Contralaterally Controlled Functional Electrical Stimulation for Hemiparetic Hand
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Stroke, Acute
- Sponsor
- MetroHealth Medical Center
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- Maximum Voluntary Finger Extension Angle (a Measure of Hand Impairment)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Investigators
Jayme Knutson
Assistant Professor, Physical Medicine and Rehabilitation
MetroHealth Medical Center
Eligibility Criteria
Inclusion Criteria
- •Age 18 to 80
- •Within 6 months of first clinical hemorrhagic or nonhemorrhagic stroke
- •Cortical or subcortical stroke
- •Unilateral upper extremity hemiparesis with severe finger extensor and flexor paresis (\<= grade 4 on Medical Research Council (MRC) scale)
- •Adequate movement of the shoulder and elbow to allow volitional positioning of the affected hand in the workspace.
- •Surface NMES of finger and thumb extensors produces functional hand opening without pain
- •Full volitional opening of the contralateral hand of the unimpaired side.
- •Able to follow 3 stage commands
- •Able to remember at least 2 of 3 items after 30 minutes
- •Able to hear and respond (by opening the less affected hand) to auditory cues issued from the stimulator?
Exclusion Criteria
- •Insensate forearm and/or hand
- •Edema of the affected forearm and/or hand
- •History of potentially fatal cardiac arrhythmias.
- •Cardiac pacemakers or any other implanted electronic systems
- •Pregnant women
- •Uncontrolled seizure disorder
- •Severely impaired cognition or comprehension
- •Uncompensated hemineglect
- •Severe depression (\>= 13 on Beck Depression Inventory Fast Screen)
- •Ipsilateral lower motor neuron lesion
Outcomes
Primary Outcomes
Maximum Voluntary Finger Extension Angle (a Measure of Hand Impairment)
Time Frame: 3 months post-treatment.
A custom-built electrogoniometer recorded the angles of the metacarpophalangeal (MP) and proximal interphalangeal (PIP) joints of the index finger simultaneously. Participants were seated with the forearm and wrist supported and stabilized in a neutral posture. From this resting postion, they were instructed to extend their fingers as fully as possible in response to a 4-sec audio cue. The MP and PIP angles were added together, providing a composite measure of degree of finger extension, where 0 degrees corresponds to full extension of the MP and PIP joints. The more negative the angle, the more flexed the finger.
Secondary Outcomes
- Finger Tracking Error(3 months post-treatment.)
- Box and Blocks Score(3 months post-treatment.)
- Arm Motor Abilities Test(3 months post-treatment.)
- Fugl-Meyer Assessment (Upper Extremity)(3 months post-treatment.)