Electrical Stimulation After Botulinum Toxin Injections to the Upper Extremity

Texas Woman's University

Status: Unknown

Conditions: Stroke

Treatments: Device: Neuromuscular Electrical Stimulation; Device: Sham Electrical Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04217187

IRB-FY2020-43

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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28 participants in 2 patient groups

Electrical Stimulation Group

Experimental group

Description:

This arm will receive neuromuscular electrical stimulation to the antagonist muscles of the upper extremity.

Treatment:

Device: Neuromuscular Electrical Stimulation

Sham Stimulation Group

Sham Comparator group

Description:

This arm will receive sensory stimulation without muscle contraction to the antagonist muscles of the upper extremity.

Treatment:

Device: Sham Electrical Stimulation