与传统物理治疗相比，使用髋部外骨骼辅助（HEXA）机器人对偏瘫中风患者临床功能结局的影响：一项前瞻性随机对照试验。

The effect of using the hip exoskeleton assistive (HEXA) robot compared to conventional physiotherapy on clinical functional outcomes in stroke patients with hemiplegia: a pilot randomized controlled trial.

作者信息

Mamipour Hamed, Hoseini Seyed Ali, Negahban Hossein, Moradi Ali, Hojjati Amir, Rezaeitalab Fariborz, Torshizian Mohammadreza, Mehrali Arefeh, Parsa Mohammad, Kardan Iman, Tabesh Hamed, Hassankhani Ebrahim Ghayem, Akbarzadeh Alireza

机构信息

Department of Physical Therapy, School of Paramedical and Rehabilitation Sciences, Mashhad University of Medical Sciences, Mashhad, Iran.

Orthopedic Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.

出版信息

BMC Biomed Eng. 2024 Aug 1;6(1):7. doi: 10.1186/s42490-024-00082-0.

DOI:10.1186/s42490-024-00082-0

PMID:39085924

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11293188/

Abstract

TRIAL DESIGN

This study is a pilot randomized clinical trial aimed to investigate the effect of using Hip Exoskeleton Assistive (HEXA) robot compared to conventional physiotherapy on the quality of walking, disability, and quality of life of stroke patients with hemiplegia.

METHODS

In this study, 24 patients were randomly assigned to the intervention group (robotic physiotherapy with HEXA robot), or control group (conventional physiotherapy). In each session, both groups received 30 min of conventional physiotherapy including electrotherapy and conventional exercises, and then the intervention group did gait training for 30 min with the HEXA robot and the control group for 30 min without the HEXA robot. The treatment program was 12 sessions, 3 times a week. Before the 1st and after the 12th sessions, both groups were evaluated for walking quality, disability, and quality of life.

RESULTS

The results showed that the main effect of time was significant (P < 0.05) in all outcomes and patients in both groups achieved significant improvement in all outcomes after the intervention. The main effect of the group was also significant in the outcomes of 6MWT (P < 0.05) and TUG (P < 0.05), and the intervention group patients experienced more distance and speed in these two tests. This study was approved by the ethics committee of Mashhad University of Medical Sciences (IR.MUMS.FHMPM.REC.1400.079 dated 28th Jan 2022). The trial was registered with the clinical trials site of www.IRCT.ir (IRCT20210730052024N1) on January 28th 2022.

CONCLUSION

It seems that the HEXA robot can effectively improve walking capacity and speed.

摘要

试验设计

本研究是一项前瞻性随机临床试验，旨在探究与传统物理治疗相比，使用髋关节外骨骼辅助（HEXA）机器人对偏瘫中风患者步行质量、残疾程度和生活质量的影响。

方法

在本研究中，24名患者被随机分配至干预组（使用HEXA机器人进行机器人物理治疗）或对照组（传统物理治疗）。在每次治疗中，两组均接受30分钟的传统物理治疗，包括电疗法和传统运动，然后干预组使用HEXA机器人进行30分钟的步态训练，对照组不使用HEXA机器人进行30分钟的训练。治疗方案为每周3次，共12次。在第1次治疗前和第12次治疗后，对两组患者的步行质量、残疾程度和生活质量进行评估。

结果

结果显示，时间的主效应在所有结局指标中均具有显著性（P<0.05），两组患者在干预后所有结局指标均有显著改善。组间主效应在6分钟步行试验（6MWT）（P<0.05）和定时起立行走试验（TUG）（P<0.05）的结局指标中也具有显著性，干预组患者在这两项测试中的行走距离更远、速度更快。本研究经马什哈德医科大学伦理委员会批准（日期为2022年1月28日的IR.MUMS.FHMPM.REC.1400.079）。该试验于2022年1月28日在www.IRCT.ir的临床试验网站注册（IRCT20210730052024N1）。