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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.
Acute stroke participants with 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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 10 weeks
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 below
Select...
I had a stroke over 6 months ago, have severe arm weakness but can still move my shoulder and elbow a bit.
Select...
I had my first stroke within the last 21 days and have severe arm weakness.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 10 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 10 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Fugl-Meyer Assessment - Upper Extremity (UE)
Fugl-Meyer Assessment UE
Modified Ashworth Scale
+2 more

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
1,579 Previous Clinical Trials
916,689 Total Patients Enrolled
30 Trials studying Stroke
25,109 Patients Enrolled for Stroke
Shirley Ryan AbilityLabOTHER
192 Previous Clinical Trials
14,789 Total Patients Enrolled
69 Trials studying Stroke
6,249 Patients Enrolled for Stroke
National Institutes of Health (NIH)NIH
2,682 Previous Clinical Trials
6,930,702 Total Patients Enrolled
38 Trials studying Stroke
7,704 Patients Enrolled for Stroke

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there current availability for individuals to join this medical experiment?

"Affirmative. The clinicaltrials.gov website demonstrates that this trial, initially posted on January 15th 2018 and amended last on December 9th 2021, is actively looking for 96 participants from a single site."

Answered by AI

How many participants are engaging in this clinical investigation?

"Correct. The clinicaltrials.gov portal confirms that this study, initially posted on January 15th 2018, is currently seeking candidates to participate. 96 individuals are required from a single site."

Answered by AI
~5 spots leftby Aug 2024