Action observation treatment-based exoskeleton (AOT-EXO) for upper extremity after stroke: study protocol for a randomized controlled trial

Abstract Background Stroke produces multiple symptoms, including sensory, motor, cognitive and psychological dysfunctions, among which motor deficit is the most common widely recognized as a major contributor to long-term functional disability. Robot-assisted training effective in promoting upper extremity muscle strength impairment recovery after stroke. Additionally, action observation treatment can enhance effects of physical occupational therapy by increasing neural activation. The AOT-EXO trial aims investigate whether coupled with robot-assisted could circuit activation improve outcomes. Methods multicentre, prospective, three-group randomized controlled (RCT). We will screen enrol 132 eligible patients implemented Department Rehabilitation Medicine Tongji Hospital, Optical Valley Branch Hospital Hubei Province Integrated Chinese & Western Wuhan, China. Prior study participation, written informed consent be obtained from accordance Declaration Helsinki. enrolled stroke three groups: CT group (conventional therapy); EXO (exoskeleton therapy) (action treatment-based exoskeleton therapy). undergo blinded assessments at baseline, post-intervention (after 4 weeks) follow-up 12 weeks). primary outcome Fugl-Meyer Assessment for Upper Extremity (FMA-UE). Secondary outcomes include Action Research Arm Test (ARAT), modified Barthel Index (MBI), kinematic metrics assessed inertial measurement unit (IMU), resting threshold (rMT), evoked potentials (MEP), magnetic resonance imaging (fMRI) safety Discussion This provide evidence regarding feasibility efficacy (AOT-EXO) post-stroke rehabilitation elucidate potential underlying neurological mechanisms. Trial registration Clinical Registry ChiCTR1900026656 . Registered on 17 October 2019.