Ze-Jian Chen1, Chang He2, Feng Guo1, Cai-Hua Xiong2, Xiao-Lin Huang3. 1. Department of Rehabilitation Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei Province, People's Republic of China; World Health Organization Cooperative Training and Research Center in Rehabilitation, Wuhan, Hubei Province, People's Republic of China. 2. Institute of Rehabilitation and Medical Robotics, State Key Lab of Digital Manufacturing Equipment and Technology, Huazhong University of Science and Technology, Wuhan, Hubei Province, People's Republic of China. 3. Department of Rehabilitation Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei Province, People's Republic of China; World Health Organization Cooperative Training and Research Center in Rehabilitation, Wuhan, Hubei Province, People's Republic of China. Electronic address: xiaolinh2006@126.com.
Abstract
OBJECTIVE: To investigate the feasibility of exoskeleton-assisted anthropomorphic movement training (EAMT) and its effects on upper extremity motor impairment, function and kinematics after stroke. DESIGN: A single-blind pilot randomized controlled trial. SETTING:Stroke rehabilitation inpatient unit. PARTICIPANTS: Participants with a hemiplegia due to a first-ever, unilateral, subacute stroke who had a score of 8 to 47 on the Fugl-Meyer Assessment for Upper Extremity. INTERVENTION: The exoskeleton group received EAMT therapy that provided task-specific training under anthropomorphic trajectories and postures. The control group received conventional upper limb therapy. For both groups, therapy was delivered at the same intensity, frequency and duration: 45 minutes daily, 5 days/week for 4 weeks. MAIN OUTCOME MEASURES: Primary outcome: Feasibility Analysis. SECONDARY OUTCOMES: Fugl-Meyer Assessment for Upper Extremity (FMA-UE), Action Research Arm Test (ARAT), modified Barthel Index (MBI), and kinematic metrics during exoskeleton therapy. RESULTS:Twenty participants with subacute stroke were recruited and completed all therapy sessions. EAMT therapy was feasible and acceptable for the participants. The recruitment rate, retention rate and number of therapists required for EAMT therapy were acceptable compared with other robotic trials. EAMT was safe as no adverse event occurred except tolerable muscle fatigue in two participants. There were significant between-group differences in the change scores of FMA-UE (difference, 4.30 points; P=0.04) and MBI (difference, 8.70 points; P=0.03) in favor of EAMT therapy. No significant between-group difference was demonstrated for the change scores of ARAT (P=0.18). Participants receiving EAMT showed significant improvements in kinematic metrics after treatment (P<0.01). CONCLUSIONS: Our results indicate that EAMT is a feasible approach and may improve upper extremity motor impairment, activities of daily living and kinematics after stroke. However, fully powered randomized clinical trials are warranted to confirm the results of this pilot study and explore the underlying mechanisms by which EAMT therapy might work.
RCT Entities:
OBJECTIVE: To investigate the feasibility of exoskeleton-assisted anthropomorphic movement training (EAMT) and its effects on upper extremity motor impairment, function and kinematics after stroke. DESIGN: A single-blind pilot randomized controlled trial. SETTING:Stroke rehabilitation inpatient unit. PARTICIPANTS: Participants with a hemiplegia due to a first-ever, unilateral, subacute stroke who had a score of 8 to 47 on the Fugl-Meyer Assessment for Upper Extremity. INTERVENTION: The exoskeleton group received EAMT therapy that provided task-specific training under anthropomorphic trajectories and postures. The control group received conventional upper limb therapy. For both groups, therapy was delivered at the same intensity, frequency and duration: 45 minutes daily, 5 days/week for 4 weeks. MAIN OUTCOME MEASURES: Primary outcome: Feasibility Analysis. SECONDARY OUTCOMES: Fugl-Meyer Assessment for Upper Extremity (FMA-UE), Action Research Arm Test (ARAT), modified Barthel Index (MBI), and kinematic metrics during exoskeleton therapy. RESULTS: Twenty participants with subacute stroke were recruited and completed all therapy sessions. EAMT therapy was feasible and acceptable for the participants. The recruitment rate, retention rate and number of therapists required for EAMT therapy were acceptable compared with other robotic trials. EAMT was safe as no adverse event occurred except tolerable muscle fatigue in two participants. There were significant between-group differences in the change scores of FMA-UE (difference, 4.30 points; P=0.04) and MBI (difference, 8.70 points; P=0.03) in favor of EAMT therapy. No significant between-group difference was demonstrated for the change scores of ARAT (P=0.18). Participants receiving EAMT showed significant improvements in kinematic metrics after treatment (P<0.01). CONCLUSIONS: Our results indicate that EAMT is a feasible approach and may improve upper extremity motor impairment, activities of daily living and kinematics after stroke. However, fully powered randomized clinical trials are warranted to confirm the results of this pilot study and explore the underlying mechanisms by which EAMT therapy might work.