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基于人工智能的脑卒中后患者上肢运动功能评估与康复训练系统研究:一项随机对照试验的研究方案

Research on the evaluation and rehabilitation training system of upper limb motor function for poststroke patients based on artificial intelligence: a study protocol for a randomized controlled trial.

作者信息

Xie Qiurong, Zhang Qi, Wang Xiaoling, Luo Jia, Sheng Bo

机构信息

College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, 350122, China.

Key Laboratory of Orthopedics & Traumatology of Traditional Chinese Medicine and Rehabilitation, Fujian University of Traditional Chinese Medicine, Ministry of Education, Fuzhou, 350122, China.

出版信息

Trials. 2025 Jun 13;26(1):204. doi: 10.1186/s13063-025-08914-7.

Abstract

BACKGROUND

Stroke-induced upper limb dysfunction requires functional assessment and rehabilitation. The intelligent rehabilitation assessment and virtual reality training system for upper limb motor function in stroke can accurately and objectively assess patients' motor function and guide their rehabilitation training. Our study aims to verify the clinical efficacy of the virtual reality training system in improving upper limb motor dysfunction in poststroke patients.

METHODS/DESIGN: This study will be a single-center, single-blind, randomized controlled clinical study. Fifty eligible patients will be randomized in a 1:1 ratio into a virtual reality training group (VR) and a conventional upper extremity treatment (CT) group. The intervention will be performed five times per week for 4 weeks. The primary outcome will be the Fugl-Meyer Motor Function Assessment-Upper Extremity (FMA-UE), and the secondary effects will be kinematic and electromyographic assessments. Adverse events will be recorded, and serious adverse events will be used as criteria for discontinuation of the intervention.

DISCUSSION

A stroke upper limb motor function assessment and virtual reality rehabilitation training system based on the FTHUE scale can achieve a close link between intelligent assessment and treatment of upper limb motor function in poststroke patients while integrating the design concepts of the upper limb and hand assessment and treatment, which can theoretically improve upper limb function in stroke to a greater extent, but further high-quality studies are needed. The results of this trial will determine whether an assessment and training system based on the FTHUE scale can improve upper extremity motor dysfunction after stroke.

TRIAL REGISTRATION

Chinese Clinical Trial Registration Center, ChiCTR2200060214. Registered May 22, 2022. Manuscript Version: 2.0 Manuscript Date: May 2, 2025.

摘要

背景

中风所致上肢功能障碍需要进行功能评估和康复治疗。中风上肢运动功能智能康复评估与虚拟现实训练系统能够准确、客观地评估患者的运动功能,并指导其康复训练。我们的研究旨在验证虚拟现实训练系统对改善中风后患者上肢运动功能障碍的临床疗效。

方法/设计:本研究将是一项单中心、单盲、随机对照临床研究。50名符合条件的患者将按1:1的比例随机分为虚拟现实训练组(VR)和传统上肢治疗组(CT)。干预将每周进行5次,共4周。主要结局将是Fugl-Meyer上肢运动功能评估(FMA-UE),次要效应将是运动学和肌电图评估。将记录不良事件,严重不良事件将作为停止干预的标准。

讨论

基于FTHUE量表的中风上肢运动功能评估和虚拟现实康复训练系统能够实现中风后患者上肢运动功能的智能评估与治疗之间的紧密联系,同时融合上肢和手部评估与治疗的设计理念,理论上可以在更大程度上改善中风患者的上肢功能,但仍需要进一步的高质量研究。本试验的结果将确定基于FTHUE量表的评估和训练系统是否能够改善中风后的上肢运动功能障碍。

试验注册

中国临床试验注册中心,ChiCTR2200060214。于2022年5月22日注册。稿件版本:2.0 稿件日期:2025年5月2日。

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