Status:
RECRUITING
Wearable MCI to Reduce Muscle Co-activation in Acute and Chronic Stroke
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
Shirley Ryan AbilityLab
National Institutes of Health (NIH)
Conditions:
Stroke
Stroke, Acute
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
The purpose of the study is to explore the feasibility of using a wearable device, called a myoelectric-computer interface (MCI), to improve arm movement in people who have had a stroke. Impaired arm...
Eligibility Criteria
Inclusion
- Chronic stroke participants
- Hemiparesis from first ever stroke at least 6 months prior to screening
- Severe motor impairment (FMA of 7-30)
- At least some voluntary shoulder and elbow muscle activation.
- Acute stroke participants
- Hemiparesis from first ever stroke within the past 21 days
- Severe motor impairment (FMA of 3-20), or total Manual Motor Score of 1-8 combined in Shoulder Abduction and Finger Extensors
Exclusion
- Cognitive impairment with at least moderately impaired attention, or unable to follow instructions of the MCI task
- Visual impairment (such as hemianopia) preventing full view of the screen
- Anesthesia or neglect in the affected arm, or visual hemineglect (score of 2 on the NIH Stroke Scale Extinction and Inattention subtest).
- Participation in another study on the affected arm within 6 weeks of enrollment or any pharmacological study
- Inability to understand or follow commands in English due to aphasia or other reason
- Diffuse or multifocal infarcts
- Substantial arm pain preventing participation for 90 minutes a day
- New spasticity treatment (pharmacological or Botox)
Key Trial Info
Start Date :
January 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT03401762
Start Date
January 15 2018
End Date
December 1 2025
Last Update
November 25 2024
Active Locations (1)
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1
Northwestern University
Chicago, Illinois, United States, 60611