Wearable MCI to Reduce Muscle Co-activation in Acute and Chronic Stroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorNorthwestern University
About this trial
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 movement after stroke is caused not just by weakness, but also by impaired coordination between joints due to abnormal co-activation of muscles. These abnormal co-activation patterns are thought to be due to abnormal movement planning.The MCI aims to reduce abnormal co-activation by providing feedback about individual muscle activations.
This randomized, controlled, blinded study will test the home use of an MCI in chronic and acute stroke survivors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Hemiparesis from first ever stroke within the past 21 days
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
MCI
BehavioralEMG-controlled game
Sham MCI
BehavioralSham control game
Treatment groups
96 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Chronic stroke MCI Electromyogram (EMG) pairsExperimental treatment 1 intervention
Group B: Chronic stroke MCI EMG tripletsExperimental treatment 1 intervention
Group C: Chronic stroke MCI while reachingExperimental treatment 1 intervention
Group D: Chronic stroke Sham MCISham comparator 1 intervention
Group E: Acute stroke MCIExperimental treatment 1 intervention
Group F: Acute stroke Sham MCISham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Wolf Motor Function Test
Timed
Time frame
baseline to 6 weeksSecondary outcomes
1
Fugl-Meyer Assessment - Upper Extremity (UE)
Time frame
baseline to 6 weeks2
Motor Activity Log
Time frame
baseline to 6 weeks3
Modified Ashworth Scale
Total score
Time frame
baseline to 6 weeks4
Fugl-Meyer Assessment UE
Time frame
baseline to 10 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Northwestern University
Lead sponsor
Shirley Ryan AbilityLab
Collaborator
National Institutes of Health (NIH)
Collaborator
Source ClinicalTrials.gov