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Recruiting NCT03401762

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

No phase Interventional Stroke Stroke, Acute

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MCI, Sham MCI.
Who it may be relevant to
Registry conditions: Stroke, Stroke, Acute. Basic parameters: from 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • Behavioral MCI
    EMG-controlled game
  • Behavioral Sham MCI
    Sham control game

Primary outcome measures

  • Wolf Motor Function Test [Time frame: baseline to 6 weeks]
Secondary outcome measures (5)
  • Fugl-Meyer Assessment - Upper Extremity (UE) [Time frame: baseline to 6 weeks]
  • Motor Activity Log [Time frame: baseline to 6 weeks]
  • Modified Ashworth Scale [Time frame: baseline to 6 weeks]
  • Fugl-Meyer Assessment UE [Time frame: baseline to 10 weeks]
  • Wolf Motor Function Test [Time frame: baseline to 10 weeks]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Northwestern University — Chicago

Publications

  • Khorasani A, Gorski CM, Hung NT, Hulsizer J, Paul V, Tomic G, Prakash PR, Park S, Seo G, Houskamp EJ, Lanis J, Hunzeker M, King E, Chappel A, Jampol A, Patel P, Gallagher C, Galant R, Rucker G, Lee J, Harvey RL, Roh J, Slutzky MW. Wearable Myoelectric Interface for Neurorehabilitation (MINT) to Recover Arm Activity After Stroke: A Randomized Controlled Trial. Neurorehabil Neural Repair. 2026 Jun 8 PMID 42261097
  • Khorasani A, Gorski CM, Hung NT, Hulsizer J, Paul V, Tomic G, Prakash PR, Park S, Seo G, Houskamp EJ, Lanis J, Hunzeker M, King E, Chappel A, Jampol A, Patel P, Gallagher C, Galant R, Rucker G, Lee J, Harvey R, Roh J, Slutzky MW. Wearable Myoelectric Interface for Neurorehabilitation (MINT) to Recover Arm Function: a Randomized Controlled Trial. medRxiv [Preprint]. 2025 Jun 25:2025.06.24.25330240. PMID 40666333
  • Khorasani A, Hulsizer J, Paul V, Gorski C, Dhaher YY, Slutzky MW. Myoelectric interface for neurorehabilitation conditioning to reduce abnormal leg co-activation after stroke: a pilot study. J Neuroeng Rehabil. 2024 Jan 20;21(1):11. doi: 10.1186/s12984-024-01305-0. PMID 38245730
  • Khorasani A, Hulsizer J, Paul V, Gorski C, Dhaher YY, Slutzky MW. Myoelectric interface for neurorehabilitation conditioning to reduce abnormal leg co-activation after stroke: a pilot study. Res Sq [Preprint]. 2023 Oct 9:rs.3.rs-3398815. doi: 10.21203/rs.3.rs-3398815/v1. PMID 37886579
  • Hung NT, Paul V, Prakash P, Kovach T, Tacy G, Tomic G, Park S, Jacobson T, Jampol A, Patel P, Chappel A, King E, Slutzky MW. Wearable myoelectric interface enables high-dose, home-based training in severely impaired chronic stroke survivors. Ann Clin Transl Neurol. 2021 Sep;8(9):1895-1905. doi: 10.1002/acn3.51442. Epub 2021 Aug 20. PMID 34415114

Identifiers

NCT: NCT03401762 · STU00203644

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗