trunk stimulation pattern. The trunk pattern stimulates the four electrodes in the back (2 on the erector spinae and 2 on the quadratus lumborum) plus the gluteus maximus muscles. The pattern provides good posture and core muscle support. At Lakeshore, we tried several different tests with different resistance levels and with and without stimulation. After several consecutive tests, we did not find a significant performance difference in the outcomes. However, the big difference was the observation by 3 team support staff. They all commented on how the stimulation provided a noticeably better posture and the mechanics of the movement was dramatically improved. Recommendations from the coach: practice more with the stimulation.
Even though we did not see the dramatic breakthrough in the performance data of the stimulation patterns, this was a good time to bench mark and see how it applies in the real world. Each test was only performed once. As any researcher knows, repetition will uncover the true data.
As we left the hill for the end of the weekend, we did have a great time improving our fitness potential and communication within and outside of the team. We even had some fun team building exercises like synchronized swimming and wheelchair flag football. Yes, I can be a line backer in a wheelchair.
Once per year, the US Sailing Team Alphagraphics Paralympic members trek to Birmingham, Alabama and the Lakeshore Foundation campus. There are 18 team members with a variety of disabilities; amputees, stroke survivors, spinal cord injury and visual impairments. It is a time that the team gathers together to check in with our fitness, physical training, nutrition, psychology and logistical programs for the sport of sail boat racing.
Lab Visit Testing and Experiments: Part 1
It comes with the territory. Being a participant in clinical research includes being involved with various laboratory experiments; some are simple and others not so much. They are all in the interest to develop a viable device. Over the 5-day visit to the Cleveland FES laboratory, we conducted an array of experiments with the standing system. Some related directly to standing performance but others are testing additional functional patterns of the system such as pressure relief, wheelchair propulsion and trunk control. This is an overview of the experiments from a participant’s perspective.
A unique feature of the upgraded system is the cuff electrodes hugging my femoral nerve controlling the group of muscles in the upper thigh area. One engineer is focusing on how to most effectively design and execute an oscillation pattern for the quadriceps to decrease fatigue and gain optimum performance while standing. For this visit, we had several sessions together on the dynamometer. For this visit, he focused solely on the right leg. Along the way, each new stimulation pattern adopted a new nickname like “sinusoid”, “carousel” and “vibration”. Most mornings, I would have coffee and dynamometer. We will not see the final results in this visit but it is a key step to getting to longer standing times.
Speaking of fatigue, we ran several stand-to-fatigue (STF) tests to determine my maximal standing times. With 4 different configurations, each day we would conduct one STF test. For each test, we would place our bets on standing duration. I would stand with the given configuration until I couldn’t handle it or a muscle showed signs of fatigue which is typically the bending of the knee or more pressure on my arms while standing. The configurations and standing times were:
- a. Standing with the original hips and trunk electrodes (Glut max, hamstring and erector spinae) and the original epimysial electrodes on the quads. Time = 3 min 40 sec.
- b. Standing with all hips and trunk electrodes (Glut max, hamstring, glut med, post adductors, quadradus and erector spinae) and the original epimysial electrodes on the quads. Time = 4 min. 7 sec.
- c. Standing with the original hips and trunk electrodes (Glut max, hamstring and erector spinae) and the new cuff electrodes on the quads. Time = 34 min.
- d. Standing with all hips and trunk electrodes (Glut max, hamstring, glut med, post adductors, quaddradus and erector spinae) and the new cuff electrodes on the quads. Time = 50 min 4 sec.
These STF times not only show the value of the new cuff electrodes but also the other new electrodes in my hips and trunk. Another area of experimentation was to develop a stimulation pattern to reduce pressure in the seated position. As written in previous journal entries, pressure sores are a constant threat to people living with spinal cord injury. If the stimulation can help prevent a pressure sore, it can provide great benefit not only to the person using the wheelchair but also the health care system.
On this visit the engineers tested 3 different pressure relief patterns to find out which would be most effective. For each variation, they would gather data on the oxygen in my skin using sensors taped to my rear end and the pressure on my seat using a sensor mat on my wheelchair cushion. For each pattern, they would activate the stimulation for 5 minutes and then have me sit quietly for 5 minutes. I think the sitting quietly was more of a challenge for me than for the researchers. Once the data are analyzed, they will use it to create the most useful pressure relief pattern, then return to test that pattern against conventional pressure relief methods, such as lifting every 15 minutes or reclining in the wheelchair.
Two of the days in the Cleveland laboratory were dedicated to analyzing the effects of stimulation on wheelchair propulsion and trunk stability. Most of these experiments were conducted with specialized equipment housed at the Louis Stokes Veterans Administration hospital in Cleveland and with the PI (Principal Investigator) pacing in the background.
My homework assignment before traveling up to Cleveland for this visit was to test the wheelchair propulsion pattern in the real world. As I did, my biggest complaint was the fact that the stimulation would externally rotate my knees and anything that I was carrying on my lap would fall off. Realistically, I would not use the wheelchair propulsion pattern for short distances, but for longer treks in the wheelchair. And in that situation, I am most likely carrying something on my lap. Plus, when I wheel on uneven surfaces the knees would still wobble around.
With this feedback, the therapist and engineer worked together to try to find a viable solution. They adjusted the stimulation pattern to hold my knees together but for my left side it was not so simple. To help solve this problem, we adjusted the stimulation between the left glut max and the left post adductor. The engineer would adjust the stimulation pattern, turn on the system and we would observe which muscle would win the battle. If the glut max won, then the knee would rotate out. If the post adductor won, then the knee would rotate in. During these tests, my knee was flipping in and out and while entertaining everyone in the room. In the end, we finally found a balance between the 2 muscle groups for a more functional wheelchair propulsion pattern.
Now that we had the pattern established, it was time to collect data. The general theory is to stimulate targeted hip and trunk muscles for a more rigid seated position while minimizing the energy lost due to the body wobbling in the wheelchair and improve the efficiency of pushing. A specialized wheel was placed onto my wheelchair to measure how hard I pushed and in which direction. Unfortunately, the wheel didn’t start up the first day and the team could not get it working. After digging into the guts of the wheel, they were able to get it operating properly but this backed up all the experiments into the next day.
There were 2 basic experiments for the wheelchair propulsion pattern. The first tested the pattern while wheeling on ramps. The team set up a room with 2 ramps; one at 10 degrees of slope and the other at 5 degrees of slope. Each ramp length was about 6 feet. For the experiment, on cue I would wheel up one of the ramps either with stimulation or without stimulation. The research team would measure the time to wheel up the ramp, the number of pushes I needed, plus the data collected from the wheel. After several trials, there was no real observable difference with and without using stimulation.
Feedback from this experiment is that the real value of the wheelchair propulsion pattern seems to be for long distances. But how can we measure the use for longer distances? This is when participants can influence research. I lead them to the ultimate test bed for a ramp with distance, slope and resistance. At the VA hospital, there is a very long incline with various slopes from the parking garage to the main hospital. Plus, this long incline is carpeted making it more difficult to propel a wheelchair. Off we go to the incline, which is the main route between the parking garage and the hospital. We attempted to run the experiments while keeping the normal traffic from interfering, so the general hospital patrons must have thought we were crazy. But in the end, it worked. We tested the incline with and without stimulation and observed that the duration and intensity of the pushes were reduced with stimulation. I suspect testing like this will surface again on my next visit.
The other experiment involved using a motion capture system in the Gait Laboratory. This camera system is the same one used by the motion picture industry to develop animation and computer generated special effects. But for this application, the research team uses the system to analyze movement while propelling a wheelchair with and without stimulation. They placed small reflective balls on key areas of the body such as the shoulder, hips and elbows to name a few. When I was in the viewing area of the cameras, I could wave my arms like a ghost and a “connect the dots” image of the reflective balls would move in real-time on the computer screen. The stresses and strains on my shoulder can be computed from positions of my arms and trunk together with the data from the wheels. The question is whether stimulation affects both how I push the wheelchair and ultimately the wear and tear on my shoulders.
The experiment was conducted by having me propel the wheelchair at a constant speed across the floor of the laboratory; some with stimulation and some without stimulation. Two engineers had the computer systems connected to the cameras and we had my mom on the video camera. One engineer would call “ready” and the other “set”. Then my mom would call “go”. We repeated this sequence a total of 20 times. The two videos below show the experiments with and without stimulation. It is difficult to tell the difference by eye, but focus on my posture in the wheelchair.
The final set of experiments explored the effects of stimulation on my trunk stability. The first experiment was a rowing test. A bar was attached to the dynamometer to simulate a rowing exercise machine. The dynamometer kept the tension and speed of movement at a constant rate and the researchers would measure the force I exerted as I pulled the bar toward me. This movement would be done with and without stimulation 10 times each. From personal observation, without stimulation I would arch my back and strain my lower back. With stimulation, the movement was much easier with a straight posture.
The second trunk stability test gathered data about my ability to extend my hips and back to press into an upright position. The test was conducted in 3 different angles of the trunk; upright, 15 degrees bent forward and 30 degrees bent forward. For each angle position, they would test the baseline (me not moving), pushing back with no stimulation, pushing back only using stimulation and pushing back with both my effort and stimulation. The pushing back would be for 5 seconds followed by 25 seconds of rest. The engineer kept time, monitored the computer screens and attempted to keep me on track.
As we progressed through this experiment, the upright position was not that bad. But as we moved to the 15 degrees and the 30 degrees, it became progressively more difficult. At some point, my face was completely red and I needed to take a break. What we will do for research. The saving grace during this test was the little image on the computer screen.
Although the system is called the Standing System, there are many other applications that can be derived from the various implanted electrodes. These experimental patterns need to be proven with data and analysis. As users, we can provide feedback of the impact, potential uses in the real world and provide observations. In the end, medical research needs data to prove comparative effectiveness before it can be a viable option in the health system. With that in mind, these experiments are a necessity to allow people to get access to the technology.
Part II of this journal entry will explore the conversion from standing with a walker to standing with crutches.
March Lab Visit Part II: Transition to Crutches
The ability to stand with crutches was one of my original goals and reasons for getting the upgraded standing system. I have been standing with the 8-channel implanted system for 12 years. This new goal is a lofty one for a quadriplegic.
The first crutch standing attempts took place over the 5-day stretch in the lab. We squeezed in training with the crutches around various other experiments that required special equipment, the scheduling of other researchers and alternative lab time.
After 3 months of standing with the upgraded standing system, it was time to set the walker aside and begin standing with the crutches. The transition is not easy. Just like taking the training wheels off a bike, converting to crutches is an odd feeling at first. While preparing to stand, I no longer have the comfort of a walker as a security box around me and I need to trust the implanted system.
The first day in the lab, it was time to put the new standing system to the test. To make the transition easier, I transferred to a mat table and the therapist raised the level up to help make the sit-to-stand transition easier. The first attempts would be with gaiter-aid crutches; which are Canadian crutches with a four prong foot base. With 2 spotters (one being the therapist). I activated the system, 1-2-3 and up. But I needed help and lots of it. Using the gaiter-aids proved to be more difficult than I expected. We tried a few more standing attempts, but no success.
The therapist observed that the gaiter-aids may not be the right tool. She took the crutches and maneuvered herself around the lab using the gaiter-aids. Not impressed by the stability of the gaiter-aides, the therapist went back into the equipment closet and returned with a set of Lofstrand (or forearm) crutches with a standard single point base. “Let’s try these”. With a few more standing attempts, there was some improvement. It still was not as smooth of a stand, as what I am accustomed to with a walker. In the typical research team fashion, we began to troubleshoot and dissect the problem to find solutions.
One issue is my ability to activate the system. For years, I have been able to take my hand off the walker to press the buttons on the UECU to activate and deactivate the system. With crutches, it is much more difficult to press the button and hold onto the crutches at the same time. There is a technical solution for this. The engineer steps out of the lab to his locker of equipment and returns with a finger switch. This is a long coil that connects to the UECU. On the end of the coil is a ring to wear on the finger. Attached to this ring is a control panel of smaller buttons for the UECU. I can wear the ring and activate the system with my finger while keeping my hands on the crutches. To properly accommodate me, the engineer turns into a jeweler and fits me properly with the optimum ring size and adjusts the finger switch to fit me.
The most compelling discovery I made was that standing with the crutches reveals my physical challenges. These challenges do not surface or they are easy to compensate for when using a walker. In other words, while using a walker I can easily “suck it up”. But standing with crutches “sucking it up” is not so easy. In the end, this became an engineering challenge to tweak the system to get to that ‘perfect stand’.
What did we discover? For quite some time, when using a walker and using a swing-to-gait, my right leg would kick forward. While trying to solve this problem, we have been focusing on muscles on the right side of the body. We adjusted about every electrode to try to find the culprit with no success. While working with crutches, the therapist observed that my left hip was rotating back and this was an epiphany toward finding a solution. The culprit was not a muscle on the right side, but it was my left gluteus maximus muscle. This muscle was contracting and rotating my left hip back and in turn swinging my right leg forward. We gave the box to the engineer to program the UECU to lower the left glut muscle. Problem solved.
The right leg issue was not the only discrepancy that surfaced while using the crutches. Transitioning from sit-to-stand was not a smooth movement. We had several sit-to-stand practices, and I needed a double rock of the upper body to get enough momentum to stand up; I labeled it the ‘double umph’. The engineer offered a little technical help with this too. He programmed into the UECU a booster shot for the stand. This gives a stronger muscle contraction during the sit-to-stand transition. Technically, what he programmed was an increase of the frequency to 30 hertz for 10 seconds and then decreasing it to 20 hertz for the remainder of the stand. Using this booster shot, put the ‘double umph’ to rest and then I could just concentrate on one good transition from sit to stand.
The troubleshooting is not over yet. With the booster shot, my left foot would externally rotate. When I stand with the walker, this did not happen. While standing with the crutches, it would surface. We took the team back to the lab mat to troubleshoot and to find the muscle being the culprit of this movement. It ended up being the left hamstring. After many trials and adjustments to the pulse width for this muscle, we found a good setting to allow a stable stand and eliminate the left foot external rotation.
On a Friday afternoon, near the end of the day, we did the final round of standing. In position at the edge of the lab mat and with the crutches in place, I clicked the go button to stand. 1-2-3-stand. Success! A smooth transition from sit-to-stand with no quirky muscle recruitment. ‘Ok, let’s sit and do that again to make sure it wasn’t a mistake or a fluke.’ Then, 20 seconds of rest, then into position. ‘Everyone ready? Go’. 1-2-3-stand. Again, success. The therapist then lowered the mat to the same level of my wheelchair. Let’s try it again. It worked.
Are the stands perfect at this point? No. Am I independent using the crutches? No. So, the crutches stayed in the lab while I return to Florida. In a short time, I will travel back to the lab for more training and experiments. We haven’t met the goal yet, but we made great progress in 5 days. Further investment of blood, sweat and tears and we should be on track to achieving our goal.
How to Count: April Visit Part 1
1 ha ha ha. 2 ha ha ha. 3 ha ha ha. 4 ha ha ha. Taking inspiration from our purple friend from Sesame Street, Count von Count, this most recent visit to the Cleveland lab focused on learning how to count to 4.
Actually, the goal was to stand out of my own wheelchair and to do so unassisted, otherwise labeled by the therapists as ‘hands free standing’ – meaning their hands were free, mine were on the crutches. Timing is everything to achieve this goal. If the count is late, my legs and hips activate before my upper body is ready and I am pushed back into the chair. If the count is early, then the first part of getting up is completely reliant on my arm strength. For years, I’ve been standing with the walker and have gotten lazy with the timing. Nearly 9 years ago, Alan Alda interviewed me for an episode of Scientific American Frontiers. In that episode while relatively new to standing, I had remarked about the critical nature of counting to 3. The Count surfaces again.
The emphasis was on training for standing. To start off, we did a little more tweaking. This time the engineer decreased the stimulation ramp up time from 3 seconds to 1 second. This seemed to help with the sit-to-stand from the therapy mat at both a high level and at the level of my wheelchair height. So, the next move is to stand out of my wheelchair. But we had some situational challenges.
Achieving a good stand is reliant on getting your shoulders over your knees and your feet positioned under you. With my rigid wheelchair, the footplate is the obstacle for proper foot placement. After a little inspection, we found that the footplate is not welded to the frame of the wheelchair, but instead a removable component. We break out the tools and Voila! Proper foot placement.
Sit-to-stand should be perfect now, right? With the change in the ramp time down to 1 second and the need to learn how to count, the difference in ramp time triggered a flexion spasm in my hip. When I tried to stand from the wheelchair, my hips were flexed and I was unable to straighten my torso. The therapists call this my “old lady stand”. What we found is that this spasm went away after the muscle was stimulated for a little while. Our tweaking solution: create a new ‘warm up’ pattern to stimulate the muscle while still seated and to work out the spasm.
Since all of the electrodes are implanted above the knee, I do not have any muscle movement or contractions to stabilize the calf, ankle and foot. For this, I need to wear ankle foot orthoses (AFOs). These are braces made out of molded plastic and Velcro that fit into shoes. The pair that I have been using is 12 years old. The Velcro has been replaced several times and they have been exposed to their share of Florida sun, sunscreen and salt water. It was time to get fitted for a new pair, so we had an appointment to meet with the prosthetist. He took the old pair and placed them up on the counter. Over the years, the old AFOs have changed form and now the bottom of the brace does not lie flat on the ground, definitely time for new ones.
The process of getting fitted is much like getting a cast for a broken bone. The prosthetist marks the skin for pressure points and slips on a sock-like material over the calf and foot. He then wets a roll of fiberglass and rolls it around the material. (Yes, I asked. It is not the same fiberglass to fix a boat) After taking a short while for the fiberglass to set, he then cuts the cast off. He will use the cast to mold a new set of AFOs and they should be ready for my next visit.
With the tweaking done and appointments completed, it is back to the lab to get down to business, learning how to count. I start standing out of the wheelchair but it is not as easy as it seems. The placement of the crutches has a big influence on the success. We tried many placement options: crutches far forward or far back, crutches in close or our far. It took many trials to find the right placement. If they are too far forward, I don’t have the leverage to push up. If they are too far back, my torso falls forward on the sit-to-stand process. Reminiscent of Goldilocks, we finally find the position that is ‘just right’.
Now, it is all practice. In one day, we would do 20-40 sit-to-stands. Doesn’t seem like much? Just try it. Stand out of a chair 20 times in a row. You will feel it. But with practice, came skill. The number of ‘bad’ stands started to fade and the ‘good’ stands started to dominate.
After 4 days of practice, the last day in the lab was the final exam to see if I was independent enough to take the crutches home with me. To pass the final exam, I had to ‘impress’ the therapist and prove with confidence that I can be safe using the crutches. It was all about ‘hands free standing’. This is where the therapists are hovering but they provide no assistance while I use the system to stand. After several practice stands, I was ready for hands free standing. With a crowd around, I choked. During the final exam, the ‘bad’ stands won.
In the end, I was released to bring the crutches home with me for the next month to practice with restrictions. I will only use the crutches to practice sit to stand and I can only use the crutches if I have Tim assisting me. Yes! I may have choked on the exam, but in the end, this is what we made big strides on this visit and I’m going home with the crutches. To make sure that I comply with these restrictions, my mom packaged up the crutches so I would not use them before Tim gets home.
But let’s get to the real reason I traveled up to the Cleveland lab: to learn how to count. Just like practicing a dance routine, counting s everything. 1-2-3-4, 1-2-3-4. But as the routine becomes second nature, the counting fades and the moves become more natural. Learning how to stand using crutches is a skill to be refined only through proper technique and practice.
Alternative Patterns: April Visit Part 2
Aside from all the stand training conducted during the April visit to the lab, the researchers stayed true to form including several lab experiments. Here is a review of the various experiments and what we discovered.
Again, each morning I spend 30-60 minutes on the dynamometer for testing of the cuff electrodes around the femoral nerve to control the quad muscle group. This is all still data collection.
We also did some testing of the patterns for trunk stability, and particularly wheelchair propulsion pattern. This pattern stimulates the quadratus lumborum, erector spinae, gluteus maximus and the posterior adductors. Again, I got my workout but this time I pulled in the research team with me. This experiment entailed 6-minute tests of propelling the wheelchair around a course. Previously, we conducted this experiment in the patient ward of the VA hospital. The patient ward proved to be crowded with unpredictable obstacles. This time, we moved the course to a construction area of the hospital, so our only obstacles were the construction workers (and we did almost run a few of them over). For each 6-minute experiment, I propelled my wheelchair with one member of the research team running ahead of me to keep the track clear while two members ran behind me. During each experiment, my mom remained seated and counted the laps while the Smart Wheel on my chair collected data.
Between each experiment, we were allotted a 5 minute break. During one of our breaks, a supervisor from the construction team, introduced himself and asked “So, what are you guys doing here?” Before any member of the research team could respond, I chimed in with, ”Oh, we are conducting an obesity study and have these subjects run around a course to see their progress.” The therapist spoke up while pointing at a tall, thin engineer, “yeah, he has lost at least 300 lbs.” We had the supervisor believing us for the moment but we broke down and told him about the wheelchair propulsion testing.
Discovering new ways to use the programmable patterns is a staple of this research program. As one of the experiments, we attempted to see if the trunk or the wheelchair propulsion stimulation patterns may aid transfers in and out of the wheelchair. We started by transferring onto a therapy mat at a high height (much like the height of hotel beds these days). I attempted it without stimulation and had a difficult time with the transfer. We then tried the same transfer using the trunk stability pattern, but it proved to be more difficult. Finally, we attempted the transfer again while using the wheelchair propulsion pattern. This time, it proved to be helpful.
I wasn’t sold yet. So, we increased the height of the mat and tried the experiments again. The wheelchair propulsion pattern again, proved to be most beneficial. Below is video showing a transfer without stimulation and one with stimulation.
Transfer Without Stim
Transfer With Stim
The true test is taking the patterns out into the real world. For this visit, I stayed in Cleveland over a weekend and was staying in a hotel nestled in a business park which was nearly abandoned over the weekend. Still not sold on the wheelchair propulsion pattern helping with transfers, I attempted several times to transfer in and out of the hotel bed which was a typical very high bed. For the previous nights, I had been struggling to transfer into the bed each evening. This time, I attempted the daily routine using the stimulation. It proved to convert a difficult task into a piece of cake.
Still trying to understand the value of the wheelchair propulsion pattern, I took advantage of the abandoned parking garage. Starting on the ground level, I wheeled progressively up the floors of the parking garage. For each floor, I would attempt one with stimulation and one without stimulation until I reached the top. For me, the long inclines were much easier using the wheelchair propulsion programs. I was not progressing faster, but the effort that I needed to exert was greatly reduced, particularly the stress on my shoulders, and I could wheel up the long incline without taking a break.
Now that I’ve proven to myself that the pattern is valuable, we will see how I can integrate the pattern into every day life.
What Does Arm Wrestling Have To Do With Research?
We have progressed along enough in this research to get down to 3 main testing areas: cuff electrodes, trunk stability and standing training with crutches. In the name of research, the team typically designs experiments and recruits participants, like me, to work through the experimental process. As a participant, I give them my feedback during the experiments and also try to relate the application to the ‘real world’.
This lab visit in May is no different. The first day in Cleveland, I was back on the dynamometer for more testing of the cuff electrodes. In fact, every morning was dedicated to testing of various oscillation patterns. The data gathered here will help determine the most efficient pattern uses of the 4-channel cuff electrodes implanted around the femoral nerve. For most of the week, each morning was focused on fatigue testing which includes stimulation of the quadriceps for a duration of 30 minutes for each leg. With fatigue testing, we needed a rest period to allow the muscles to recover. We all have our morning routines. Some of us like to exercise, others read the paper, but my routine, when in Cleveland, has become coffee on the dynamometer.
Aside from this routine, there are also more sporadic experiments by which each lab visit is greeted with another barrage of experiments. Trunk stability has been the latest hot topic. One afternoon was dedicated to testing the trunk stability in the FES Motion Laboratory at the Louis Stokes VA hospital. Away in the basement of the hospital is a lab dedicated to motion testing. One engineer is the expert with the motion analysis system. This system is similar to that used in the motion picture production, particularly for animation.
For this experiment, they had a therapy mat in the middle of the room and to one side are three strings of beads with reflective balls hanging at calculated intervals. To set up my body, the research team mounted reflective balls on several of my upper body. The movement of the reflector balls is captured by the cameras, transmitted to the computer system and recorded as data points.
For this experiment, I perched on the edge of the therapy mat facing the ceiling strings. At random, I was instructed to perform a reaching movement; some with an empty box, some with a box of rocks, some with stimulation and some without stimulation. The research therapist was seated adjacent to me on the official therapist square rolling stool. She was there monitoring my movements. The difference between reaching without stimulation compared to with stimulation is pretty compelling. We noticed that with stimulation, I was able to reach further but was fishing to the stability point.
After one set of experiments, we changed the trunk stability pattern to include the posterior adductors. This brought the knees together. A small change to the stimulation pattern dramatically changed my reaching ability and trunk stability.
After this change to the pattern, we continued with the remaining tests and I kept the new trunk stability pattern for ‘real world’ use.
Speaking of ‘real world’ uses, the FES laboratory does not always offer true ‘real world’ applications. But on occasion, it can. One morning after spending my allotted 2 hours on the dynamometer, we were hanging out in the lab while allowing my quadriceps to rest before beginning transfer training. The topic of arm wrestling came up and as it turns out a member of the research team is quite the arm wrestler. She, yes she, is a registered nurse working for several research programs. Apparently, she has been unbeatable with the FES Center team for those brave enough to arm wrestle her.
In the name of research, we decided to test the trunk stability stimulation pattern in a ‘real world’ application. She was to arm wrestle me while I was using the trunk stability stimulation. Yes, we had a nurse arm wrestling a quadriplegic, but it was in the name of research. We tried one trial without stimulation and she beat me. Then, I turned on the stimulation to my trunk pattern electrodes and wrestled again. Did I win? Well, no but I put up a good fight.
It is amazing what we will do for research. Sometimes, it can be really tedious but on other occasions the experiments can be quite entertaining. In the end, it is all in the name of research.
No Respect for the Posterior Adductor
Who would think of the posterior adductor muscles as a significant muscle group? Over the past several months, I have been focusing on the quadriceps, the gluts or the quadratus. But the posterior adductors? They are nice to have but how much do they really help. They always seemed to me as a nice addition for balance but I could live without them, right? No way! It became apparent during this last visit to the Cleveland FES Center laboratory, the posterior adductors (PA) play an important role in so many of the stimulation patterns. (For those anatomically challenged, PA are the muscles on the inside of the thigh)
To be true, they surfaced during my visit in April with the wheelchair propulsion pattern. My biggest complaint about the original stimulation pattern for wheelchair propulsion was that my thighs were externally rotated and I couldn’t carry anything on my lap. The research team added PA stimulation to the pattern. This pulled my knees together and made it easier to fill my lap with stuff for any distance wheeling.
The PA became the star for the lab visit in May. During the trunk stability testing in the FES Motion Study lab (see the video in the previous journal posting), we added the PA to the trunk functional stimulation pattern. Just the addition of these muscles added a volume of stability to the trunk pattern. Again, it brought my knees together and fulfilled a needed void to create a solid base for reaching. PA has now become a permanent staple to the menu of my trunk stimulation pattern. But, the most noticeable impact was when we were tweaking the standing pattern.
During the May visit, we had many hours of tweaking the standing pattern and the technique for sit-to-stand. When I first arrived in the lab for stand training, the majority of my stands were less than perfect. In fact on the first day of training, I had more ‘bad’ stands than ‘good’ ones. It was bit discouraging for me. For a few standing attempts, I would twist my hips on the way up. On other tries, I would slide to the right. Yet on others, I would point my left toe and flex on my right heel. Between the twists, slides and foot movement, I looked like I was ready to join ‘Dancing with the Stars’.
Tackling this issue, the research team had a tweaking option that might eliminate my dance routine, but it would take at least 2 hours of programming. Essentially, they changed the stimulation sequence. In simple terms, during the ramp up sequence for standing, they stimulate the hip extensor muscles prior to stimulating the quadriceps. After waiting for the new pattern, the first stand put a kabbash on the old sit-to-stand technique and my sit-to-stand become smoother.
But we were not done tweaking the standing pattern, yet. An observation that I brought back to the lab was how I set up to stand with the crutches. Since I am a low level quadriplegic, I do not have any control of my trunk muscles. When I set up to stand with the crutches, I place my feet under my knees and scoot to the end of the wheelchair seat cushion. At the edge, I have a hard time sitting unsupported. To compensate for this, I have been turning on my back electrodes while sitting on the edge and setting up the crutches. Then I turn off the back stimulation and switch to the standing pattern. The therapist observed that with the back stimulation turned on, it is easier for me to get my shoulders over my knees for the sit-to-stand performance. Back to the programming board goes the engineer with my UECU.
The engineer did his magic. He gave me a new standing pattern. With one click of ‘go’ my back electrodes engage and with the second click the system goes directly into the standing pattern.
This is all a new pattern for standing and, yes, we had to learn how to count all over again. I had to go back to Sesame Street and have more time with Count von Count. But to our surprise, the PA came to my rescue. With this new pattern, the stimulation begins and as soon as the PA stimulation is on, my knees come together and it is time to make the transition from sit to stand. Like Dorothy from the Wizard of Oz clicking her heels together, I now click my knees together to stand up. I guess, I need a new pair of red sneakers.
With this new standing pattern and the correct timing, getting up using crutches is almost effortless. I can now rely on the stimulation rather than my brute arm strength. (I hope that doesn’t negatively impact my arm wrestling ability.) My sit to stand is still not perfect, but I am comfortable being independent and can now take more time to practice.
Trunk Reaching Without Stim
As I fly back to Florida reflecting on the last visit to the laboratory, I have a new appreciation for the posterior adductor muscles. It is an important muscle that gets little respect.
Prove the technology in the real world. That is a duty of a research participant. With the world becoming a smaller place, traveling aboard is not outside the realm of this duty. As I return from Weymouth, UK after competing in the Sail for Gold Regatta, I’m reflecting on the use of the system during my first travels outside North America with the new implanted system.
During my last visit to the lab in preparation for my upcoming international travel, I asked the technical team how the system may be recharged abroad. I received a call from the technical lab manager (who also happens to be a sailor) advising me to use a voltage converter and to, as always, never use the system while the battery is recharging. As a compliant participant, I followed his orders.
In Weymouth, UK (on the southwest shore of the UK), our team rented a condo with a spectacular view of the racing area and the National Sailing Academy.
As we settled in for a week of racing, I needed to recharge the system after a long flight (more on that later). Much like the Dry Bones children’s song,
Oh dem plugs, dem plugs
the battery charger is connected to the plug adapter,
the plug adapter is connected to the voltage converter,
the voltage converter is connected to UK electrical adapter, and
the UK electrical adapter is connected to the wall unit,
Oh how scary it can be.
The moment of truth, I flicked the power switch on the battery charger to the ‘On’ position. No lights, no power. My heart sank. Immediately, thoughts of how I could manage for 10 days without using the implanted system and taking stock of the remaining auxiliary battery power filled my head. Ok, calm down and try to solve this problem. I re-routed the electrical connections from the battery charger box to the wall unit. Next to the wall unit was a small breaker switch that was off. I flicked it to ‘on’ and with a slight delay, the power turned to the charger unit. I’m back in business.
Aside from my daily standing routine, I put the system to the test using alternative functional patterns programmed by the research team. The two most used patterns were the Glut Shift pattern and the Wheelchair pattern. The flight duration between Orlando, FL and London, UK is nearly 8 hours. As a person with a mobility impairment, I sit in the airline seat for the full 8 hours. With the exception of a few airplane types, there are no options to move around on the long flights; not even to use the restroom. Sitting in the same position for that duration is a true pressure sore risk. During this long flight, I used the Glut Shift pattern to provide much needed relief. This pattern stimulates the glut max, hamstrings and the post adductors alternating between the right and left sides. The stimulation helps to increase blood flow and muscle contraction to the critical areas that are suspect of pressure sores. After using it for this long flight, the batteries, including the auxiliary batteries were nearly dead.
The other pattern that I used frequently during this trip was the Wheelchair propulsion pattern. In the lab, we were able to discover that this pattern will not increase propulsion speed but it dramatically decreases the effort that I exert to propel my wheelchair. The pattern stimulated the glut max, glut medius, post adductors, hamstrings, erector spinae and quadradus lumborum. The combination makes the body more solid in the wheelchair seat.
As mentioned previously, our team rented a condo while in Weymouth. The condo was approximately ½ mile from the sailing venue and it was on a small hill along the waterfront. The daily trek to the sailing center had a few inclines and descends along the waterfront footpath. On my first day, I attempted the trek with no stimulation. I learned my lesson and did not do that again. Every morning, I would listen to the song of the day, turn the wheelchair propulsion pattern on and proceed along my path to the sailing center. After sailing each day, I would reverse the process. I could make it all the way back to the condo parking lot, but there was one hill where I needed assistance. The final incline was so high that regardless of the stimulation, it was very difficult to propel up the hill.
On this trip aboard, the test patterns were pushed to their limits in the real world. To me, they have proven their value as a user of the implanted system. The system provided much needed pressure relief during a very long flight and it provided the needed stability to propel my wheelchair on my ½ mile daily trek. I’m sure other users will have different experiences, but for me the patterns have proven themselves in the real world.
Paying the Consequences
After returning from the UK, I was pretty excited about my real world experiences with the new patterns programmed into the system. The Wheelchair Propulsion pattern made it easier to wheel between the condo and the sailing venue. The Glut Shift pattern helped reduce the pressure while sitting in an airline seat for nearly 8 hours. And the Trunk Control pattern aided my daily functions in a condo that was not quite wheelchair accessible.
That is all great. But each of those patterns excludes one important muscle group, the quadriceps. I failed to recognize it earlier and after returning home, I paid the consequences. This issue did not surface until I was back home and returned to standing with the crutches.
You see, during competition and even the few days leading into it, there is not much time for activities away from sailing. We typically spend five hours on the water with at least one hour on either end for boat work; add on weather briefings, coach’s reviews, an occasional protest, dinner, a shower and I’m done for the day. The exception is a weather delay; and we all know how reliable that is! In fact, I’ve been caught sleeping and exercising with the system after being on the water all day. Unfortunately, there is not much time for anything else.
Standing is one of the few patterns that stimulate the quadriceps. This is a critical muscle group for standing. Quads are the powerhouse to move from the seated to the standing position. They are also the first to fatigue and demand a rest. I get lazy standing with the walker; since I can rely more on my own arm strength to get me up. On this last trip to the UK, Tim was not with me so I brought the walker for standing. Yes, I was lazy and had little standing time.
When I returned home to begin standing with crutches again, my quads just wouldn’t get me up. Back to the gym; actually, back to weight-lifting. With the need to strengthen the quad muscles, I started a daily routine of leg lifts with ankle weights. Beginning with 5 pounds, I gradually built up to 10 pounds with 3 sets of 10 lifts. About a week later, I had the strength to stand using the crutches. It is amazing how quickly the muscles weaken when they are not used.
As I prepare to return to the UK for a second round of sailing competition (a.k.a. regatta) at the Disabled Sailing World Championship, I am more aware of the consequences to pay if I slack off with standing. Plus, this time I’ll have Tim with me and he definitely will not let me be lazy.
Apply Test Patterns – Cleveland Lab Visit – Cuff Electrodes
After traveling with the U.S. Disabled Sailing team to Great Britain for competition over the last two months, I paid a much needed visit to the FES lab in Cleveland. This time was an opportunity to use the new implanted system, along with various functional patterns, to see how they can benefit life for a person living with a spinal cord injury. Aside from standing, while traveling abroad I found the trunk control, wheelchair propulsion and pressure sore prevention patterns to be incredibly useful.
Now it’s time to get back in the lab and round out the various research studies included in the overall clinical trial that I joined almost a year ago. The visit consisted of 5 days in the lab divided by a weekend in Cleveland. The activities over the course of the 5-day visit can be segmented into three categories: cuff electrode experiments, trunk control testing and stand and transfer training. The next few entries will illustrate these experiences and how they relate to the research and development of this neural prosthetic device.
Job 1 is Cuff Electrodes. Reflecting on earlier entries, the cuff electrode is a small spiral consisting of 4 channel contacts. Each channel contact may be programmed independently. This device is surgically implanted and hugs the fermoral nerve to control the muscles in the quadriceps. This type of electrode has been implanted into only a few participants in the standing program. The research team is trying to understand how this electrode design improves the use of the system to control the complex group of muscles comprising the commonly know thigh. The electrode is targeting 3 of the 4 main muscles in the quad group controlled by the femoral nerve: the vastus lateralis, vastus intermedius and the vastus medialis.
One research project studies how oscillating patterns between the 4 channels in each cuff electrode will delay fatigue and provide longer standing durations. The current standing pattern stimulates the quadricep muscles to a full contraction with no resting times while standing. As the powerhouse of the human leg, this muscle group plays a critical role in going from sit to stand. It is also typically the first muscle to fatigue; requiring the user to sit and rest the muscle. In theory, by introducing an oscillation pattern to the stimulation, the system will allow rest time for muscles thus providing longer standing durations. So how does this apply to the standing system?
Over the course of this year, I have spent countless hours on the dynanometer to gather data and guide the engineers who are designing the oscillation patterns. After some final testing, it was time to try the patterns in actual standing. We first attempted to stand with the oscillation patterns with no data gathering equipment but simply with a walker and the research therapist. I would go from sit to stand using my typical standing pattern. After I settled into a solid stance, we tested the each of the oscillation patterns. After observing how the patterns impacted the quads we stopped the system to allow me to sit and discuss the experience. With this information in hand, it’s back for more dynanometer work.
Now, it was time to gather data while using the standing system that includes the oscillation patterns. In the lab, there are a set of parallel bars and force plates on the floor. Both are wired to collect data while standing to evaluate the weight distribution between my arms and my legs. The test method consists of standing with the oscillation pattern for one minute or until the legs fatigue; whichever is longer. With the therapist guarding my knees and the engineer holding the external control unit with the experimental patterns, I stand inside the parallel bars. Each stand was only for just about a minute, but long enough to gather the data the research team needs.
Back to the drawing board to understand how the cuff electrodes used in the standing system can be optimized for my particular nerves and muscles. The research team needs more time and information to continue to explore this new concept. It’s an incremental learning process that requires patience and the ability to deal with unexpected results. That’s the nature of research. It’s important to remember that we learn something new that moves us forward with every experiment regardless of the outcome.
Entertainment at the VA Hospital – Cleveland Lab visit – Trunk Control
Standing is a grand gesture; the ability to escape the wheelchair. However, there are other features of the implanted system that can also provide valuable function that are not as glamorous and are overlooked when introduced to the system. As person with a high level spinal cord injury, I lack voluntary control of the core or trunk muscles. Gaining function of these muscles will not only help with seated posture but use of the upper body to improve daily activities in a wheelchair.
As a recipient of the implanted neural prosthesis, I have also been eligible to participate in a research program to improve seated posture and trunk control. The research team is investigating the value of using selected electrodes of my standing system that control my hip and spine muscles for trunk stability. Over the past several months, the team has been conducting a variety of experiments to collect data on how stimulating these muscles can help improve the function of someone while they’re sitting.
The first functional experiment was reaching ability with and without stimulation of the trunk. Here, we used the Motion Study Laboratory at the Louis Stokes VA Hospital. This lab uses motion-sensing cameras to build images of movement. It is the same camera system used by the movie production industry. With a therapy mat on center stage within a sea of cameras, the research team draped a long string of reflective beads from the ceiling representing typical low shelf and table heights above the floor. The team then strategically placed reflector balls onto my body; elbows, shoulders, sternum, and a small pole on the lumbar spine.
With the stage set, I sat on the edge of the mat and performed randomly selected tasks of reaching forward with and without stimulation and with empty or weighted boxes. For each task, the student intern would list the required task, ie. “Low target, with stimulation, weighted box” and the therapist would hand me the proper box while monitoring my movements. This went on for an hour. Yes, I got bored after the first 15 minutes. To liven it up, the therapist and I would guess what the next task sequence would be. 9 times out of 10, I would guess it wrong.
The other function to test was wheelchair propulsion. As a low level quadriplegic (C6-7 SCI), using a manual wheelchair has its challenges. However, there are many benefits to choosing a manual wheelchair over a power wheelchair for someone with my level of function. But what if stimulation can provide a means to propel my wheelchair with less effort and less energy?
Our experiments, started off by replacing my current wheelchair wheels with a data collection set. The first of four experiments was in the Motion Study Lab at the VA. To capture my motion while propelling my wheelchair, reflective balls were placed all over my body. When it was all set up, I looked pretty funny:
During this experiment, I would wheel across the “stage” at a constant pace with and without the trunk stimulation. As you can image, wheeling back and forth, back and forth, gets a little monotonous. To keep us entertained, I would play around with the images on the screens between experiments; like making swimming motions or dance moves. In the end, stimulation dramatically changed my posture in the wheelchair. With stimulation, I have a very straight and proper posture. Without stimulation, my posture is slouched or “slinky down”. We returned the reflector balls and headed out into the ‘real world’ for more experiments.
The 100-meter dash was next. The research team found a straight and level stretch in the hospital. The test was to propel my wheelchair as fast as I could for 100 meters with and without stimulation. A student intern was up the course to keep the path clear and my mom was staged further up the course to do the same.
Over the course of the experiments, there were groups of nurses and therapists that were near misses as I flew passed them. But the best was during one experiment, when a staff member parked a lunch cart in the middle of the hallway and put the break on. Getting closer and closer to the cart, it was almost inevitable that I would hit it. My mom attempted to move it but couldn’t get the break disengaged. Calling for help, she summoned the student intern who used all of his strength to push the cart aside…it was a close call avoiding Jello and soup flying all over the hallway. Speed tests done.
The final wheelchair propulsion tests were ramps. Urgh! One ramp was carpeted and has a lower slope and the other was cement with a higher slope. For both ramp tests, I propelled up the ramp with and without stimulation. The cement ramp is in the walkway to the new wing of the VA hospital. In this wing, there is minimal people traffic and the experiments were completed with little fanfare. On the other hand, the carpeted ramp is in the walkway from the parking garage to the main atrium of the hospital. Now, those experiments were much more…‘entertaining’.
As any manual wheelchair user knows, a ramp with carpeting is not an easy scenario. My mom and the intern did a great job of keeping people to one side on the ramp. The expressions from the people passing by were mixed; some perplexed, others inquisitive and some even cheered me on. During one of our resting times, the therapist was commenting about how she could beat my time. Not to pass up a dare, I popped out of my wheelchair and handed my chair over to her. “Here, go ahead. You try it.”
Armed with my wheelchair and the challenge on the table, the therapist took my wheelchair to the bottom of the ramp. She beat my time by almost half. “What! No, way. There must be error.” Second time around, she does it again. What a Wonder Woman! But it’s not over yet. The student intern, who happens to be on the CWRU swim team, chimes into the wheelchair competition. His proposal: He can beat both times using a hospital transport wheelchair; those heavy, inefficient depot wheelchairs. Convinced there is no way he can beat our times, the therapist and I take him up on this challenge. Pushing as fast as he could, the intern beat even my therapist’s time. Ouch!
After being smoked by the therapist and by the 20 year-old intern, I was crushed. Of course, I wanted to blame the technology. In the end, it was all for good fun. But the reality is that the evidence is mounting that trunk stimulation may make life as a quadriplegic using a manual wheelchair much more functional. The other reality is that I need to get back in the gym!
Troubleshooting During Cleveland Lab Visit
Trust. It’s a fragile emotion. It is hard to learn and easy to loose. I haven’t been released for independent standing with crutches by the physical therapist because of trust, and I need to earn it. The therapist needs to trust that I will be successful and safe while standing with crutches and I have not demonstrated that yet. But trust goes both ways. I need to trust that when I tape the coils to my skin and activate the standing system, it will work. Most recently, my trust of the implanted system was tested.
With this system, there are internal (or implanted) components and external components each of which need to communicate. That communication between the components is called coupling. The external coil must communicate with the internally implanted receiver. If that coupling relationship is compromised, the system does not operate properly.
The coupling problem persisted. Time to troubleshoot. I tried re-taping the coils, using different coils, adding auxiliary batteries; all the tools at my disposal as a user with no success. Then, the ‘what-ifs’ started to surface. What if the UECU is bad and they don’t have a backup from the technical lab? What if I need more power from the system but we are already near maximum capacity? What if the implanted receiver has gone bad? At one point, Tim and I no longer trusted the system for standing. But to feed my addiction to standing, Tim would spot me while standing with a walker; which was once a piece of cake for me. We were loosing trust in the system and quickly loosing my independence. Time to call in the mechanics.
During my visit to Cleveland, coupling was the first thing to troubleshoot. Calling on the consultation from the program engineer, I handed him all four coils and the UECU explaining the situation. After some testing, he came with the results. The UECU tested fine and 2 of the 4 coils are functioning on the test system.
The coils are a small component that takes a daily beating due to having tape applied and removed and due to constantly being subjected to mechanical stresses with movement of my body. Sometimes they can malfunction due to the daily use. The research program recognizes these shortcomings and is working on several ideas to improve the reliability of the coils.
The short solution is to issue new coils to me. Safety is a high priority so the team added a coupling testing pattern. Here I can connect the coil to the UECU, press a button and the system will beep if there is not a proper coupling. The engineers added an additional safety feature. If the coupling declines, it will first deactivate only some electrodes rather than all of them. Now, before taping the coils to my skin, I can test with the system to re-assure that I have the proper placement before taping them down for the day. I call it my trust building button. The issue was elevated to the technical lab for the engineers to research additional solutions.
But our troubleshooting was still upon us. Over the 12 years of using the standing system, I have been the participant with the dance moves. When I first started standing with the 8-channel system, I would get a spasm in my hips. They would shake from side to side much like the hula. Like clockwork, my first few minutes of standing would induce a hips spasm and I would hula. Over time, the spasm went away and I lost my hula move.
More recently, I have been having some difficultly getting from sit to stand with the crutches. During this most recent visit, I ask the research team to observe what was happening to help troubleshoot the issue. What they observed: As I stand up, my left toe points and my right foot flexes and kicks out. The engineer mimicked the move and labeled it the ‘Irish jig’. Yet another dance move!
Unfortunately, this dance move is not functional so the physical therapist will work her magic to help find the culprit. I transfer onto the therapy mat and we begin checking each individual muscle group. The gluteus medius is the muscle in the hip that scissors the leg out. When we tested the left gluteus medius, it almost tossed the therapist off her square stool. I guess there is a little power in that electrode. Also during this check, we discovered that the post adductor (the muscle that pulls the legs together) contraction was not strong enough to offset the contraction from the gluteus medius. Suspecting that this offset was the culprit, we turned the post adductor up to get a stronger contraction.
The culprit for the left foot planterflexion (pointing) was the hamstring. By turning it down, we can decrease the contraction to stop the spillover to the foot. It still amazes me how the intricacies of muscles work together in the human body.
With her tweaking order, the therapist gives the recommendation to the program engineer. He goes back to his office for some system programming and returns with a new program loaded into the UECU. Using the walker, we try a stand to see how the latest adjustments integrate together in the standing pattern. Press the button, activate the system and I stand out of the chair. The left toe pointing is gone and the right foot flexion is no more. With that, I lost my Irish Jig dance move.
But we discovered another consequence of our actions. While we turned up the stimulation to the post adductors, my legs were stuck together like a magnet. The contraction was so strong that the therapist couldn’t separate my feet. To go from sit to stand, the strong contraction was good but for standing and transferred the result was not favorable. The engineers tweaked the system to get the best of both.
Sit to stand is now a dream, nearly effortless. Standing with crutches is much easier and now a factor of practicing the technique and re-building my trust of the system.
With all of my knit picking of the system, we can’t loose sight of what is being accomplished. A person with paralysis who has been committed to life in a wheelchair, can now stand up under her own muscle power. That is a pretty incredible accomplishment. It’s bigger than my body.
Taking the Spring Out of My Step
The protocol of the research program is for me to stand and transfer using a walker. With the old system, I could stand with a walker but it required a lot of arm strength and I could only stand for a short period of time. Prior to receiving the upgrade, I was standing with only 5 electrodes of an 8-electrode system. One electrode was not operating and two others provided a low muscle contraction; which was not a functional contraction. After receiving the upgrade, I am back up standing and transferring with a walker. That is a piece of cake.August 29, 2011
The protocol of the research program is for me to stand and transfer using a walker. With the old system, I could stand with a walker but it required a lot of arm strength and I could only stand for a short period of time. Prior to receiving the upgrade, I was standing with only 5 electrodes of an 8-electrode system. One electrode was not operating and two others provided a low muscle contraction; which was not a functional contraction. After receiving the upgrade, I am back up standing and transferring with a walker. That is a piece of cake.
The protocol of the research program is for me to stand and transfer using a walker. With the old system, I could stand with a walker but it required a lot of arm strength and I could only stand for a short period of time. Prior to receiving the upgrade, I was standing with only 5 electrodes of an 8-electrode system. One electrode was not operating and two others provided a low muscle contraction; which was not a functional contraction. After receiving the upgrade, I am back up standing and transferring with a walker. That is a piece of cake.
Beyond the expectations of the original system design, I have been standing with crutches. During the last visit to the Cleveland laboratory, we started to experiment with transfers using crutches and the standing system. The first attempts were difficult. Once again, crutches have proven to be a more fickle ambulation tool.
This particular set of crutches are very fickle. The physical therapist was the first to observe the equipment issue. You see, the crutches that I use are loft strand crutches with a unique feature of a spring at the base. In theory it can help with propulsion and perhaps going from sit to stand. In reality, the springs were the obstacle and the source of instability. With just a few centimeters difference, I could not get the clearance off the crutches to lift my feet off the ground.
Ever resourceful, members of the team contacted the supplier of the crutches and ordered a new base without the springs. Timing was not on our side, this discovery occurred during the last day of my lab time. The new bases were shipped to my home in Florida.
Within a week, they arrived. Not one to waste any time, we opened them up, switched out the bases. With Tim’s supervision, I attempted to stand with the new equipment. The first few attempts to stand were not pretty. In fact some attempts were aborted.
After awhile, taking the spring out of my step made a big difference. Over the next several days, the results of my sit to stand attempts weighed in to be more successful independent stands than aborted attempts. I’m on the verge of finally getting the hang of this. But the true test will be to prove it to the physical therapist during my next visit to the lab.
Getting Ready for Release
The test protocols are coming to a close and soon I will be released from the program. What does getting released mean?
Getting released from a clinical trial involving an implanted device is bit unique. For a pharmaceutical (drug) trial, you just stop taking the medication, take a few surveys and then you go on your merry way. (I’ve been involved in a few drug trials). With a medical device, it is not that easy. In fact, it is much more complex. The option of taking the experimental device out, like discontinuing a medication, is ludicrous. The option to stop using the device is hard to accept and unconscionable.
But some in the industry and regulatory agencies advocate administering an implanted medical device trial like a drug trial. How can we consciously give function back to people with paralysis and then take it away in the name of science? After gaining function back at the press of a button and integrating it into your life, taking the option away again is like being spinal cord injured all over again. Some times I question if regulators, funding agencies, grant reviewers and the folks in the medical device industry understand that simple fact.
With this in mind, there is a reason I have stayed with the team working at the Cleveland FES Center. They understand the addiction to function that their participants gain. They are truly dedicated to the participants in their programs. Once I am released from the program, the frequent travel between Florida and Ohio will cease. However, the team will conduct a 6-month and a 1-year follow up. They will continue to collect data from the external control unit. Quarterly, there will be a transport case on my doormat for the data swap. If I encounter any problems, the team will continue to be available as long as there is funding for this project.
Most importantly, I can continue to use the system in my daily life. But in research, as in life, there are no guarantees. At some point in the future, the funding for this research project will evaporate. Then what? If our medical system remains the same, there is no long-term interest for anyone to have implanted medical devices from research projects. But how can commercial devices be developed if there are no pioneers willing to be research participants.
Sure, it is a risk and a personal responsibility that I willingly and knowingly undertook. It was communicated to me in no uncertain terms in the many legal documents associated with the research project. However, an implanted device is not like testing the Beta version of the latest tablet PC; where you can send it back or toss it without any real loss except some time and a few dollars.
At some point, the research community and the funding agencies of investigational implanted medical devices need to address the issue of long-term users of early stage technologies. Look at how much we have learned in just 12 months of using this device in this research program. Now, imagine what we can learn in 5 years. Or ten. As I prepare to be released, this issue resonates in the forefront of my mind. In the meantime, I’ll enjoy the use of the system and remain reassured by the dedication and support of the FES Center.
Closing of a Chapter, a Year to a Close, Last Entry
Reflecting on the progress over the passed 14 months, I’m amazed at how far we have come. In August 2010, a medical device was implanted into my body. Over the passed year, the system has been tested, tweaked and programmed. Along the way, I’ve gained a free back massage, an easier way to propel my wheelchair and the ability to stand and transfer for functional uses.
There have been countless hours in the lab and numerous email exchanges. In this journal, I’ve mentioned the scientists, the surgeons, the engineers and the therapists. But the reality is that there is an army of people working on developing this device. They are the ones that we don’t see like programmers in the technical lab, developers tweaking the equipment, students testing the experimental design, the nurses giving exceptional care and administrators managing the array of paperwork. They have ownership in this system just as much as those on the front lines who work with the participants.
There are also the hidden heroes. I’ve been fortunate to have an incredible support network. My husband, Tim, has sacrificed so much to help me from surgery recovery to functional use. He has become harder on me than the therapist, but I love it. My in-laws, who are loyal cat-sitters and help with the cleaning while I’m away. My sister and her family have hosted me in their home for the many visits to Cleveland with the countless meals and scheduling arrangements. This journal wouldn’t be complete without recognizing my Mom. What a trooper; meeting me at the airport in wee-hours of the morning, driving me between hospitals and laboratories, waiting while I have meetings and tests and pitching in when the research team needs a hand. And the cookies! The research team will forever be spoiled by my mom’s cookies. Over the course of time, she has become a member of the research team. She is a true hidden hero.
Of course, money makes the world work. The research project would not be possible without the funding agencies and institutions that believed in the concept and support this research team. Case Western Reserve University, MetroHealth Medical Center, National Institutes of Neurological Disorders and Stroke of the NIH and the Veterans Administration Rehabilitation Research and Development Service. Yes, this project is partially funded by the VA. Although, I am not a veteran, being participant is one way that I can give back to our wounded warriors living with spinal cord injuries. One day, they will benefit from the discoveries of this research.
As I reflect on this experience, it is so easy to get used to the technology and integrate it into your daily routine. After a while there is never a second thought about turning on the system for a pressure relief, pressing a button to get trunk control or having the option to stand and transfer. When I take the coils off and put the UECU on the charger, I’m reminded of the way I was left after the spinal cord injury, minus all these new bionic functions. It is a reminder to appreciate the technology.
This experience was not just a discovery of the technology but also a discovery of myself. I learned to appreciate the power of music and images catering to the importance of mental preparation. Quoting many lyrics to songs sometimes define an experience and help to describe it eloquently. The images taped to the walls of my hospital room to help overcome the post-surgical pain are now staples of the Clinical Research Unit.
I’ve learned patience for others and for myself. The time waiting to properly set-up an experiment or the time to allow the body to properly heal resonated the power of patience. The hours of repeated experiments to achieve reliability scream to find ways to keep the team (and me) entertained.
I’ve learned the process of experimentation is never straight-forward and the value of flexibility to re-design to get the best outcome is a necessity in research. I can appreciate the discovery in success but also the discovery in failure; each being a critical part of research, and any growing experience for that matter.
Even after the ‘Wow!’ factor from the initial stand has worn thin, I find that I’ve grow more demanding on the system. I expect it to work every time the system is booted up. And, it does. Daily use transforms from a nice option to a necessity in life as a quadriplegic living independently.
Music has become intertwined in this experience. Every time I draft a journal entry, themed music is in the periphery. As I’m writing this final entry, these lyrics are resonating in my ears: “This is a call to the color blind. This is an I.O.U…cause I’m bigger than my body gives me credit for…” (John Mayer) What a great way to sum up this experience. The research is more than my ability to stand using my own muscles. It is functional recovery after a spinal cord injury, even for people like me who are 10+ years post injury.
Finally, this journal can’t be closed without thanking all the readers and followers of this journey. The messages of encouragement, gracious cheers and heart-felt notes have helped me along the way. I am still amazed at even the silent readers. I hope this has helped to build an understanding of the human experience and the required commitments of clinical trials. I am not the only one to participate in the exciting world of scientific development, nor will I be the last. This is one small contribution to the evolution of technology and the progress to improve life for people living with spinal cord injury.
Thank you for the experience.