Feasibility and Safety Evaluation of Hybrid Assistive Limb-Based Neurorehabilitation for Patients with Central Motor Dysfunction: A Single-Center Study.

Abstract

Objective Motor impairments caused by central nervous system (CNS) disorders lead to significant loss of functional independence in activities of daily living. The Hybrid Assistive Limb (HAL) is a wearable robotic device that augments voluntary movement and promotes CNS recovery via interactive biofeedback. We aimed to evaluate the feasibility and safety of HAL-assisted rehabilitation across inpatient and outpatient settings in patients with diverse CNS disorders. Design Non-randomized, single-arm study SETTING: Single-center study PARTICIPANTS: This study enrolled 229 patients with CNS-related motor impairment between July 2014 and March 2024. Interventions Participants received HAL-assisted rehabilitation using bilateral-leg, single-leg, or single-joint HAL devices based on their clinical presentation. Main outcome measures The primary outcomes were feasibility and safety, evaluated by adverse event profile, treatment discontinuation rates, intervention exposure (duration and session frequency), and applicability. Results In total, 238 HAL intervention episodes were analyzed (229 patients; mean age, 54.1 ± 20.1 years). No serious adverse events were identified. At least one adverse event occurred in 20 of 238 intervention episodes (8.4%), comprising a total of 23 adverse events. All events were mild and resolved with conservative management or observation without the permanent discontinuation of HAL therapy. The mean number of HAL sessions was 10.5 ± 9.5, with a mean intervention duration of 105.9 ± 163.4 days. The frequency of intervention episodes with adverse events differed significantly according to diagnostic category and HAL device type but not according to the clinical setting. HAL-assisted rehabilitation was successfully implemented across multiple CNS disorders in inpatient and outpatient settings, demonstrating clinical feasibility in heterogeneous rehabilitation settings. Conclusion HAL-assisted rehabilitation was associated with no serious adverse events and a low incidence of minor adverse events. These findings indicated an acceptable safety profile and supported the feasibility of HAL-assisted rehabilitation across diverse CNS disorders and care settings.