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

NCT05296408 | Recruiting DMC

• 1 other identifier: N3674-R
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Stroke

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Fugl Meyer for Upper Limb (FM) change

  Thirty-three items of movement coordination and reflex activity are scored with a 3-point Likert scale (0-66 points) where higher scores represent better arm function.

  weeks 1, 4, 9, 18 and 24

Secondary Outcomes (9)

• Modified Ashworth Scale (MAS)

  weeks 1, 4, 9, 18, 24

• Upper limb kinematics

  weeks 1, 4, 9, 18, 24

• Dynamometry

  weeks 1, 4, 9, 18, 24

• Arm Motor Ability Test

  weeks 1, 4, 9, 18, 24

• Stroke Impact Scale

  weeks 1, 4, 9, 18, 24

Study Arms (2)

M+ML

EXPERIMENTAL

MyoPro paired with motor learning based therapy

Behavioral: motor learning based therapy; Behavioral: MyoPro; Behavioral: Home Exercise Program

ML-alone

ACTIVE COMPARATOR

motor learning based therapy alone

Behavioral: motor learning based therapy; Behavioral: Home Exercise Program

Interventions

motor learning based therapy BEHAVIORAL

Motor learning based therapy will include functional task/task component training and will be employed to practice hand-to-mouth, forward reach, grasp-release, and object manipulation. Training will include high repetition both in the clinic and during home exercise practice. Tasks will be decomposed into component parts and practiced in this manner with the goal of returning to full task performance as skill develops Training will be tailored to each individual subject's capability and progressed according to a motor control hierarchy to ensure adequate challenge. Training is always started at the appropriate level of challenge for an individual to ensure adequate challenge is delivered whether the individual is higher or lower functioning.

M+ML; ML-alone

MyoPro BEHAVIORAL

The MyoPro supports motor learning-based training by reinforcing coordinated movement practice, allowing for finely incrementalized training progression, and encouraging high repetition of movement. Importantly, the device assists the user to move the paretic limb in a manner they may otherwise be unable to do. This further motivates the user to continue attempts to move the paretic limb. When a user attempts to volitionally contract a weak muscle, sensors embedded within the MyoPro detect the EMG signal, which triggers activation of a motor within the device. The motor assists the user to complete the desired movement (e.g. opening of the hand).Subjects experience real-time biofeedback through their ability to sense and see movement of the target joint(s) and via their interface with the software on a computer that provides visual feedback of the EMG level of the contracting muscle

M+ML

Home Exercise Program BEHAVIORAL

Every subject will be assigned an individualized HEP. Therapy staff will create written handouts for the user to follow. The HEP will include photographs of the study participant performing his/her exercises/functional tasks along with written instructions. Each individual will have their own personalized HEP that will be created during their study participation and will be dispensed only to them. The HEP will reinforce in-clinic therapy. The HEP will be progressed regularly, and individuals will log practice time. The HEP for M+ML will include practice with and without the MyoPro; the HEP for ML-alone will include practice without MyoPro. Each HEP session will require approximately 90 minutes to complete.

M+ML; ML-alone

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• Unilateral arm weakness due to stroke (6 months or more since onset)
• Adequate range of motion at the elbow, forearm, wrist, and hand to don the device
• Active shoulder flexion of at least 30 degrees and active shoulder abduction of at least 20 degrees
• 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
• MAS score less or equal to 3 for the biceps, triceps, supinators and pronators of the impaired arm
• Able to read and comprehend the English language
• Able to follow directions
• Able to provide informed consent
• Medically and psychologically stable.
• Ability to don/doff MyoPro independently or have support as needed.
• Ability to undergo MRI
• Ability to undergo TMS procedures

You may not qualify if:

• Previous stroke(s) affecting motor function on the opposite side.
• Persistent and severe shoulder subluxation, pain or dislocation
• Shoulder passive range of motion \< 45 degrees in flexion and abduction
• Fixed upper limb contractures on the impaired arm and hand
• 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.
• Skin rash or open non-healing wound on impaired arm
• Involuntary movements of the impaired arm
• Pacemaker or other implanted devices that are not compatible with testing procedures or would interfere with donning/doffing and functioning of device.
• Metal in the skull or deformity of the skull
• Claustrophobia, or inability to operate the MRI patient call button
• Contraindications for MRI (standardized screening form for MRI).
• Past history of seizures
• Family history of medication refractory epilepsy
• Pregnancy or pregnancy planning during the study period
• Currently taking medications or substances that lower the threshold for onset of seizure.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, 44106-1702, United States

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Svetlana Pundik, MD

  Louis Stokes VA Medical Center, Cleveland, OH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica P McCabe, MPT DPT

CONTACT

(216) 791-3800; Jessica.Mccabe@va.gov

Svetlana Pundik, MD

CONTACT

(216) 791-3800; svetlana.pundik@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A blinded assessor will collect clinical outcomes
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Individuals will be randomized to either receive motor learning combined with Myopro (M+ML) or motor learning alone (ML-alone)

Study Record Dates

• First Submitted: March 9, 2022
• First Posted: March 25, 2022
• Study Start: April 1, 2022
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)