EMG-Controlled Game to Retrain Upper Extremity Muscle Act... | NCT05628324

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

NCT05628324

Sponsor

VA Office of Research and Development

Status

Recruiting

Last Update Posted

Aug 26, 2025Actual

Enrollment

62Estimated

Phase

Not Applicable

Conditions

Stroke

Interventions

practice muscle activation patterns
task practice

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
I01RX004523	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 31, 2024Actual

Primary Completion Date

Mar 31, 2027Estimated

Completion Date

Mar 31, 2027Estimated

First Submitted Date

Nov 16, 2022

First Submission Date that Met QC Criteria

Nov 16, 2022

First Posted Date

Nov 28, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 25, 2025

Last Update Posted Date

Aug 26, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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 training, and/or upper extremity functional assessments.

Detailed Description

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

62Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
EMG + task training	Experimental	Train with EMG-controlled games and functional task practice	Behavioral: practice muscle activation patterns Behavioral: task practice
task training	Active Comparator	Train with functional task practice	Behavioral: task practice

Interventions

Name	Type	Description	Arm Group Labels	Other Names
practice muscle activation patterns	Behavioral	practice upper limb muscle activation patterns using EMG-controlled games	EMG + task training

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Wolf Motor Function Test	Functional abilities scale for completing upper limb tasks	Within 1 week from intervention completion

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sarah A Jackson, BA MA	Contact	(843) 789-6700		sarah.jackson@va.gov

Overall Officials

Name	Affiliation	Role
Na Jin Seo, PhD MS BS	Ralph H. Johnson VA Medical Center, Charleston, SC	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ralph H. Johnson VA Medical Center, Charleston, SC	Recruiting	Charleston	South Carolina	29401-5703	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Only de-identified data will be shared in publications, in conference presentations, and upon data sharing request.

Types

Not provided

Time Frame

After the primary data are published for up to 5 years from the study completion.

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020521	Stroke

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided