Electrical Stimulation and a Dynamic Orthosis for Stroke Recovery

May 24, 2019 updated by: The University of Texas Medical Branch, Galveston

Combining Electrical Stimulation and a Dynamic Hand Orthosis for Functional Recovery in Chronic Stroke

Objective: To explore the effectiveness of a combined neuromuscular electrical stimulation (ES) and dynamic hand orthosis (DHO) regimen used with a small group of persons with chronic stroke in improving ability to perform daily tasks. Method: Four participants with chronic stroke participated in the combined ES-DHO regimen using the affected upper extremity (UE) five times (5X) per week for 6 weeks. Outcome measures included grip strength, range of motion (ROM), and analysis of muscle activation/deactivation during release of grasp through electromyography (EMG). Ability to perform daily functional tasks was assessed using the Assessment of Motor and Process Skills (AMPS). Results: Preliminary results suggest that improvements in strength, ROM and grasp deactivation are possible with the combined ES-DHO regimen. Ability to perform daily functional tasks improved in all participants. Conclusion: Results should be interpreted cautiously due to the pilot nature of the study and small participant number. Further research in this area is warranted.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this pilot study was to explore the outcomes on performance of functional daily living tasks following a six-week combined regimen using ES and the SaeboFlex orthosis with repetitive task training (RTT) in four persons with chronic stroke. Functional outcomes were assessed before and after (pre-post design) a six-week combined treatment regimen using the DHO during RTT followed by a regimen of ES. Feasibility and logistics for translation of these preliminary results to a larger, more comprehensive controlled trial were explored. Participants donned the orthosis on the affected upper extremity with therapist assistance and performed the RTT grasp/release practice daily for 30 minutes, 5X/week for 6 weeks (30 sessions).Following completion of the grasp/release practice, ES to the finger extensor muscles was provided for 15 minutes. Goniometry to measure range of motion (ROM) at wrist and fingers, dynamometry to measure hand strength, electromyography (EMG) collection to measure muscle activation/deactivation, and AMPS testing to measure functional activity performance were performed before starting the intervention (baseline) and one day after the final training session. Gains in grip strength, 3rd metacarpophalangeal (MP) flexion, AMPS motor score, and improved deactivation of grasp were observed in all participants. Wrist extension, 3rd MP extension, AMPS process score, EMG root mean square (RMS) and time to release grasp improved in three of the four participants.These preliminary pilot results begin to suggest that gains can be made in impairment areas of strength, ROM, and the functional movement pattern of grasp release with a combined ES-DHO program in individuals with chronic stroke. Perhaps most importantly, the results may indicate that this type of training may translate to improvement in performance of daily living tasks. Completion of this work suggests that a larger trial is feasible and logistically able to be performed. The preliminary data are limited in that only four volunteers with chronic stroke were studied, so the small numbers involved restrict generalizations of effectiveness and comprehensive analysis of outcomes.

Study Type

Interventional

Enrollment (Actual)

4

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
      • Galveston, Texas, United States, 77555
        • University of Texas Medical Branch

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

20 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  1. have a diagnosis of ischemic or hemorrhagic stroke that occurred at least six months prior to date of participation;
  2. be between 20 and 85 years of age;
  3. exhibit a minimal amount of upper extremity movement (approximately 10° active wrist or digit movement);
  4. be able to communicate orally and provide informed consent; and
  5. be able to comprehend the responsibilities and procedures related to the study.

Exclusion Criteria:

(1) having one or more contraindicated conditions to receive electrical stimulation (implanted pacemaker/electronics, surgical hardware, tumors, cellulitis, open wounds, etc.)

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Pilot data
Four participants with chronic stroke participated in a 45-minute combined electrical stimulation-dynamic hand orthosis regimen using the affected upper extremity (UE) 5X/week for 6 weeks.
Other: Electrical stimulation-dynamic hand orthosis
Each participant participated in the electrical stimulation-dynamic hand orthosis regimen. Repetitive grasp/release motions were performed for 30 minutes while wearing the dynamic hand orthosis. This was followed by 15 minutes of electrical stimulation applied to forearm extensor muscles. This regimen was performed daily, 5X/week for 6 weeks.
Other Names:
  • Empi 300PV neuromuscular electrical stimulation unit
  • SaeboFlex dynamic hand orthosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline performance of functional tasks to post-intervention performance of functional tasks
Time Frame: Before and after 6-week (30 visits) electrical stimulation-dynamic hand orthosis intervention
Motor and process scores of the Assessment of Motor and Process Skills (AMPS) test
Before and after 6-week (30 visits) electrical stimulation-dynamic hand orthosis intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline grip strength to post-intervention grip strength
Time Frame: Before and after 6-week (30 visits) electrical stimulation-dynamic hand orthosis intervention
Strength of grip in affected hand measured through dynamometry
Before and after 6-week (30 visits) electrical stimulation-dynamic hand orthosis intervention
Change from baseline range of motion in wrist and metacarpal joint to post-intervention range of motion in wrist and metacarpal joint
Time Frame: Before and after 6-week (30 visits) electrical stimulation-dynamic hand orthosis intervention
Range of motion (flexion/extension)of affected wrist and 3rd metacarpal joint measured through goniometry performed by blinded evaluator
Before and after 6-week (30 visits) electrical stimulation-dynamic hand orthosis intervention
Change from baseline forearm muscle activation/deactivation to post-intervention forearm muscle activation/deactivation
Time Frame: Before and after 6-week (30 visits) electrical stimulation-dynamic hand orthosis intervention
Root mean square and time course of electromyographical (EMG) signal of extensor muscles persisting after auditory cue to release grasp
Before and after 6-week (30 visits) electrical stimulation-dynamic hand orthosis intervention

Collaborators and Investigators

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

Sponsor

The University of Texas Medical Branch, Galveston

Investigators

  • Principal Investigator: Barbara M. Doucet, PhD, Louisiana State University Health Sciences Center

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

May 1, 2011

Primary Completion (ACTUAL)

December 1, 2012

Study Completion (ACTUAL)

October 1, 2013

Study Registration Dates

First Submitted

August 16, 2016

First Submitted That Met QC Criteria

August 29, 2016

First Posted (ESTIMATE)

September 2, 2016

Study Record Updates

Last Update Posted (ACTUAL)

May 29, 2019

Last Update Submitted That Met QC Criteria

May 24, 2019

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual data are confidential.

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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