Stroke
Conditions
Keywords
Botulinum Toxins, Spasticity, Upper Extremity, 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.
Interventions
Sensory only upper extremity electrical stimulation
DEVICENeuromuscular Electrical Stimulation
Upper extremity neuromuscular electrical stimulation
Sponsors
TIRR Memorial Hermann
Texas Woman's University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
Contacts
Primary ContactCatherine C Hay, PhD
Outcome results
None listed