Myoelectric Computer Interface to Reduce Muscle Co-activation After Stroke
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Northwestern University
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: 60-minute Isometric
60-min Isometric MyCI training: EMG-controlled game training for 60-minutes per session
|
EMG-controlled in-lab training with arm restrained for 60 minutes per session
|
|
Experimental: 90-minute Isometric
90-min Isometric MyCI training: EMG-controlled game training for 90-minutes per session
|
EMG-controlled in-lab training with arm restrained for 90 minutes per session
|
|
Experimental: 90-minute Movement
90-min movement MyCI training: EMG-controlled game training for 90-minutes per session
|
EMG-controlled in-lab training without restraint for 90 minutes per session
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fugl-Meyer Assessment - Upper Extremity
Time Frame: 6 weeks
|
Scale 0-66, total score
|
6 weeks
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fugl-Meyer Assessment - Upper Extremity
Time Frame: 10 weeks
|
Scale 0-66, total score
|
10 weeks
|
|
Wolf Motor Function Test
Time Frame: 6 and 10 weeks
|
Timed test
|
6 and 10 weeks
|
|
Motor Activity Log
Time Frame: 6 and 10 weeks
|
30-question test, total score
|
6 and 10 weeks
|
Other Outcome Measures
Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Modified Ashworth Scale
Time Frame: 6 and 10 weeks
|
6 and 10 weeks
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Marc Slutzky, MD, PhD, Northwestern University
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- STU00042554
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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