Efficacy and safety of using a unilateral lower limb exoskeleton in neurorehabilitation: a randomized controlled trial

Abstract

Background Stroke remains the leading cause of both mortality and disability globally. Recovery of limb function in patients with stroke is usually poor and requires an extended period. Consequently, rehabilitation technology in stroke has gained attention. A unilateral lower limb exoskeleton (ULLE), which has an intelligent relearning feature that promotes active engagement of the patient’s brain in controlling of encouraging a patient to actively use their brain to control the unaffected limb to lead the interactive movement of both limbs, thereby achieving individualized bilateral combined functional training, was recently developed to be used in patients with hemiplegia after stroke or traumatic brain injury. However, data on the efficacy and safety of ULLE in patients with stroke are scarce. We aimed to assess the effectiveness and safety of the LiteStepper® ULLE in gait training of patients with post-stroke hemiplegia. Methods This study was a multicenter, optimal, open, loaded, randomized controlled trial. Overall, 92 patients in their post-stroke phase from Hangzhou First People’s Hospital, The Second Affiliated Hospital Zhejiang University School of Medicine, The First Hospital of Jiaxing, and The Fifth Affiliated Hospital of Zhengzhou University were enrolled in this study. The experimental group (EG) adopted the LiteStepper® ULLE based on a once-daily 21-day routine rehabilitation. The conventional group (CG) only underwent the once-daily 21-day routine rehabilitation. Results The efficacy analysis outcomes (Berg balance scale, Functional Ambulation Category scale, 6-minute walking distance, and Barthel Index) between EG and CG had significant differences (P < 0.05) (analyzed using full analysis and per protocol sets). EG showed better improvements than CG (lower limit value [EG-CG] > 2). Safety analysis showed that only one adverse event related to the device occurred during the study, which verified the safety of using the ULLE for gait training in patients after stroke. Conclusions The LiteStepper®ULLE is effective and safe for gait training in patients after stroke. Trial registration ClinicalTrials.gov identifier: NCT05360017