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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-89
SponsorVA Office of Research and Development

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • motor learning based therapy
  • MyoPro
  • Home Exercise Program

Treatment groups

60 Participants
are divided into 2 treatment groups