Electrical Stimulation After Botulinum Toxin Injections to the Upper Extremity

January 3, 2020 updated by: Texas Woman's University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • TIRR Memorial Hermann

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 1 month and 6 months after injections

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Action Research Arm Test
Time Frame: 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.
Baseline, 1 month and 6 months
Box and Block Test
Time Frame: 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.
Baseline, 1 month and 6 months after injections
Motor Activity Log
Time Frame: 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.
Baseline, 1 month and 6 months after injections
Modified Ashworth Scale for the Upper Extremity
Time Frame: 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.
Baseline, 1 month and 6 months
Numeric Pain Rating Scale
Time Frame: 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.
Baseline, 1 month and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Texas Woman's University

Collaborators

TIRR Memorial Hermann

Investigators

  • Principal Investigator: Catherine C Hay, PhD, Texas Woman's University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

January 13, 2020

Primary Completion (ANTICIPATED)

December 31, 2021

Study Completion (ANTICIPATED)

December 31, 2021

Study Registration Dates

First Submitted

January 2, 2020

First Submitted That Met QC Criteria

January 2, 2020

First Posted (ACTUAL)

January 3, 2020

Study Record Updates

Last Update Posted (ACTUAL)

January 7, 2020

Last Update Submitted That Met QC Criteria

January 3, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB-FY2020-43

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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