Electrical Stimulation After Botulinum Toxin Injections to the Upper Extremity

Study Overview
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Brief Summary
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The purpose of this study is to investigate the effectiveness of using electrical stimulation to improve upper extremity function in stroke survivors who receive botulinum toxin injections for spasticity. We hypothesize that individuals who receive the electrical stimulation could demonstrate improved benefit of the botulinum toxin injections and improved functional use of their weaker upper extremity.

Detailed Description
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This is a pragmatic investigation that will utilize a two group comparison to compare electrical stimulation to a sham stimulation in individuals who are scheduled to receive botulinum toxin injections to their upper extremity for spasticity management. The electrical stimulation will be to the antagonist muscles of the injected muscles of the upper extremity and will be administered for 4 weeks post injections.

Official Title
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The Effect of Electrical Stimulation Post Botulinum Toxin Injections on Functional Use of the Hemiparetic Upper Extremity

Conditions
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Stroke

Intervention / Treatment
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* Device: Neuromuscular Electrical Stimulation
* Device: Sham Electrical Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of stroke, within first 6 months post stroke, have not previously received botulinum toxin injections for upper extremity spasticity, hemiplegic upper extremtity, able to communicate in English. Exclusion Criteria: contraindication for electrical stimulation (presence of implanted cardiac or other medical device, open wound on the wrist or hand, malignancy), fixed contracture of the elbow, wrist or hand, inability to follow simple directions, pregnancy.

Ages Eligible for Study
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Minimum Age: 18 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: Electrical Stimulation Group<br>This arm will receive neuromuscular electrical stimulation to the antagonist muscles of the upper extremity. | Device: Neuromuscular Electrical Stimulation<br>* Upper extremity neuromuscular electrical stimulation<br>|
| Sham Comparator: Sham Stimulation Group<br>This arm will receive sensory stimulation without muscle contraction to the antagonist muscles of the upper extremity. | Device: Sham Electrical Stimulation<br>* Sensory only upper extremity electrical stimulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chedoke-McMaster Stroke Assessment Measure- Arm and Hand Recovery Stage | Impairment level assessment to measure changes in active motor control and isolated movement in the upper extremity. The arm and the hand receive a separate score. The score ranges from 1 to 7. A higher score indicates better arm function. | Baseline, 1 month and 6 months after injections | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Action Research Arm Test | Standardized measure of upper extremity function. The total score ranges from 0-57. A higher score indicates better arm function. | Baseline, 1 month and 6 months | 
| Box and Block Test | Standardized measure of upper extremity function. The score is the number of blocks transported within one minute. A higher score indicates better arm function. | Baseline, 1 month and 6 months after injections | 
| Motor Activity Log | Structured interview to measure perceived function of the upper extremity during daily tasks. There is a separate score for the amount of use and how well measures. Each scale ranges from 0-5 and a higher score indicates better arm function. | Baseline, 1 month and 6 months after injections | 
| Modified Ashworth Scale for the Upper Extremity | Measure of spasticity. Each muscle group (i.e. elbow flexors) is scored from 0-4 with a 0 indicating no increase in muscle tone and a 4 indicating the affected part is rigid. A decrease in score indicates a decrease in spasticity. | Baseline, 1 month and 6 months | 
| Numeric Pain Rating Scale | Self report of current, best and worst pain of upper extremity in the past 24 hours. Scale ranges from 0-10 with a 0 indicating no pain and a 10 indicating severe pain. A decrease in score indicates less pain. | Baseline, 1 month and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Botulinum Toxins, Spasticity, Upper Extremity, Electrical Stimulation