- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05628324
EMG-Controlled Game to Retrain Upper Extremity Muscle Activation Patterns Following Stroke (GAM)
August 25, 2025 updated by: VA Office of Research and Development
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Estimated)
62
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 Contact
- Name: Sarah A Jackson, BA MA
- Phone Number: (843) 789-6700
- Email: sarah.jackson@va.gov
Study Locations
-
-
South Carolina
-
Charleston, South Carolina, United States, 29401-5703
- Recruiting
- Ralph H. Johnson VA Medical Center, Charleston, SC
-
Contact:
- Sarah A Jackson, BA MA
- Phone Number: 843-789-6700
- Email: sarah.jackson@va.gov
-
Principal Investigator:
- Na Jin Seo, PhD MS BS
-
-
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
Yes
Description
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
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 Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: EMG + task training
Train with EMG-controlled games and functional task practice
|
practice upper limb muscle activation patterns using EMG-controlled games
practice functional upper limb tasks
|
|
Active Comparator: task training
Train with functional task practice
|
practice functional upper limb tasks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Wolf Motor Function Test
Time Frame: Within 1 week from intervention completion
|
Functional abilities scale for completing upper limb tasks
|
Within 1 week from intervention completion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Na Jin Seo, PhD MS BS, Ralph H. Johnson VA Medical Center, Charleston, SC
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 (Actual)
July 31, 2024
Primary Completion (Estimated)
March 31, 2027
Study Completion (Estimated)
March 31, 2027
Study Registration Dates
First Submitted
November 16, 2022
First Submitted That Met QC Criteria
November 16, 2022
First Posted (Actual)
November 28, 2022
Study Record Updates
Last Update Posted (Estimated)
August 26, 2025
Last Update Submitted That Met QC Criteria
August 25, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- A4523-R
- I01RX004523 (U.S. NIH Grant/Contract: VA)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Only de-identified data will be shared in publications, in conference presentations, and upon data sharing request.
IPD Sharing Time Frame
After the primary data are published for up to 5 years from the study completion.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.