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重症监护病房获得性肌无力患者悬吊式下肢康复机器人辅助治疗的早期疗效观察:一项自身对照随机对照试验的研究方案

Early efficacy observation of suspended lower-limb rehabilitation robot-assisted therapy in patients with intensive care unit-acquired weakness: a study protocol for a self-controlled randomised controlled trial.

作者信息

Xu Lifan, Wu Heng, Huang Xiaonan, Song Jialiang, Fang Fanfu

机构信息

Department of Rehabilitation Medicine, Changhai Hospital, Shanghai, China.

Shanghai University of Sport School of Exercise and Health, Shanghai, China.

出版信息

BMJ Open. 2025 May 30;15(5):e093934. doi: 10.1136/bmjopen-2024-093934.

Abstract

INTRODUCTION

Intensive care unit-acquired weakness (ICUAW) is a common and severe complication in critically ill patients, associated with high morbidity and poor prognosis. Despite increasing focus on ICUAW, definitive diagnostic and therapeutic strategies remain absent. Early mobilisation has been demonstrated as an effective intervention for preventing and alleviating ICUAW. This study aims to evaluate the early-stage efficacy of suspended lower-limb rehabilitation robot-assisted therapy in patients with ICUAW.

METHODS AND ANALYSIS

This study is a self-controlled randomised trial aiming to include 60 patients with ICUAW. Each patient's lower limbs will be randomly assigned to either the experimental group or the control group. The control group will receive standard rehabilitation therapy, while the experimental group will receive additional suspended lower-limb rehabilitation robot-assisted therapy alongside standard care. The intervention will be delivered for 40 min daily, 5 days per week, over a 2-week period. The primary outcome measure is the thickness of key lower-limb muscles assessed via musculoskeletal ultrasound. Secondary outcome measures include the Medical Research Council score, range of motion of the lower-limb joints, and limb circumference. Data will be collected at baseline, after 1 week of intervention and at the 2-week endpoint.

ETHICS AND DISSEMINATION

This study has received ethical approval from the Research Ethics Committee of Changhai Hospital, affiliated with the Naval Medical University (approval reference: CHEC2023-055). Written informed consent will be obtained from all participants prior to their inclusion in the study. The findings, including both positive and negative outcomes, will be disseminated through publication in international peer-reviewed journals and presentation at relevant academic conferences.

TRIAL REGISTRATION NUMBER

ChiCTR2300070118.

摘要

引言

重症监护病房获得性肌无力(ICUAW)是危重症患者常见且严重的并发症,发病率高且预后不良。尽管对ICUAW的关注日益增加,但仍缺乏明确的诊断和治疗策略。早期活动已被证明是预防和减轻ICUAW的有效干预措施。本研究旨在评估悬吊式下肢康复机器人辅助治疗对ICUAW患者的早期疗效。

方法与分析

本研究为自身对照随机试验,旨在纳入60例ICUAW患者。每位患者的下肢将被随机分配至实验组或对照组。对照组将接受标准康复治疗,而实验组在接受标准护理的同时,还将接受额外的悬吊式下肢康复机器人辅助治疗。干预将每天进行40分钟,每周5天,为期2周。主要结局指标是通过肌肉骨骼超声评估的下肢关键肌肉厚度。次要结局指标包括医学研究委员会评分、下肢关节活动范围和肢体周长。数据将在基线、干预1周后和2周终点时收集。

伦理与传播

本研究已获得海军军医大学附属长海医院研究伦理委员会的伦理批准(批准文号:CHEC2023-055)。在所有参与者纳入研究之前,将获得他们的书面知情同意书。研究结果,包括阳性和阴性结果,将通过在国际同行评审期刊上发表以及在相关学术会议上报告进行传播。

试验注册号

ChiCTR2300070118。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e103/12128447/3274665879e2/bmjopen-15-5-g001.jpg

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