Back to resultsEMG Training for Altering Activation Patterns After Stroke
Primary Purpose
Stroke, Weakness, Muscle, Coordination Lack
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bilateral
Unilateral
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring hand, stroke, therapy, rehabilitation
Eligibility Criteria
Inclusion Criteria:
- Single, unilateral stroke at least 6 months prior to enrollment
- Moderate hand impairment defined by Stage 4 or Stage 5 on the Chedoke McMaster Stroke Assessment Scale
Exclusion Criteria:
- Visual neglect or deficits (with inability to compensate)
- Upper extremity orthopedic conditions that interfere with movement
- Cerebellar stroke
Children, prisoners, or adult unable to provide consent will not be recruited. As the procedures pose no increased risk for pregnant women, we will not specifically exclude them.
Sites / Locations
- Shirley Ryan AbilityLab
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Bilateral
Unilateral
Arm Description
Participants will control game using EMG from both upper limbs.
Participants will control game using the more impaired upper limb.
Outcomes
Primary Outcome Measures
Change in mean completion time for timed test
Time to complete movement to 16 randomized targets
Secondary Outcome Measures
Full Information
NCT ID
NCT03619772
First Posted
August 3, 2018
Last Updated
May 2, 2022
Sponsor
Shirley Ryan AbilityLab
Collaborators
North Carolina State University, Marquette University, Medical University of South Carolina
1. Study Identification
Unique Protocol Identification Number
NCT03619772
Brief Title
EMG Training for Altering Activation Patterns After Stroke
Official Title
Altering Activation Patterns With EMG Training in the Distal Upper Extremity After Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 28, 2018 (Actual)
Primary Completion Date
October 31, 2020 (Actual)
Study Completion Date
October 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shirley Ryan AbilityLab
Collaborators
North Carolina State University, Marquette University, Medical University of South Carolina
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Evaluation of a new EMG controlled game to improve hand function in chronic stroke survivors.
Detailed Description
Increased impairment of the hand is commonly reported as an outcome occurring after a stroke. This impairment is due mainly to the decreased ability to modulate appropriate muscle activation patterns. Issues with appropriately modifying activation patterns can profoundly affect tasks of daily living. This study is evaluating a novel software focusing on retraining hand muscle activation patterns through an Electromyographic (EMG) controlled game. Stroke survivors with chronic, severe hemiparesis of the hand will participate in a longitudinal study consisting of 3 weeks of training. We hypothesize that stroke survivors will experience a decrease in time to complete a test of EMG control, as well as improvement in hand motor control.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Weakness, Muscle, Coordination Lack
Keywords
hand, stroke, therapy, rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bilateral
Arm Type
Experimental
Arm Description
Participants will control game using EMG from both upper limbs.
Arm Title
Unilateral
Arm Type
Active Comparator
Arm Description
Participants will control game using the more impaired upper limb.
Intervention Type
Other
Intervention Name(s)
Bilateral
Intervention Description
Participants will control game using EMG from both upper limbs.
Intervention Type
Other
Intervention Name(s)
Unilateral
Intervention Description
Participants will control game using EMG from the more impaired upper limb.
Primary Outcome Measure Information:
Title
Change in mean completion time for timed test
Description
Time to complete movement to 16 randomized targets
Time Frame
Baseline and 3 weeks (immediately post intervention)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Single, unilateral stroke at least 6 months prior to enrollment
Moderate hand impairment defined by Stage 4 or Stage 5 on the Chedoke McMaster Stroke Assessment Scale
Exclusion Criteria:
Visual neglect or deficits (with inability to compensate)
Upper extremity orthopedic conditions that interfere with movement
Cerebellar stroke
Children, prisoners, or adult unable to provide consent will not be recruited. As the procedures pose no increased risk for pregnant women, we will not specifically exclude them.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elliot Roth, MD
Organizational Affiliation
Shirley Ryan AbilityLab
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shirley Ryan AbilityLab
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35320135
Citation
Seo NJ, Barry A, Ghassemi M, Triandafilou KM, Stoykov ME, Vidakovic L, Roth E, Kamper DG. Use of an EMG-Controlled Game as a Therapeutic Tool to Retrain Hand Muscle Activation Patterns Following Stroke: A Pilot Study. J Neurol Phys Ther. 2022 Jul 1;46(3):198-205. doi: 10.1097/NPT.0000000000000398. Epub 2022 Mar 22.
Results Reference
derived
Learn more about this trial
EMG Training for Altering Activation Patterns After Stroke
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