Using a wearable exoskeleton to help stroke patients regain arm movement

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of combining motor learning-based therapy with the MyoPro, a myoelectrically controlled exoskeletal orthotic device, for individuals with severe upper limb motor deficits due to chronic stroke. Participants will engage in a randomized controlled trial to compare the outcomes of therapy with and without the MyoPro device. The study aims to assess not only the efficacy of this combined approach but also the underlying neuroplasticity mechanisms and cost-effectiveness of the intervention. The MyoPro assists movement by translating weak muscle signals into arm movement, potentially enhancing rehabilitation for those with limited ability to practice voluntary movements.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 18-89 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

Exclusion Criteria:

* 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.

Where it's running

• Louis Stokes VA Medical Center, Cleveland, OH
  Cleveland, Ohio, United States Recruiting

Study contacts

• Principal investigator: Svetlana Pundik, MD — Louis Stokes VA Medical Center, Cleveland, OH
• Study coordinator: Jessica P McCabe, MPT DPT
• Email: Jessica.Mccabe@va.gov
• Phone: (216) 791-3800

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.