StrokeGAMNCT05628324
EMG-Controlled Game to Retrain Upper Extremity Muscle Activation Patterns Following Stroke
A study testing practice muscle activation patterns and task practice in people with Stroke, run by VA Office of Research and Development at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- practice muscle activation patterns and task practice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2024to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Ralph H. Johnson VA Medical Center, Charleston, SC
Charleston, South Carolina, 29401-5703
Sarah A Jackson, BA MA, (843) 789-6700, sarah.jackson@va.gov
Na Jin Seo, PhD MS BS
About this study
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- practice muscle activation patterns, task practice
- Keywords
- upper limb, rehabilitation, EMG muscle activation pattern, serious game, virtual reality, biofeedback
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
practice muscle activation patternsBehavioural
practice upper limb muscle activation patterns using EMG-controlled games
task practiceBehavioural
practice functional upper limb tasks
| Study group | Role | What they receive |
|---|---|---|
| EMG + task training | Experimental | Train with EMG-controlled games and functional task practice Receives: Behavioral: practice muscle activation patterns; Behavioral: task practice |
| task training | Active comparator | Train with functional task practice Receives: Behavioral: task practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wolf Motor Function Test
Functional abilities scale for completing upper limb tasks
Measured: Within 1 week from intervention completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2022
- Study start31 Jul 2024
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2-arm randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Na Jin Seo, PhD MS BS, Principal investigator, Ralph H. Johnson VA Medical Center, Charleston, SC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05628324
- Sponsor's protocol ID
- A4523-R
- Other IDs
- I01RX004523
- Acronym
- GAM
- Status last verified
- Oct 2026
- First submitted
- 16 Nov 2022
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only de-identified data will be shared in publications, in conference presentations, and upon data sharing request.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EMG-Controlled Game to Retrain Upper Extremity Muscle Activation Patterns Following Stroke
- ClinicalTrials.gov ID
- NCT05628324
- Acronym / sponsor ID
- GAM / A4523-R
- Conditions
- Stroke
- Keywords
- upper limb, rehabilitation, EMG muscle activation pattern, serious game, virtual reality, biofeedback
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 31 Jul 2024 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 28 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 2-arm randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| EMG + task training | Experimental | Behavioral: practice muscle activation patterns, Behavioral: task practiceTrain with EMG-controlled games and functional task practice |
| task training | Active comparator | Behavioral: task practiceTrain with functional task practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| practice muscle activation patternspractice upper limb muscle activation patterns using EMG-controlled games | Behavioural | EMG + task training |
| task practicepractice functional upper limb tasks | Behavioural | EMG + task training, task training |
Primary outcome
Wolf Motor Function Test
Time frame: Within 1 week from intervention completion
Functional abilities scale for completing upper limb tasks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: Yes. Only de-identified data will be shared in publications, in conference presentations, and upon data sharing request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Na Jin Seo, PhD MS BS principal investigator
Ralph H. Johnson VA Medical Center, Charleston, SC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing practice muscle activation patterns and task practice in people with Stroke, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah A Jackson, BA MA ((843) 789-6700, sarah.jackson@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wolf Motor Function Test (time frame: Within 1 week from intervention completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.