Recruiting

MCI

Sponsor:

Northwestern University

Code:

NCT03401762

Conditions

Stroke

Stroke, Acute

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

MCI

Sham MCI

Study Details

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.

Conditions

Stroke

Stroke, Acute

Study ID

NCT03401762

Start date

Jan 15, 2018

Status verified date

Apr, 2026

Completion date

Apr, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

96 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Chronic stroke MCI Electromyogram (EMG) pairs

Decoupling 2 muscles at a time with MCI

experimental: Chronic stroke MCI EMG triplets

Decoupling 3 muscles at a time with MCI

experimental: Chronic stroke MCI while reaching

Decoupling muscles with MCI while reaching to targets

sham comparator: Chronic stroke Sham MCI

Sham control group

experimental: Acute stroke MCI

Decoupling muscles with MCI in acute stroke subjects

sham comparator: Acute stroke Sham MCI

Acute stroke subjects sham comparator

Interventions

MCI

EMG-controlled game

Sham MCI

Sham control game

Primary outcome measure

  • Wolf Motor Function Test [ Time Frame: baseline to 6 weeks ]

Central Contacts and Locations

Central contacts

Marc W Slutzky, MD, PhD

3125034653mslutzky@northwestern.edu

Cynthia Gorski

cynthia.gorski@northwestern.edu

Locations

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

More Information

Sponsor

Northwestern University

Last update posted

Apr 8, 2026

Last verified

Apr, 2026

Keywords

  • rehabilitation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Northwestern University on 2026-04-08.