Back to resultsMyoelectric Computer Interface to Reduce Muscle Co-activation After Stroke
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
60-min isometric MyCI training
90-min isometric MyCI training
90-min movement MyCI training
Sponsored by
About this trial
This is an interventional treatment trial for Stroke
Eligibility Criteria
Inclusion Criteria:
- Stroke survivors at least 6 months after stroke onset
- Persistent moderate to severe arm impairment
- Increased arm tone
Exclusion Criteria:
- Substantial impairment of vision, memory, language or concentration
- Botulinum toxin use in the affected arm
- Concomitant participation in another research study on the arm
Sites / Locations
- Northwestern University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
60-minute Isometric
90-minute Isometric
90-minute Movement
Arm Description
60-min Isometric MyCI training: EMG-controlled game training for 60-minutes per session
90-min Isometric MyCI training: EMG-controlled game training for 90-minutes per session
90-min movement MyCI training: EMG-controlled game training for 90-minutes per session
Outcomes
Primary Outcome Measures
Fugl-Meyer Assessment - Upper Extremity
Scale 0-66, total score
Secondary Outcome Measures
Fugl-Meyer Assessment - Upper Extremity
Scale 0-66, total score
Wolf Motor Function Test
Timed test
Motor Activity Log
30-question test, total score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03579992
Brief Title
Myoelectric Computer Interface to Reduce Muscle Co-activation After Stroke
Official Title
Myoelectric Computer Interface to Reduce Muscle Co-activation After Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
July 2014 (Actual)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study examines whether in-lab training with a myoelectric-computer interface (MyCI) can reduce abnormal muscle co-activation after stroke.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Occupational Therapists were blinded to intervention group
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
60-minute Isometric
Arm Type
Experimental
Arm Description
60-min Isometric MyCI training: EMG-controlled game training for 60-minutes per session
Arm Title
90-minute Isometric
Arm Type
Experimental
Arm Description
90-min Isometric MyCI training: EMG-controlled game training for 90-minutes per session
Arm Title
90-minute Movement
Arm Type
Experimental
Arm Description
90-min movement MyCI training: EMG-controlled game training for 90-minutes per session
Intervention Type
Behavioral
Intervention Name(s)
60-min isometric MyCI training
Intervention Description
EMG-controlled in-lab training with arm restrained for 60 minutes per session
Intervention Type
Behavioral
Intervention Name(s)
90-min isometric MyCI training
Intervention Description
EMG-controlled in-lab training with arm restrained for 90 minutes per session
Intervention Type
Behavioral
Intervention Name(s)
90-min movement MyCI training
Intervention Description
EMG-controlled in-lab training without restraint for 90 minutes per session
Primary Outcome Measure Information:
Title
Fugl-Meyer Assessment - Upper Extremity
Description
Scale 0-66, total score
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Fugl-Meyer Assessment - Upper Extremity
Description
Scale 0-66, total score
Time Frame
10 weeks
Title
Wolf Motor Function Test
Description
Timed test
Time Frame
6 and 10 weeks
Title
Motor Activity Log
Description
30-question test, total score
Time Frame
6 and 10 weeks
Other Pre-specified Outcome Measures:
Title
Modified Ashworth Scale
Time Frame
6 and 10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Stroke survivors at least 6 months after stroke onset
Persistent moderate to severe arm impairment
Increased arm tone
Exclusion Criteria:
Substantial impairment of vision, memory, language or concentration
Botulinum toxin use in the affected arm
Concomitant participation in another research study on the arm
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Slutzky, MD, PhD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
30888251
Citation
Mugler EM, Tomic G, Singh A, Hameed S, Lindberg EW, Gaide J, Alqadi M, Robinson E, Dalzotto K, Limoli C, Jacobson T, Lee J, Slutzky MW. Myoelectric Computer Interface Training for Reducing Co-Activation and Enhancing Arm Movement in Chronic Stroke Survivors: A Randomized Trial. Neurorehabil Neural Repair. 2019 Apr;33(4):284-295. doi: 10.1177/1545968319834903. Epub 2019 Mar 19.
Results Reference
result
PubMed Identifier
35778757
Citation
Seo G, Kishta A, Mugler E, Slutzky MW, Roh J. Myoelectric interface training enables targeted reduction in abnormal muscle co-activation. J Neuroeng Rehabil. 2022 Jul 1;19(1):67. doi: 10.1186/s12984-022-01045-z.
Results Reference
derived
Learn more about this trial
Myoelectric Computer Interface to Reduce Muscle Co-activation After Stroke
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