Electrical Stimulation After Botulinum Toxin Injections to the Upper Extremity
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Electrical Stimulation Group This arm will receive neuromuscular electrical stimulation to the antagonist muscles of the upper extremity. |
Device: Neuromuscular Electrical Stimulation
Upper extremity neuromuscular electrical stimulation
|
| Sham Comparator: Sham Stimulation Group This arm will receive sensory stimulation without muscle contraction to the antagonist muscles of the upper extremity. |
Device: Sham Electrical Stimulation
Sensory only upper extremity electrical stimulation
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | TIRR Memorial Hermann | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- Texas Woman's University
- TIRR Memorial Hermann
Investigators
- Principal Investigator: Catherine C Hay, PhD, Texas Woman's University
Study Documents (Full-Text)
None provided.More Information
Publications
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- Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jiménez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Mackey RH, Matsushita K, Mozaffarian D, Mussolino ME, Nasir K, Neumar RW, Palaniappan L, Pandey DK, Thiagarajan RR, Reeves MJ, Ritchey M, Rodriguez CJ, Roth GA, Rosamond WD, Sasson C, Towfighi A, Tsao CW, Turner MB, Virani SS, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2017 Update: A Report From the American Heart Association. Circulation. 2017 Mar 7;135(10):e146-e603. doi: 10.1161/CIR.0000000000000485. Epub 2017 Jan 25. Review. Erratum in: Circulation. 2017 Mar 7;135(10 ):e646. Circulation. 2017 Sep 5;136(10 ):e196.
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- IRB-FY2020-43