Stroke < 2 years ago

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Contralaterally Controlled FES of Arm & Hand for Subacute Stroke Rehabilitation

Background

Impaired arm and hand function is one of the most disabling and most common consequences of stroke. The Investigators have developed Contralaterally Controlled Functional Electrical Stimulation (CCFES), an innovative neuromuscular electrical stimulation (NMES) treatment for improving the recovery of hand function after stroke.


About This Study

Objective/Specific Aims:The purpose of this study is to maximize the treatment effect of CCFES by adding stimulated elbow extension. The specific aims and hypotheses are as follows:

  • Estimate the effect of Arm+Hand CCFES on upper limb motor impairment and activity limitation. Stroke survivors treated with Arm+Hand CCFES are expected to have better outcomes on upper limb impairment and activity limitation measures than those treated with dose-matched Arm+Hand Cyclic NMES.
  • Estimate the effect of adding stimulated elbow extension to Hand CCFES. Stroke survivors treated with Arm+Hand CCFES will have greater reductions in upper limb impairment and activity limitation than those treated with Hand CCFES.
  • Describe the relationship between treatment effect and time elapsed between stroke onset and start of treatment. Patients who start Arm+Hand CCFES sooner after their stroke achieve better outcomes.

The primary objective of this project is to estimate the effect of Arm+Hand Contralaterally Controlled Functional Electrical Stimulation (CCFES) reducing upper limb motor impairment and activity limitation in subacute hemiplegia. Arm+Hand CCFES therapy is intended to strengthen and improve the motor control of the proximal upper limb as well as the hand, to improve simultaneous reaching and hand opening, a functionally critical movement pattern that is often prevented by paresis and post-stroke flexor synergies. The secondary objective of this project is to evaluate the effect of adding elbow extensor stimulation to the Hand CCFES treatment.

Study Information: A sample of 108 stroke survivors with acute/subacute (≤ 6 months) upper limb hemiplegia will be randomly assigned in equal proportions to receive 12 weeks of either Arm+Hand CCFES (stimulates elbow extension and hand opening), Hand CCFES (stimulates hand opening), or Arm+Hand Cyclic NMES (stimulates elbow extension and hand opening but with pre-set timing and intensity, i.e., not intention-driven), plus lab-based therapist-guided task practice. Upper limb impairment and activity limitation will be assessed at baseline, 6, 12, 20, 28, and 36 weeks.

Detailed program information and criteria available at:
https://clinicaltrials.gov/ct2/show/NCT01688856?term=contralaterally+controlled+FES+of+arm+%26+hand&rank=1

 

Principal Investigator: Jayme Knutson, PhD
Clinical Coordinator: Peggy Maloney, RN
Contact Number: (216) 957-3558
Contact Email: mmaloney@metrohealth.org