NCT03401762

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P75+ for not_applicable stroke

Timeline
10mo left

Started Jan 2018

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Jan 2018Apr 2027

First Submitted

Initial submission to the registry

January 9, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

January 15, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 17, 2018

Completed
9.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

9.2 years

First QC Date

January 9, 2018

Last Update Submit

April 7, 2026

Conditions

Stroke, AcuteStroke

Keywords

rehabilitation

Outcome Measures

Primary Outcomes (1)

  • Wolf Motor Function Test

    Timed

    baseline to 6 weeks

Secondary Outcomes (5)

  • Fugl-Meyer Assessment - Upper Extremity (UE)

    baseline to 6 weeks

  • Motor Activity Log

    baseline to 6 weeks

  • Modified Ashworth Scale

    baseline to 6 weeks

  • Fugl-Meyer Assessment UE

    baseline to 10 weeks

  • Wolf Motor Function Test

    baseline to 10 weeks

Study Arms (6)

Chronic stroke MCI Electromyogram (EMG) pairs

EXPERIMENTAL

Decoupling 2 muscles at a time with MCI

Behavioral: MCI

Chronic stroke MCI EMG triplets

EXPERIMENTAL

Decoupling 3 muscles at a time with MCI

Behavioral: MCI

Chronic stroke MCI while reaching

EXPERIMENTAL

Decoupling muscles with MCI while reaching to targets

Behavioral: MCI

Chronic stroke Sham MCI

SHAM COMPARATOR

Sham control group

Behavioral: Sham MCI

Acute stroke MCI

EXPERIMENTAL

Decoupling muscles with MCI in acute stroke subjects

Behavioral: MCI

Acute stroke Sham MCI

SHAM COMPARATOR

Acute stroke subjects sham comparator

Behavioral: Sham MCI

Interventions

MCIBEHAVIORAL

EMG-controlled game

Acute stroke MCIChronic stroke MCI EMG tripletsChronic stroke MCI Electromyogram (EMG) pairsChronic stroke MCI while reaching
Sham MCIBEHAVIORAL

Sham control game

Acute stroke Sham MCIChronic stroke Sham MCI

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

Related Publications (4)

  • 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. doi: 10.1101/2025.06.24.25330240.

    PMID: 40666333DERIVED

  • 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: 38245730DERIVED

  • 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: 37886579DERIVED

  • 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: 34415114DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Marc W Slutzky, MD, PhD

CONTACT

3125034653mslutzky@northwestern.edu

Cynthia Gorski

CONTACT

cynthia.gorski@northwestern.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants will be blinded as to sham vs. intervention, but not as to which interventional arm.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 9, 2018

First Posted

January 17, 2018

Study Start

January 15, 2018

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

April 8, 2026

Record last verified: 2026-04

Locations

US(1)