NCT03579992

Brief Summary

This study examines whether in-lab training with a myoelectric-computer interface (MyCI) can reduce abnormal muscle co-activation after stroke.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Jul 2014

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

July 1, 2014

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 9, 2018

Completed
Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

3.3 years

First QC Date

June 28, 2018

Last Update Submit

April 7, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Fugl-Meyer Assessment - Upper Extremity

    Scale 0-66, total score

    6 weeks

Secondary Outcomes (3)

  • Fugl-Meyer Assessment - Upper Extremity

    10 weeks

  • Wolf Motor Function Test

    6 and 10 weeks

  • Motor Activity Log

    6 and 10 weeks

Other Outcomes (1)

  • Modified Ashworth Scale

    6 and 10 weeks

Study Arms (3)

60-minute Isometric

EXPERIMENTAL

60-min Isometric MyCI training: EMG-controlled game training for 60-minutes per session

Behavioral: 60-min isometric MyCI training

90-minute Isometric

EXPERIMENTAL

90-min Isometric MyCI training: EMG-controlled game training for 90-minutes per session

Behavioral: 90-min isometric MyCI training

90-minute Movement

EXPERIMENTAL

90-min movement MyCI training: EMG-controlled game training for 90-minutes per session

Behavioral: 90-min movement MyCI training

Interventions

EMG-controlled in-lab training with arm restrained for 60 minutes per session

60-minute Isometric

EMG-controlled in-lab training with arm restrained for 90 minutes per session

90-minute Isometric

EMG-controlled in-lab training without restraint for 90 minutes per session

90-minute Movement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stroke survivors at least 6 months after stroke onset
  • Persistent moderate to severe arm impairment
  • Increased arm tone

You may not qualify if:

  • Substantial impairment of vision, memory, language or concentration
  • Botulinum toxin use in the affected arm
  • Concomitant participation in another research study on the arm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (2)

  • Mugler EM, Tomic G, Singh A, Hameed S, Lindberg EW, Gaide J, Alqadi M, Robinson E, Dalzotto K, Limoli C, Jacobson T, Lee J, Slutzky MW. Myoelectric Computer Interface Training for Reducing Co-Activation and Enhancing Arm Movement in Chronic Stroke Survivors: A Randomized Trial. Neurorehabil Neural Repair. 2019 Apr;33(4):284-295. doi: 10.1177/1545968319834903. Epub 2019 Mar 19.

  • Seo G, Kishta A, Mugler E, Slutzky MW, Roh J. Myoelectric interface training enables targeted reduction in abnormal muscle co-activation. J Neuroeng Rehabil. 2022 Jul 1;19(1):67. doi: 10.1186/s12984-022-01045-z.

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Marc Slutzky, MD, PhD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Occupational Therapists were blinded to intervention group
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Neurology

Study Record Dates

First Submitted

June 28, 2018

First Posted

July 9, 2018

Study Start

July 1, 2014

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

April 13, 2026

Record last verified: 2026-04

Locations