Post Stroke Hand Functions: Bilateral Movements and Electrical Stimulation Treatments

Study Overview
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Brief Summary
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The purpose of this study was to determine the effect of two amounts of treatment therapy on post stroke motor recovery in the arms. The therapy is bilateral movement training combined with electrical stimulation on the impaired limb.

Detailed Description
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Intense movement training (practice) with the affected arm after stroke has the potential to improve upper extremity (UE) function resulting from neuroplasticity changes in the motor cortex. However, the necessary and sufficient parameters of this therapy in humans have not been fully investigated. Delineation of the most efficacious and efficient therapy for promoting UE recovery post-stroke is necessary before effective clinical implementation of this therapy. The current compared the effects on motor function impairments for three bilateral movement groups involving two doses of treatment (i.e., bilateral training coupled with neuromuscular electrical stimulation) and a sham control. During the subacute recovery phase (3 - 6 months), patients who meet motor capabilities criteria will be randomly assigned to one of three groups: (a) low intensity: 90 minutes/session, 2 sessions/week 2 weeks; bilateral movement training coupled with active neuromuscular stimulation on the impaired wrist/fingers; (b) high intensity: 90 minutes/session, 4 sessions/week for 2 weeks; bilateral movement training coupled with active stimulation on the impaired wrist/finger extensors; and (c) control group (sham active stimulation). Patients' UE motor capabilities were assessed before treatment therapy began (pretest) and within the first week after the treatment therapy ended (posttest).

Official Title
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Subacute Stroke Recovery (Upper Extremity Motor Function): Bimanual Coordination Training

Conditions
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Cerebrovascular Accident, Hemiplegia

Intervention / Treatment
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* Behavioral: Bilateral movements and neuromuscular electrical stimulation
* Behavioral: Bilateral movements and neuromuscular electrical stimulation
* Behavioral: Bilateral movements and sham electrical stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: an ability to complete 10º of wrist or finger extension from a 60 - 65 º flexed position score less than a 56 on the UE subscale of the Fugl-Meyer Assessment an ability to voluntarily activate slight movements in the wrist and fingers so that the EMG activity reaches a minimal level on the microprocessor for electrical stimulation to be activated unilateral, first stroke of ischemic or hemorrhagic origin in the carotid artery distribution free of major post stroke complications able to attend therapy 2 days/week or 4 days/week for 2 weeks score at least a 16 on the Mini Mental Status Examination able to discriminate sharp from dull and light touch using traditional sensation tests. Exclusion Criteria: hemiparetic arm is insensate motor impairments from stroke on opposite side of body pre-existing neurological disorders such as Parkinson's disease, Multiple Sclerosis, or dementia Legal blindness or severe visual impairment; 5) Life expectancy less than one year Severe arthritis or orthopedic problems that limit passive ranges of motion of upper extremity (passive finger extension < 40º; passive wrist extension < 40º; passive elbow extension <40º; shoulder flexion/abduction < 80º) History of sustained alcoholism or drug abuse in the last six months Has pacemaker or other implanted device pregnant

Ages Eligible for Study
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Minimum Age: 44 Years
Maximum Age: 86 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Intensity<br>Bilateral training moving both arms coupled with neuromuscular electrical stimulation; four 90-minute sessions/week for 2 weeks. | Behavioral: Bilateral movements and neuromuscular electrical stimulation<br>* Participants practice moving their paretic arm at the same time as they move their non-paretic arm in the same movement patterns. Neuromuscular electrical stimulation triggered by the participants' own contracting muscles is provided to the paretic arm during the movements. Training period was 4 times per week for 2 weeks.<br>* Other names: functional electrical stimulation;|
| Active Comparator: Low Intensity<br>Bilateral training moving both arms coupled with neuromuscular electrical stimulation; two 90-minute sessions/week for 2 weeks. | Behavioral: Bilateral movements and neuromuscular electrical stimulation<br>* Participants practice moving both their paretic and non-paretic arms at the same time in the same movement patterns. Neuromuscular electrical stimulation triggered by the participants' own contracting muscles is provided to the paretic arm during the movements. Training period was 2 times per week for 2 weeks.<br>* Other names: functional electrical stimulation;|
| Active Comparator: Control<br>Bilateral training moving both arms coupled with sham neuromuscular electrical stimulation | Behavioral: Bilateral movements and sham electrical stimulation<br>* Participants practice moving both their paretic and non-paretic arms at the same time in the same movement patterns. Sham electrical stimulation (low level electrical stimulation that can be felt but is insufficient to trigger a muscle contraction) is provided to the paretic arm during the movement. Training period was 2 times per week for 2 weeks.<br>* Other names: functional electrical stimulation - sham;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Box and Block Test; Data Collected = Number of Blocks Moved | A 60 second timed hand/arm manipulation test in which participants reach, grasp, lift, and release a 1 x 1 block of wood. They must lift a block from one side of a box, carry it over a low barrier and release the block into the other side of the box. | Baseline/pretest; posttest given between days 17-22 (posttest days 3 -8) | 
| Fugl-Meyer Upper Extremity Motor Test | FM motor test assesses functional impairments post stroke as participants attempt various movements from daily activities. Minimum score = 0; maximum score = 66; lower scores indicate more impairments and higher scores indicate less impairments. | Baseline/pretest; posttest given between days 17-22 (posttest days 3 -8) | 
| Fractionated Reaction Time | Premotor reaction times in milliseconds were recorded for the impaired arm of each participant in the three intervention (arm) groups. Premotor reaction time represents central processes. Lower times are faster reaction times, indicating less time to initiate a movement. | Baseline/pretest; posttest given between days 17-22 (posttest days 3-8) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rehabilitation, Physical Therapy Techniques, Occupational Therapy, Upper Extremity; Motor skills