外骨骼可穿戴机器人在脑卒中患者步行功能中的应用：一项国际多中心随机对照研究方案。

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

机构信息

Department of Physical and Rehabilitation Medicine, Center for Prevention and Rehabilitation, Heart Vascular and Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea (the Republic of).

National Traffic Injury Rehabilitation Hospital, Gyeonggi-do, Korea (the Republic of).

出版信息

BMJ Open. 2023 Aug 11;13(8):e065298. doi: 10.1136/bmjopen-2022-065298.

DOI:10.1136/bmjopen-2022-065298

PMID:37567748

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10423773/

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.

摘要

简介

本研究旨在确定使用外骨骼可穿戴机器人（外骨骼）进行地面步态训练对亚急性脑卒中患者步行功能恢复的影响。我们还研究了外骨骼对亚急性脑卒中患者步行功能的辅助作用。

方法和分析

这是一项在五家机构进行的国际多中心随机对照研究，共有 150 名亚急性脑卒中患者参与。参与者将被随机分为两组（机器人辅助步态训练（RAGT）组 75 例，对照组 75 例）。步态训练共进行 20 次（每次 60 分钟）；每周 5 次，持续 4 周。RAGT 组将接受 30 分钟外骨骼（Angel Robotics 的 ANGEL LEGS M20）辅助步态训练和 30 分钟常规步态训练，而对照组将接受 60 分钟常规步态训练。所有患者在干预前后均进行步行、运动和平衡等功能评估。进行随访监测，以验证患者是否能在 3 个月内无需身体辅助行走。主要结局是步态训练后功能性步行分类的改善。RAGT 组的最后一次训练结束后，立即对其进行功能评估，以评估外骨骼可穿戴机器人的辅助效果。本试验将为外骨骼改善和辅助亚急性脑卒中患者步行功能提供证据。