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Wearable MCI to Reduce Muscle Co-activation in Acute and Chronic Stroke

Wearable MCI to Reduce Muscle Co-activation in Acute and Chronic Stroke

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03401762
Enrollment
96
Registered
2018-01-17
Start date
2018-01-15
Completion date
2027-04-01
Last updated
2026-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke, Stroke, Acute

Keywords

rehabilitation

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 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.

Interventions

BEHAVIORALMCI

EMG-controlled game

BEHAVIORALSham MCI

Sham control game

Sponsors

Northwestern University
Lead SponsorOTHER
Shirley Ryan AbilityLab
CollaboratorOTHER
National Institutes of Health (NIH)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Participants will be blinded as to sham vs. intervention, but not as to which interventional arm.

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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 criteria

* 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)

Design outcomes

Primary

MeasureTime frameDescription
Wolf Motor Function Testbaseline to 6 weeksTimed

Secondary

MeasureTime frameDescription
Fugl-Meyer Assessment - Upper Extremity (UE)baseline to 6 weeks
Motor Activity Logbaseline to 6 weeks
Modified Ashworth Scalebaseline to 6 weeksTotal score
Fugl-Meyer Assessment UEbaseline to 10 weeks
Wolf Motor Function Testbaseline to 10 weeksTimed

Countries

United States

Contacts

CONTACTMarc W Slutzky, MD, PhD
mslutzky@northwestern.edu3125034653
CONTACTCynthia Gorski
cynthia.gorski@northwestern.edu

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 10, 2026