Abstract
Exoskeletons have been proposed for potential clinical use to improve ambulatory function in patients with stroke. The aim of an interim analysis of an international, multicenter, randomized, controlled trial was to investigate the short-term effect of overground gait training using a torque-assisted exoskeleton in subacute stroke patients with severe ambulatory functional impairment. Data from a total of 93 subacute stroke patients with severe ambulatory functional impairment were analyzed. All participants received a total of 20 sessions; five sessions per week for 4 weeks. The robot-assisted gait training (RAGT) group received 30 min of conventional gait training and 30 min of gait training using an exoskeleton (ANGEL LEGS M20, Angel robotics, Co., Ltd.), while the control group received 60 min of conventional gait training. Functional assessments were conducted before and immediately after the final intervention by a rater blinded to group assignment. Overground gait training with a torque-assisted exoskeleton in this study showed improvement in gait function comparable to conventional gait rehabilitation in subacute stroke patients, with additional gains in lower extremity strength. These findings suggest that the overground gait training with a torque-assisted exoskeleton might be a potential intervention for subacute stroke patients.Clinical Trial Registration: NCT05157347 (the first registration (10/12/2021)).