EMG-Controlled Game to Retrain Upper Extremity Muscle Activation Patterns Following Stroke

NCT ID: NCT05628324

Last Updated: 2025-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-31

Study Completion Date

2027-03-31

Brief Summary

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The purpose of this study is to develop and test if upper limb task practice and muscle activity training improve upper limb function in stroke survivors. Participants will be asked to come to the laboratory 23 times (approximately 3 times a week) over 2.5 months to receive upper limb task practice, muscle activity training, and/or upper extremity functional assessments.

Detailed Description

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The purpose of this study is to develop and test if upper limb task practice and muscle activity training improve upper limb function in stroke survivors. Participants will be asked to come to the laboratory 23 times (approximately 3 times a week) over 2.5 months to receive upper limb task practice, muscle activity training, and/or upper extremity functional assessments.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

2-arm randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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EMG + task training

Train with EMG-controlled games and functional task practice

Group Type EXPERIMENTAL

practice muscle activation patterns

Intervention Type BEHAVIORAL

practice upper limb muscle activation patterns using EMG-controlled games

task practice

Intervention Type BEHAVIORAL

practice functional upper limb tasks

task training

Train with functional task practice

Group Type ACTIVE_COMPARATOR

task practice

Intervention Type BEHAVIORAL

practice functional upper limb tasks

Interventions

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practice muscle activation patterns

practice upper limb muscle activation patterns using EMG-controlled games

Intervention Type BEHAVIORAL

task practice

practice functional upper limb tasks

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 18+ years old
* Stroke more than 6 months ago
* Moderate unilateral upper limb impairment
* Cognitive ability to participate in the study procedure
* Ability to see the full computer screen

Exclusion Criteria

* Concurrent upper limb rehabilitation
* Inability to voluntarily contract muscles of at least 2 upper limb muscle groups, prohibiting participation in training
* Change in spasticity medication or botulinum toxin injection in the upper limb within 3 months prior to or during enrollment
* Total sensory loss
* Comorbidity (e.g., orthopaedic or premorbid neurologic condition) that limit upper limb movement and/or participation in the intervention
* Language barrier or cognitive impairment that precludes providing consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Na Jin Seo, PhD MS BS

Role: PRINCIPAL_INVESTIGATOR

Ralph H. Johnson VA Medical Center, Charleston, SC

Locations

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Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Sarah A Jackson, BA MA

Role: CONTACT

(843) 789-6700

Facility Contacts

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Sarah A Jackson, BA MA

Role: primary

843-789-6700

Other Identifiers

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I01RX004523

Identifier Type: NIH

Identifier Source: secondary_id

View Link

A4523-R

Identifier Type: -

Identifier Source: org_study_id

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