Treatments for Recovery of Hand Function in Acute Stroke Survivors

Completed

Phase 1/2 Results

Trial Description

Impaired hand function is one of the most frequently persisting consequences of stroke. The purpose of this study is to investigate whether two different types of treatment improve recovery of hand function after stroke.

Detailed Description

Loss of hand function is common after stroke. Previous research suggests that treatments that focus on movement of both hands at the same time or treatments that electrically stimulate the paretic (weak) hand muscles may help the recovery of hand function after stroke. In this study, two electrical stimulation treatments will be compared in their effectiveness in restoring hand movement and hand function. One of the treatments is stimulation only, and the other is stimulation linked to movement of the contralateral hand.
Study participants will be stroke survivors who are enrolled while they are still within their first 6 months after their stroke. After enrolling, their hand movement and function will be tested. Then they will be randomly assigned to one of the two treatments. Each treatment will last 6 weeks. The treatment will require the participant to perform specific exercises at home for a total of 2 hours every day and to come to the laboratory twice a week for study-related occupational therapy. At the end of the 6-week treatment, tests of hand movement and hand function will be repeated. The same tests will be repeated again at 1 and 3 months after the end of treatment to see if the effects of the treatment persist as time goes on. Changes in upper extremity impairment and activity limitation will be compared across treatment groups.

Conditions

Interventions

  • Neuromuscular electrical stimulator Device
    Intervention Desc: Intervention Characteristics Common to Both Groups • 6-week intervention Home "exercise", daily Exercise (at home) 2 sessions/day A "session" consists of 3 (for CCFES) or 4 (for cNMES) 15-min sets separated by 5 min rest A "set" entails hand opening, closing, and relaxing in response or synchrony to light and sound cues and according to group-specific instructions Lab "therapy", 2x/week Two 1.5-hr sessions/week, working on functional hand tasks and tracking task (if possible).
    ARM 1: Kind: Experimental
    Label: CCFES
    Description: CCFES - Contralaterally Controlled Functional Electrical Stimulation Stimulation to finger and thumb extensors and flexors only in response to and with an intensity proportional to opening and closing 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 flexor and extensor stimulation repeatedly and automatically close and open the hand without any effort or voluntary intent required by the subject. Subject instructed to relax, not attempt to assist the stimulation, and not to move the contralateral arm/hand during stimulation Therapy sessions are done without the stimulation system

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Active range of motion of finger extension (a measure of hand impairment) and Arm Motor Abilities Test (AMAT - a measure of upper limb activity limitation) These assessments will be administered on 4 occasions: at baseline, end of treatment, and follow-up assessments at 1 month and 3 months post-treatment. No
Secondary Isometric finger extension moment, finger flexor tone, finger extension tracking accuracy, upper extremity Fugl-Meyer motor assessment, the box and block test. These assessments will be administered on 4 occasions: at baseline, end of treatment, and follow-up assessments at 1 month and 3 months post-treatment. No
Primary Maximum Voluntary Finger Extension Angle (a Measure of Hand Impairment) 3 months post-treatment. No
Secondary Finger Tracking Error 3 months post-treatment. No
Secondary Box and Blocks Score 3 months post-treatment. No
Secondary Arm Motor Abilities Test 3 months post-treatment. No
Secondary Fugl-Meyer Assessment (Upper Extremity) 3 months post-treatment. No

Sponsors