Impaired hand function is one of the most frequently persisting consequences of stroke. The purpose of this study is to compare two different treatments -- Contralataterally Controlled Functional Electrical Stimulation (CCFES) and Cyclic Neuromuscular Electrical Stimulation (cNMES) -- for improved recovery of hand function after stroke.
Hemiparesis of the upper limb is one of the most serious and most common impairments resulting from stroke. Approximately 75% of the over 750,000 strokes that occur annually in the United States cause some degree of upper extremity paralysis. Approximately 65% of stroke survivors still cannot use their affected hand to assist with activities of daily living 6 months after their stroke. The impact of upper extremity impairments on disability and health is great, yet there are relatively few rehabilitation interventions designed to restore function to the impaired upper limb. Therefore, our long-term objective is to develop upper extremity rehabilitation therapies that are effective at restoring arm and hand function, that are applicable across a wide range of impairment severity, and that are readily implemented in the present healthcare environment.
The purpose of this study is to estimate the efficacy of Contralataterally Controlled Functional Electrical Stimulation (CCFES) in reducing upper extremity impairment and activity limitation in chronic upper extremity hemiplegia. CCFES is a rehabilitation intervention in which neuromuscular electrical stimulation (NMES) is applied to the finger and thumb extensor muscles of the paretic upper limb to open the hand. The stroke survivor controls the stimulation intensity, and consequent degree of hand opening, by modulating the degree of opening of the contralateral unimpaired hand, which is detected by an instrumented glove. Thus, volitional opening of the unaffected hand produces stimulated opening of the affected hand. The stimulation paradigm is used to assist the stroke survivor in practicing functional tasks with their affected hand. We will conduct a randomized controlled trial in which chronic stroke survivors (>6 months post-stroke) will be randomly assigned to receive 12 weeks of CCFES or cyclic NMES, an intervention that provides electrical stimulation of the hand extensors, but with preprogrammed timing and intensity. Randomization will be stratified on two levels of baseline hand impairment defined by the degree of voluntary finger extension present. Assessments of upper extremity impairment and activity limitation will be made every 3 weeks during the treatment period and every 2 months during a 6-month follow-up period.
This study is the first randomized controlled trial of CCFES in chronic upper extremity hemiplegia. Ultimately, the information learned in this study will serve to accelerate the development of treatments for reducing post-stroke disability.
- Electrical stimulator Device
Intervention Desc: • 12-week intervention Therapist-guided task practice performed twice a week in the research laboratory. (Device used for CCFES group but not for cNMES group during these sessions.) Self-administered CCFES or cNMES-mediated hand opening exercise performed 10 sessions per week at home. ARM 1: Kind: Experimental Label: CCFES Description: CCFES - Contralaterally Controlled Functional Electrical Stimulation Stimulation to finger and thumb extensors only in response to, and with an intensity proportional to, opening of the contralateral unimpaired hand. A glove instrumented with sensors and worn on the unimpaired hand detects the degree of hand opening and determines stimulation intensity. Therapy sessions are done with the subject being assisted by the CCFES system. ARM 2: Kind: Experimental Label: cNMES Description: cNMES - Cyclic NeuroMuscular Electrical Stimulation Preprogrammed cycles of finger and thumb extensor stimulation repeatedly and automatically open the hand. Subject instructed to not move the contralateral arm/hand during stimulation. Therapy sessions are done without the stimulation system.
- Allocation: Randomized
- Masking: Single Blind (Outcomes Assessor)
- Purpose: Treatment
- Endpoint: Efficacy Study
- Intervention: Parallel Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||Box and Block Test||8 times: Prior to treatment, every 3 weeks during treatment, at the end of treatment, and at 2, 4, and 6 months after completion of treatment.||No|
|Secondary||Arm Motor Abilities Test||8 times: Prior to treatment, every 3 weeks during treatment, at the end of treatment, and at 2, 4, and 6 months after completion of treatment.||No|
|Secondary||Fugl-Meyer Motor Assessment (upper limb motor impairment component)||8 times: Prior to treatment, every 3 weeks during treatment, at the end of treatment, and at 2, 4, and 6 months after completion of treatment.||No|
|Secondary||Active range of finger extension||No|
|Secondary||Finger extension tracking accuracy||No|
|Primary||Change in Box and Block Test Score at 6 Mo Post-Treatment||2 timepoints: Prior to treatment, and 6 months after completion of treatment.|
|Secondary||Change in Arm Motor Abilities Test Score at 6-Month Post-Treatment||2 timepoints: Prior to treatment, and 6 months after completion of treatment.|
|Secondary||Change in Upper Extremity Fugl-Meyer Score at 6-Months Post-Treatment||2 timepoints: Prior to treatment, and 6 months after completion of treatment.|