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MyoPro-Assisted Therapy for Stroke

N/A

Recruiting

Led By Svetlana Pundik, MD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ability to undergo TMS procedures

Active shoulder flexion of at least 30 degrees and active shoulder abduction of at least 20 degrees

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weeks 1, 4, 9, 18, 24

Awards & highlights

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.

Who is the study for?

Adults aged 18-89 with severe arm weakness from a stroke that happened at least 6 months ago can join. They must be able to move their shoulder a bit, wear the MyoPro device, and produce muscle signals it can read. People with metal in their skull, pacemakers, or conditions like seizures or claustrophobia that make MRI scans unsafe cannot participate.Check my eligibility

What is being tested?

The trial is testing if using the MyoPro exoskeleton along with motor learning therapy helps people recover arm function after a chronic stroke better than therapy alone. It also looks into how the brain changes during recovery and which patients benefit most.See study design

What are the potential side effects?

Possible side effects may include discomfort wearing MyoPro, skin irritation under the device, fatigue from exercises, and any risks typically associated with MRI and TMS procedures used for evaluation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can undergo TMS (Transcranial Magnetic Stimulation) procedures.

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I can lift my arm forward at least 30 degrees and to the side at least 20 degrees.

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I can move my elbow, forearm, wrist, and hand well enough to use the device.

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I can use or have help to use the MyoPro device by myself.

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I am between 18 and 89 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 1, 4, 9, 18, 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weeks 1, 4, 9, 18, 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 1, 4, 9, 18, 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Fugl Meyer for Upper Limb (FM) change

Secondary outcome measures

Arm Motor Ability Test

Brain network connectivity using resting state functional Magnetic Resonance Imaging (rs-fMRI)

Dynamometry

+6 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: M+MLExperimental Treatment3 Interventions

MyoPro paired with motor learning based therapy

Group II: ML-aloneActive Control2 Interventions

motor learning based therapy alone

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Home Exercise Program

2019

Completed Phase 3

~760

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,609 Previous Clinical Trials

3,306,393 Total Patients Enrolled

84 Trials studying Stroke

6,718 Patients Enrolled for Stroke

Svetlana Pundik, MDPrincipal InvestigatorLouis Stokes VA Medical Center, Cleveland, OH

3 Previous Clinical Trials

105 Total Patients Enrolled

2 Trials studying Stroke

65 Patients Enrolled for Stroke

Media Library

Motor Learning-Based Therapy Clinical Trial Eligibility Overview. Trial Name: NCT05296408 — N/A

Stroke Research Study Groups: M+ML, ML-alone

Stroke Clinical Trial 2023: Motor Learning-Based Therapy Highlights & Side Effects. Trial Name: NCT05296408 — N/A

Motor Learning-Based Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05296408 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many research participants are taking part in the experiment?

"Affirmative. Clinicaltrials.gov has a listing for this research project, which was initially advertised on April 1st 2022 and is currently searching for 60 volunteers from one medical center."

Answered by AI

Could individuals aged 65 years and older participate in this experiment?

"Patients aged 18-89 can take part in this medical trial. Additionally, there are 38 trials available for minors and 1008 that cater to the elderly population."

Answered by AI

Could I potentially become a participant in this medical investigation?

"This clinical trial is enrolling 60 people of ages 18-89 who have suffered a stroke. In order to be considered eligible, participants must satisfy the following criteria: possess MyoPro software that can detect volitional and consistent EMG signals from their upper arm/forearm sensor sites, show active shoulder flexion >30 degrees and abduction >20 degrees with wrist in neutral or flexed positions, demonstrate no more than 3 points on MAS for biceps, triceps supinators & pronators of affected limb; plus read & comprehend English language instructions as well as provide informed consent. Additionally they must be medically and psychologically stable."

Answered by AI

Is there an open enrollment period for participants in this experiment?

"Affirmative, the information hosted on clinicaltrials.gov suggests that this experimental research project is still actively seeking participants. It was initially posted on April 1st 2022 and has since been updated, with a current goal of recruiting 60 individuals from one location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Exoskeleton Research: Myoelectric Orthosis for Rehab of Severe Chronic Arm Motor Deficits

2022. "Exoskeleton Research: Myoelectric Orthosis for Rehab of Severe Chronic Arm Motor Deficits". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05296408.