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Exoskeleton-assisted anthropomorphic movement training (EAMT) for poststroke upper limb rehabilitation: a pilot randomized controlled trial [with consumer summary]
Chen Z-J, He C, Guo F, Xiong C-H, Huang X-L
Archives of Physical Medicine and Rehabilitation 2021 Nov;102(11):2074-2082
clinical trial
8/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

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 (N = 20) due to a first-ever, unilateral, subacute stroke who had a score of 8 to 47 on the Fugl-Meyer Assessment for Upper Extremity (FMA-UE). INTERVENTIONS: 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 per week, for 4 weeks. MAIN OUTCOME MEASURES: Primary outcome: feasibility analysis. SECONDARY OUTCOMES: 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 determined to be safe, as no adverse event occurred except tolerable muscle fatigue in 2 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 controlled trials are warranted to confirm the results of this pilot study and explore the underlying mechanisms by which EAMT therapy might work.

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