Electrical Stimulation After Botulinum Toxin Injections to the Upper Extremity

Not Applicable

Interventions: Device: Neuromuscular Electrical Stimulation
Device: Sham Electrical Stimulation

Brief Summary: 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: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Electrical Stimulation Group	Neuromuscular Electrical Stimulation	This arm will receive neuromuscular electrical stimulation to the antagonist muscles of the upper extremity.
Sham Stimulation Group	Sham Electrical Stimulation	This arm will receive sensory stimulation without muscle contraction to the antagonist muscles of the upper extremity.

Primary Outcome Measures

Name	Time	Method
Chedoke-McMaster Stroke Assessment Measure- Arm and Hand Recovery Stage	Baseline, 1 month and 6 months after injections	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.

Secondary Outcome Measures

Name	Time	Method
Action Research Arm Test	Baseline, 1 month and 6 months	Standardized measure of upper extremity function. The total score ranges from 0-57. A higher score indicates better arm function.
Modified Ashworth Scale for the Upper Extremity	Baseline, 1 month and 6 months	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.
Motor Activity Log	Baseline, 1 month and 6 months after injections	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.
Box and Block Test	Baseline, 1 month and 6 months after injections	Standardized measure of upper extremity function. The score is the number of blocks transported within one minute. A higher score indicates better arm function.
Numeric Pain Rating Scale	Baseline, 1 month and 6 months	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.

Receive instant email notifications about changes in this clinical trial

Receive instant email notifications about changes in this clinical trial