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

Primary Purpose

Stroke, Stroke, Acute

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MCI
Sham MCI
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring rehabilitation

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Northwestern UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Sham Comparator

Experimental

Sham Comparator

Arm Label

Chronic stroke MCI Electromyogram (EMG) pairs

Chronic stroke MCI EMG triplets

Chronic stroke MCI while reaching

Chronic stroke Sham MCI

Acute stroke MCI

Acute stroke Sham MCI

Arm Description

Decoupling 2 muscles at a time with MCI

Decoupling 3 muscles at a time with MCI

Decoupling muscles with MCI while reaching to targets

Sham control group

Decoupling muscles with MCI in acute stroke subjects

Acute stroke subjects sham comparator

Outcomes

Primary Outcome Measures

Wolf Motor Function Test
Timed

Secondary Outcome Measures

Fugl-Meyer Assessment - Upper Extremity (UE)
Motor Activity Log
Modified Ashworth Scale
Total score
Fugl-Meyer Assessment UE
Wolf Motor Function Test
Timed

Full Information

First Posted
January 9, 2018
Last Updated
October 4, 2023
Sponsor
Northwestern University
Collaborators
Shirley Ryan AbilityLab, National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT03401762
Brief Title
Wearable MCI to Reduce Muscle Co-activation in Acute and Chronic Stroke
Official Title
Wearable MCI to Reduce Muscle Co-activation in Acute and Chronic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 15, 2018 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
Shirley Ryan AbilityLab, National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Stroke, Acute
Keywords
rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Participants will be blinded as to sham vs. intervention, but not as to which interventional arm.
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chronic stroke MCI Electromyogram (EMG) pairs
Arm Type
Experimental
Arm Description
Decoupling 2 muscles at a time with MCI
Arm Title
Chronic stroke MCI EMG triplets
Arm Type
Experimental
Arm Description
Decoupling 3 muscles at a time with MCI
Arm Title
Chronic stroke MCI while reaching
Arm Type
Experimental
Arm Description
Decoupling muscles with MCI while reaching to targets
Arm Title
Chronic stroke Sham MCI
Arm Type
Sham Comparator
Arm Description
Sham control group
Arm Title
Acute stroke MCI
Arm Type
Experimental
Arm Description
Decoupling muscles with MCI in acute stroke subjects
Arm Title
Acute stroke Sham MCI
Arm Type
Sham Comparator
Arm Description
Acute stroke subjects sham comparator
Intervention Type
Behavioral
Intervention Name(s)
MCI
Intervention Description
EMG-controlled game
Intervention Type
Behavioral
Intervention Name(s)
Sham MCI
Intervention Description
Sham control game
Primary Outcome Measure Information:
Title
Wolf Motor Function Test
Description
Timed
Time Frame
baseline to 6 weeks
Secondary Outcome Measure Information:
Title
Fugl-Meyer Assessment - Upper Extremity (UE)
Time Frame
baseline to 6 weeks
Title
Motor Activity Log
Time Frame
baseline to 6 weeks
Title
Modified Ashworth Scale
Description
Total score
Time Frame
baseline to 6 weeks
Title
Fugl-Meyer Assessment UE
Time Frame
baseline to 10 weeks
Title
Wolf Motor Function Test
Description
Timed
Time Frame
baseline to 10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marc W Slutzky, MD, PhD
Phone
3125034653
Email
mslutzky@northwestern.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Cynthia Gorski
Email
cynthia.gorski@northwestern.edu
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Citations:
PubMed Identifier
34415114
Citation
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.
Results Reference
derived

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

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