Back to resultsEMG-Controlled Game to Retrain Upper Extremity Muscle Activation Patterns Following Stroke (GAM)
Primary Purpose
Stroke
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
practice muscle activation patterns
task practice
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring upper limb, rehabilitation, EMG muscle activation pattern, serious game, virtual reality, biofeedback
Eligibility Criteria
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 Severe spasticity prohibiting voluntary muscle contraction to participate 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
Sites / Locations
- Ralph H. Johnson VA Medical Center, Charleston, SC
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
EMG + task training
task training
Arm Description
Train with EMG-controlled games and functional task practice
Train with functional task practice for a total of 18 sessions
Outcomes
Primary Outcome Measures
Wolf Motor Function Test
Functional abilities scale for completing upper limb tasks
Secondary Outcome Measures
Full Information
NCT ID
NCT05628324
First Posted
November 16, 2022
Last Updated
August 18, 2023
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT05628324
Brief Title
EMG-Controlled Game to Retrain Upper Extremity Muscle Activation Patterns Following Stroke
Acronym
GAM
Official Title
EMG-Controlled Game to Retrain Upper Extremity Muscle Activation Patterns Following Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
March 31, 2027 (Anticipated)
Study Completion Date
March 31, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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 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.
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
upper limb, rehabilitation, EMG muscle activation pattern, serious game, virtual reality, biofeedback
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2-arm randomized controlled trial
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
62 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EMG + task training
Arm Type
Experimental
Arm Description
Train with EMG-controlled games and functional task practice
Arm Title
task training
Arm Type
Active Comparator
Arm Description
Train with functional task practice for a total of 18 sessions
Intervention Type
Behavioral
Intervention Name(s)
practice muscle activation patterns
Intervention Description
practice upper limb muscle activation patterns using EMG-controlled games
Intervention Type
Behavioral
Intervention Name(s)
task practice
Intervention Description
practice functional upper limb tasks
Primary Outcome Measure Information:
Title
Wolf Motor Function Test
Description
Functional abilities scale for completing upper limb tasks
Time Frame
within 1 week from intervention completion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 Severe spasticity prohibiting voluntary muscle contraction to participate 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah A Jackson, BA MA
Phone
(843) 789-6700
Email
sarah.jackson@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Na Jin Seo, PhD MS BS
Organizational Affiliation
Ralph H. Johnson VA Medical Center, Charleston, SC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ralph H. Johnson VA Medical Center, Charleston, SC
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401-5703
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah A Jackson, BA MA
Phone
843-789-6700
Email
sarah.jackson@va.gov
First Name & Middle Initial & Last Name & Degree
Na Jin Seo, PhD MS BS
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
EMG-Controlled Game to Retrain Upper Extremity Muscle Activation Patterns Following Stroke
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