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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05628324
Other study ID # A4523-R
Secondary ID I01RX004523
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 1, 2024
Est. completion date March 31, 2027

Study information

Verified date June 2024
Source VA Office of Research and Development
Contact Sarah A Jackson, BA MA
Phone (843) 789-6700
Email sarah.jackson@va.gov
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 3 times a week for 6 weeks to receive upper limb task practice and/or muscle activity training. Participants will also come to the laboratory for additional 3 visits for assessments of upper extremity function. The total duration of the study will be 2.5 months.


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 3 times a week for 6 weeks to receive upper limb task practice and/or muscle activity training. Participants will also come to the laboratory for additional 3 visits for assessments of upper extremity function. The total duration of the study will be 2.5 months.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 62
Est. completion date March 31, 2027
Est. primary completion date March 31, 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 18+ years old Stroke more than 6 months ago Moderate 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
practice muscle activation patterns
practice upper limb muscle activation patterns using EMG-controlled games
task practice
practice functional upper limb tasks

Locations

Country Name City State
United States Ralph H. Johnson VA Medical Center, Charleston, SC Charleston South Carolina

Sponsors (1)

Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Wolf Motor Function Test Functional abilities scale for completing upper limb tasks within 1 week from intervention completion
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