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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Stroke, Acute
• Intervention / Treatment: Behavioral: MCI; Behavioral: Sham MCI

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marc W Slutzky, MD, PhD; Phone Number: 3125034653; Email: mslutzky@northwestern.edu
• Study Contact Backup: Name: Cynthia Gorski; Email: cynthia.gorski@northwestern.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chronic stroke MCI Electromyogram (EMG) pairs; Decoupling 2 muscles at a time with MCI	Behavioral: MCI; EMG-controlled game
Experimental: Chronic stroke MCI EMG triplets; Decoupling 3 muscles at a time with MCI	Behavioral: MCI; EMG-controlled game
Experimental: Chronic stroke MCI while reaching; Decoupling muscles with MCI while reaching to targets	Behavioral: MCI; EMG-controlled game
Sham Comparator: Chronic stroke Sham MCI; Sham control group	Behavioral: Sham MCI; Sham control game
Experimental: Acute stroke MCI; Decoupling muscles with MCI in acute stroke subjects	Behavioral: MCI; EMG-controlled game
Sham Comparator: Acute stroke Sham MCI; Acute stroke subjects sham comparator	Behavioral: Sham MCI; Sham control game

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wolf Motor Function Test	Timed	baseline to 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fugl-Meyer Assessment - Upper Extremity (UE)		baseline to 6 weeks
Motor Activity Log		baseline to 6 weeks
Modified Ashworth Scale	Total score	baseline to 6 weeks
Fugl-Meyer Assessment UE		baseline to 10 weeks
Wolf Motor Function Test	Timed	baseline to 10 weeks

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: National Institutes of Health (NIH); Shirley Ryan AbilityLab

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2018
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: January 9, 2018
• First Submitted That Met QC Criteria: January 9, 2018
• First Posted (Actual): January 17, 2018

Study Record Updates

• Last Update Posted (Actual): October 6, 2023
• Last Update Submitted That Met QC Criteria: October 4, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: rehabilitation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: STU00203644

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No