RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study will evaluate the effects of combining motor learning-based therapy with use of the MyoPro , a wearable exoskeletal myoelectrically controlled orthotic device. MyoPro uses electromyographic (EMG) signals from the weak muscles to assist movement of the user's affected arm. The primary objective of this randomized controlled trial is to study the efficacy of using MyoPro in motor learning-based therapy for individuals with chronic stroke (\>6 months post) with severe upper limb motor deficits (Fugl-Meyer for Upper Limb score less than 30) compared with a similar dose of motor learning-based therapy alone. The secondary objectives are to evaluate neuroplasticity mechanisms, identify biomarkers of greater response to the intervention, and explore cost-effectiveness.

Official Title

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

Quick Facts

Study Start:2022-04-01
Study Completion:2026-04-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05296408

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 89 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18-89 years of age
  2. * Unilateral arm weakness due to stroke (6 months or more since onset)
  3. * Adequate range of motion at the elbow, forearm, wrist, and hand to don the device
  4. * Active shoulder flexion of at least 30 degrees and active shoulder abduction of at least 20 degrees
  5. * 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
  6. * MAS score less or equal to 3 for the biceps, triceps, supinators and pronators of the impaired arm
  7. * Able to read and comprehend the English language
  8. * Able to follow directions
  9. * Able to provide informed consent
  10. * Medically and psychologically stable.
  11. * Ability to don/doff MyoPro independently or have support as needed.
  12. * Ability to undergo MRI
  13. * Ability to undergo TMS procedures
  1. * Previous stroke(s) affecting motor function on the opposite side.
  2. * Persistent and severe shoulder subluxation, pain or dislocation
  3. * Shoulder passive range of motion \< 45 degrees in flexion and abduction
  4. * Fixed upper limb contractures on the impaired arm and hand
  5. * Unable to safely support the weight of their arm plus 4 lbs (1.82 kg; the weight of the device) without pain even with arm supported.
  6. * Skin rash or open non-healing wound on impaired arm
  7. * Involuntary movements of the impaired arm
  8. * Pacemaker or other implanted devices that are not compatible with testing procedures or would interfere with donning/doffing and functioning of device.
  9. * Metal in the skull or deformity of the skull
  10. * Claustrophobia, or inability to operate the MRI patient call button
  11. * Contraindications for MRI (standardized screening form for MRI).
  12. * Past history of seizures
  13. * Family history of medication refractory epilepsy
  14. * Pregnancy or pregnancy planning during the study period
  15. * Currently taking medications or substances that lower the threshold for onset of seizure.

Contacts and Locations

Study Contact

Jessica P McCabe, MPT DPT
CONTACT
(216) 791-3800
Jessica.Mccabe@va.gov
Svetlana Pundik, MD
CONTACT
(216) 791-3800
svetlana.pundik@va.gov

Principal Investigator

Svetlana Pundik, MD
PRINCIPAL_INVESTIGATOR
Louis Stokes VA Medical Center, Cleveland, OH

Study Locations (Sites)

Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, 44106-1702
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Svetlana Pundik, MD, PRINCIPAL_INVESTIGATOR, Louis Stokes VA Medical Center, Cleveland, OH

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-01
Study Completion Date2026-04-01

Study Record Updates

Study Start Date2022-04-01
Study Completion Date2026-04-01

Terms related to this study

Keywords Provided by Researchers

  • stroke
  • rehabilitation
  • upper limb
  • motor learning
  • cerebrovascular accident

Additional Relevant MeSH Terms

  • Chronic Stroke