Abstract
BackgroundStroke produces multiple symptoms, including sensory, motor, cognitive and psychological dysfunctions, among which motor deficit is the most common and is widely recognized as a major contributor to long-term functional disability. Robot-assisted training is effective in promoting upper extremity muscle strength and motor impairment recovery after stroke. Additionally, action observation treatment can enhance the effects of physical and occupational therapy by increasing neural activation. The AOT-EXO trial aims to investigate whether action observation treatment coupled with robot-assisted training could enhance motor circuit activation and improve upper extremity motor outcomes.MethodsThe AOT-EXO trial is a multicentre, prospective, three-group randomized controlled trial (RCT). We will screen and enrol 132 eligible patients in the trial implemented in the Department of Rehabilitation Medicine of Tongji Hospital, Optical Valley Branch of Tongji Hospital and Hubei Province Hospital of Integrated Chinese & Western Medicine in Wuhan, China. Prior to study participation, written informed consent will be obtained from eligible patients in accordance with the Declaration of Helsinki. The enrolled stroke patients will be randomized to three groups: the CT group (conventional therapy); EXO group (exoskeleton therapy) and AOT-EXO group (action observation treatment-based exoskeleton therapy). The patients will undergo blinded assessments at baseline, post-intervention (after 4 weeks) and follow-up (after 12 weeks). The primary outcome will be the Fugl-Meyer Assessment for Upper Extremity (FMA-UE). Secondary outcomes will include the Action Research Arm Test (ARAT), modified Barthel Index (MBI), kinematic metrics assessed by inertial measurement unit (IMU), resting motor threshold (rMT), motor evoked potentials (MEP), functional magnetic resonance imaging (fMRI) and safety outcomes.DiscussionThis trial will provide evidence regarding the feasibility and efficacy of the action observation treatment-based exoskeleton (AOT-EXO) for post-stroke upper extremity rehabilitation and elucidate the potential underlying kinematic and neurological mechanisms.Trial registrationChinese Clinical Trial Registry ChiCTR1900026656. Registered on 17 October 2019.
Highlights
Stroke produces multiple symptoms, including sensory, motor, cognitive and psychological dysfunctions, among which motor deficit is the most common and is widely recognized as a major contributor to long-term functional disability
We hypothesize that action observation treatment coupled with robot-assisted training may enhance motor circuit activation and improve upper extremity motor outcomes
In this study, we aim to evaluate the effects of action observation treatment-based exoskeleton (AOT-EXO) treatment for the upper extremity after stroke and to explore the potential kinematic mechanisms assessed by inertial measurement unit (IMU) and neurological mechanisms using functional magnetic resonance imaging and corticospinal excitability metrics
Summary
Stroke produces multiple symptoms, including sensory, motor, cognitive and psychological dysfunctions, among which motor deficit is the most common and is widely recognized as a major contributor to long-term functional disability. Stroke produces numerous symptoms, including sensory, motor, cognitive and psychological dysfunctions, among which motor deficit is the most common and is widely recognized as a major contributor to long-term functional disability [2, 3]. Over the last several decades, various rehabilitation approaches have been developed to promote upper extremity motor recovery, functional performance and quality of life in stroke patients [5, 6] These novel approaches are commonly predicated on the principles of motor learning and taskspecific training to facilitate motor neural network plasticity [7,8,9]. Robotic devices can be programmed simultaneously with other techniques in the adaptive, motivational and quantifiable training methods for boosting neuroplasticity [14]
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