Using a wearable exoskeleton to help stroke patients regain arm movement
Exoskeleton Research: Myoelectric Orthosis for Rehab of Severe Chronic Arm Motor Deficits
This study is testing if using a special arm device called MyoPro along with therapy can help stroke patients regain movement in their arms better than therapy alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT05296408 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-89 with unilateral arm weakness due to stroke occurring more than six months prior and who can generate detectable EMG signals.
Not a fit: Patients with previous strokes affecting the opposite side or those with severe shoulder impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve arm function and quality of life for stroke survivors with severe motor deficits.
How similar studies have performed: Preliminary results from similar approaches using the MyoPro have shown promising improvements in arm function, indicating potential success for this study.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Cleveland, Ohio
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.