Zejian Chen1,2, Nan Xia1,2, Chang He3, Minghui Gu1,2, Jiang Xu1,2, Xiaohua Han4,5, Xiaolin Huang6,7. 1. Department of Rehabilitation Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. 2. World Health Organization Cooperative Training and Research Center in Rehabilitation, Wuhan, China. 3. Institute of Rehabilitation and Medical Robotics, State Key Lab of Digital Manufacturing Equipment and Technology, Huazhong University of Science and Technology, Wuhan, China. 4. Department of Rehabilitation Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. hanxiao1470@hust.edu.cn. 5. World Health Organization Cooperative Training and Research Center in Rehabilitation, Wuhan, China. hanxiao1470@hust.edu.cn. 6. Department of Rehabilitation Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. xiaolinh2006@126.com. 7. World Health Organization Cooperative Training and Research Center in Rehabilitation, Wuhan, China. xiaolinh2006@126.com.
Abstract
BACKGROUND: 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. 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. METHODS: The 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. DISCUSSION: This 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 REGISTRATION: Chinese Clinical Trial Registry ChiCTR1900026656 . Registered on 17 October 2019.
RCT Entities:
BACKGROUND: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. 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. METHODS: The 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 strokepatients 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. DISCUSSION: This 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 REGISTRATION: Chinese Clinical Trial Registry ChiCTR1900026656 . Registered on 17 October 2019.
Authors: Carolee J Winstein; Joel Stein; Ross Arena; Barbara Bates; Leora R Cherney; Steven C Cramer; Frank Deruyter; Janice J Eng; Beth Fisher; Richard L Harvey; Catherine E Lang; Marilyn MacKay-Lyons; Kenneth J Ottenbacher; Sue Pugh; Mathew J Reeves; Lorie G Richards; William Stiers; Richard D Zorowitz Journal: Stroke Date: 2016-05-04 Impact factor: 7.914
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