NCT05628324

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
10mo left

Started Jul 2024

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress68%
Jul 2024Mar 2027

First Submitted

Initial submission to the registry

November 16, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 28, 2022

Completed
1.7 years until next milestone

Study Start

First participant enrolled

July 31, 2024

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

August 26, 2025

Status Verified

August 1, 2025

Enrollment Period

2.7 years

First QC Date

November 16, 2022

Last Update Submit

August 25, 2025

Conditions

Stroke

Keywords

upper limbrehabilitationEMG muscle activation patternserious gamevirtual realitybiofeedback

Outcome Measures

Primary Outcomes (1)

  • Wolf Motor Function Test

    Functional abilities scale for completing upper limb tasks

    Within 1 week from intervention completion

Study Arms (2)

EMG + task training

EXPERIMENTAL

Train with EMG-controlled games and functional task practice

Behavioral: practice muscle activation patternsBehavioral: task practice

task training

ACTIVE COMPARATOR

Train with functional task practice

Behavioral: task practice

Interventions

practice muscle activation patternsBEHAVIORAL

practice upper limb muscle activation patterns using EMG-controlled games

EMG + task training
task practiceBEHAVIORAL

practice functional upper limb tasks

EMG + task trainingtask training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • + 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, 29401-5703, United States

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Na Jin Seo, PhD MS BS

    Ralph H. Johnson VA Medical Center, Charleston, SC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah A Jackson, BA MA

CONTACT

(843) 789-6700sarah.jackson@va.gov

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 2-arm randomized controlled trial
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2022

First Posted

November 28, 2022

Study Start

July 31, 2024

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Last Updated

August 26, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

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

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

Locations

US(1)