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Behavioral Intervention
Wearable MCI for Stroke
N/A
Recruiting
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Chronic stroke participants with hemiparesis from first ever stroke at least 6 months prior to screening, severe motor impairment (FMA of 7-30), and at least some voluntary shoulder and elbow muscle activation.
Be older than 18 years old
Must not have
Substantial arm pain preventing participation for 90 minutes a day
Visual impairment (such as hemianopia) preventing full view of the screen
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 10 weeks
Summary
This trial will test whether a wearable device that provides feedback about muscle activation can improve arm movement in people who have had a stroke.
Who is the study for?
This trial is for individuals who have had a stroke, either recently (within the past 21 days) or chronically (at least 6 months ago). Participants must have severe motor impairment but some ability to move their shoulder and elbow. They cannot be part of another study, have significant cognitive or visual impairments, new spasticity treatments, anesthesia in the arm, or substantial pain that would prevent daily participation.
What is being tested?
The study is testing a wearable device called an MCI designed to improve arm movement by reducing muscle co-activation issues caused by strokes. It's a randomized controlled trial where participants will use the MCI at home and their progress with arm movements will be monitored.
What are the potential side effects?
Since this intervention involves using a non-invasive wearable device providing feedback on muscle activation without drugs or surgery, side effects are minimal but may include discomfort from wearing the device.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I had a stroke over 6 months ago, have severe arm weakness but can still move my shoulder and elbow a bit.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have severe arm pain that stops me from participating in activities for 90 minutes a day.
Select...
I have a visual impairment that prevents me from seeing the whole screen.
Select...
I am starting a new treatment for muscle stiffness.
Select...
I have trouble paying attention or following instructions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 10 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 10 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Modified Ashworth Scale
Wolf Motor Function Test
Trial Design
6Treatment groups
Experimental Treatment
Placebo Group
Group I: Chronic stroke MCI while reachingExperimental Treatment1 Intervention
Decoupling muscles with MCI while reaching to targets
Group II: Chronic stroke MCI Electromyogram (EMG) pairsExperimental Treatment1 Intervention
Decoupling 2 muscles at a time with MCI
Group III: Chronic stroke MCI EMG tripletsExperimental Treatment1 Intervention
Decoupling 3 muscles at a time with MCI
Group IV: Acute stroke MCIExperimental Treatment1 Intervention
Decoupling muscles with MCI in acute stroke subjects
Group V: Chronic stroke Sham MCIPlacebo Group1 Intervention
Sham control group
Group VI: Acute stroke Sham MCIPlacebo Group1 Intervention
Acute stroke subjects sham comparator
Find a Location
Who is running the clinical trial?
Northwestern UniversityLead Sponsor
1,652 Previous Clinical Trials
961,419 Total Patients Enrolled
34 Trials studying Stroke
25,335 Patients Enrolled for Stroke
Shirley Ryan AbilityLabOTHER
208 Previous Clinical Trials
17,829 Total Patients Enrolled
74 Trials studying Stroke
8,671 Patients Enrolled for Stroke
National Institutes of Health (NIH)NIH
2,840 Previous Clinical Trials
8,172,022 Total Patients Enrolled
44 Trials studying Stroke
8,415 Patients Enrolled for Stroke