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NCT Number: NCT03401762

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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke, Acute Vascular Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University

Chicago, Illinois, 60611, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

MCI

Behavioral

EMG-controlled game

Sham MCI

Behavioral

Sham control game

Primary outcomes

  1. Wolf Motor Function Test

    Time frame: baseline to 6 weeks

    Timed

Secondary outcomes

  1. Fugl-Meyer Assessment - Upper Extremity (UE)

    Time frame: baseline to 6 weeks

  2. Motor Activity Log

    Time frame: baseline to 6 weeks

  3. Modified Ashworth Scale

    Time frame: baseline to 6 weeks

    Total score

  4. Fugl-Meyer Assessment UE

    Time frame: baseline to 10 weeks

  5. Wolf Motor Function Test

    Time frame: baseline to 10 weeks

    Timed

Study contacts

Contact information is provided by the study sponsor or research team.

Cynthia Gorski

CONTACT

[email protected]

Marc W Slutzky, MD, PhD

CONTACT

[email protected]

3125034653

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • National Institutes of Health (NIH)
  • Shirley Ryan AbilityLab

Registry information

Important dates

Study start
2018
Primary completion
2027
Study completion
2027
First posted
Jan 17, 2018
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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