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Clinical Trials/NCT04217187
NCT04217187
Unknown
Not Applicable

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

Texas Woman's University1 site in 1 country28 target enrollmentJanuary 13, 2020
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Texas Woman's University
Enrollment
28
Locations
1
Primary Endpoint
Chedoke-McMaster Stroke Assessment Measure- Arm and Hand Recovery Stage
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 13, 2020
End Date
December 31, 2021
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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.

Outcomes

Primary Outcomes

Chedoke-McMaster Stroke Assessment Measure- Arm and Hand Recovery Stage

Time Frame: 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 Outcomes

  • Action Research Arm Test(Baseline, 1 month and 6 months)
  • Modified Ashworth Scale for the Upper Extremity(Baseline, 1 month and 6 months)
  • Motor Activity Log(Baseline, 1 month and 6 months after injections)
  • Box and Block Test(Baseline, 1 month and 6 months after injections)
  • Numeric Pain Rating Scale(Baseline, 1 month and 6 months)

Study Sites (1)

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