motor learning based therapy for Stroke, Chronic

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Stroke, Chronicmotor learning based therapy - Behavioral
Eligibility
18 - 89
All Sexes
What conditions do you have?
Select

Study Summary

This trial will study the effects of combining motor learning-based therapy with the MyoPro, a wearable exoskeletal device that uses EMG signals to assist movement of the user's affected arm. The objective is to study the efficacy of using MyoPro in motor learning-based therapy for individuals with chronic stroke compared with motor learning-based therapy alone.

Eligible Conditions
  • Stroke, Chronic

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: weeks 1, 4, 9, 18, 24

week 1 and 18
Brain network connectivity using resting state functional Magnetic Resonance Imaging (rs-fMRI)
Fractional anisotropy of movement-related tracts
Week 1
Fugl Meyer for Upper Limb (FM) change
Week 1
Arm Motor Ability Test
Dynamometry
Modified Ashworth Scale (MAS)
Stroke Impact Scale
Transcranial Magnetic Stimulation (TMS)
Upper limb kinematics
Week 1
Short Form 12v12

Trial Safety

Trial Design

2 Treatment Groups

ML-alone
1 of 2
M+ML
1 of 2

Active Control

Experimental Treatment

60 Total Participants · 2 Treatment Groups

Primary Treatment: motor learning based therapy · No Placebo Group · N/A

M+MLExperimental Group · 3 Interventions: motor learning based therapy, MyoPro, Home Exercise Program · Intervention Types: Behavioral, Behavioral, Behavioral
ML-aloneActiveComparator Group · 2 Interventions: motor learning based therapy, Home Exercise Program · Intervention Types: Behavioral, Behavioral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Home Exercise Program
2019
Completed Phase 3
~640

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: weeks 1, 4, 9, 18, 24

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,485 Previous Clinical Trials
2,742,159 Total Patients Enrolled
1 Trials studying Stroke, Chronic
60 Patients Enrolled for Stroke, Chronic
Svetlana Pundik, MDPrincipal InvestigatorLouis Stokes VA Medical Center, Cleveland, OH
2 Previous Clinical Trials
70 Total Patients Enrolled

Eligibility Criteria

Age 18 - 89 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have the ability to generate volitional, consistent, and detectable EMG signals from the upper arm and forearm sensor sites with wrist in neutral or flexed positions as detected by the MyoPro software.
You are 18-89 years old.
You have weakness in one arm.
You have a range of motion at the elbow, forearm, wrist, and hand that is appropriate for the device.
You have active shoulder flexion of at least 30 degrees and active shoulder abduction of at least 20 degrees.
You are able to follow directions.