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

Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · Mar 24, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at how a special wearable device called MyoPro can help people who have had a stroke regain movement in their weak arms. The MyoPro device uses signals from the muscles to help assist movement during therapy sessions. The study will compare the effects of using MyoPro along with therapy focused on learning new movements to therapy without the device. Researchers want to see if this combination is more effective for improving arm function in individuals who have had severe arm weakness for over six months after their stroke.

To participate in this study, you need to be between 18 and 89 years old and have weakness in one arm due to a stroke that happened at least six months ago. You also need to be able to move your shoulder a bit and have some muscle activity that the device can detect. If you meet these criteria, you could join the trial and receive specialized therapy sessions. Participants will be monitored closely and may undergo some additional tests to understand how well the treatment works. It's important to note that some people may not be eligible if they have certain medical conditions or past medical issues.

Gender

ALL

Eligibility 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.