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Research Article: Exoskeletal wearable robot on ambulatory function in patients with stroke: a protocol for an international, multicentre, randomised controlled study

Date Published: 2023-08-11

Abstract:
Introduction The purpose of this study is to determine the effect of overground gait training using an exoskeletal wearable robot (exoskeleton) on the recovery of ambulatory function in patients with subacute stroke. We also investigate the assistive effects of an exoskeleton on ambulatory function in patients with subacute stroke. Methods and analysis This study is an international, multicentre, randomised controlled study at five institutions with a total of 150 patients with subacute stroke. Participants will be randomised into two groups (75 patients in the robot-assisted gait training (RAGT) group and 75 patients in the control group). The gait training will be performed with a total of 20 sessions (60?min/session); 5 sessions a week for 4?weeks. The RAGT group will receive 30?min of gait training using an exoskeleton (ANGEL LEGS M20, Angel Robotics) and 30?min of conventional gait training, while the control group will receive 60?min conventional gait training. In all the patients, the functional assessments such as ambulation, motor and balance will be evaluated before and after the intervention. Follow-up monitoring will be performed to verify whether the patient can walk without physical assistance for 3?months. The primary outcome is the improvement of the Functional Ambulatory Category after the gait training. The functional assessments will also be evaluated immediately after the last training session in the RAGT group to assess the assistive effects of an exoskeletal wearable robot. This trial will provide evidence on the effects of an exoskeleton to improve and assist ambulatory function in patients with subacute stroke. Ethics and dissemination This protocol has been approved by the Institutional Review Board of each hospital and conforms to the Declaration of Helsinki. The results will be disseminated through publication. Trial registration number Protocol was registered at ClinicalTrials.gov ( NCT05157347 ) on 15 December 2021 and CRIS (KCT0006815) on 19 November 2021.

Introduction:
Stroke is reported as one of the leading causes of disability in adults. 1 Recent advances in hyperacute and acute management have led to a significant impact on clinical and functional outcomes of patients with stroke. 2 3 However, hyperacute management such as revascularisation therapy can only be applied to a limited population of patients with stroke 2 and many patients with stroke are still suffering from significant motor impairments and gait disturbance. 1 Especially, the recovery of the ambulatory function…

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