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Completed

NCT Number: NCT02887872

Electrical Stimulation and a Dynamic Orthosis for Stroke Recovery

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.

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Key information

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas Medical Branch

Galveston, Texas, 77555, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • have a diagnosis of ischemic or hemorrhagic stroke that occurred at least six months prior to date of participation;
  • be between 20 and 85 years of age;
  • exhibit a minimal amount of upper extremity movement (approximately 10° active wrist or digit movement);
  • be able to communicate orally and provide informed consent; and
  • 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.)

Treatment and study plan

Electrical stimulation-dynamic hand orthosis

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

The University of Texas Medical Branch, Galveston

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Sep 2, 2016
Registry last updated
May 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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