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虚拟现实步态训练与非虚拟现实步态训练对改善亚急性卒中幸存者参与度的比较:ViRTAS随机对照试验的研究方案

Virtual reality gait training versus non-virtual reality gait training for improving participation in subacute stroke survivors: study protocol of the ViRTAS randomized controlled trial.

作者信息

de Rooij Ilona J M, van de Port Ingrid G L, Visser-Meily Johanna M A, Meijer Jan-Willem G

机构信息

Revant Rehabilitation Centres, Breda, The Netherlands.

Center of Excellence for Rehabilitation Medicine, Brain Center Rudolf Magnus, University Medical Center Utrecht, and De Hoogstraat Rehabilitation, Utrecht, The Netherlands.

出版信息

Trials. 2019 Jan 29;20(1):89. doi: 10.1186/s13063-018-3165-7.

Abstract

BACKGROUND

A stroke often results in gait impairments, activity limitations and restricted participation in daily life. Virtual reality (VR) has shown to be beneficial for improving gait ability after stroke. Previous studies regarding VR focused mainly on improvements in functional outcomes. As participation in daily life is an important goal for rehabilitation after stroke, it is of importance to investigate if VR gait training improves participation. The primary aim of this study is to examine the effect of VR gait training on participation in community-living people after stroke.

METHODS/DESIGN: The ViRTAS study comprises a single-blinded, randomized controlled trial with two parallel groups. Fifty people between 2 weeks and 6 months after stroke, who experience constraints with walking in daily life, are randomly assigned to the virtual reality gait training (VRT) group or the non-virtual reality gait training (non-VRT) group. Both training interventions consist of 12 30-min sessions in an outpatient rehabilitation clinic during 6 weeks. Assessments are performed at baseline, post intervention and 3 months post intervention. The primary outcome is participation measured with the Utrecht Scale for Evaluation of Rehabilitation-Participation (USER-P). Secondary outcomes are subjective physical functioning, functional mobility, walking ability, walking activity, fatigue, anxiety and depression, falls efficacy and quality of life.

DISCUSSION

The results of the study provide insight into the effect of VR gait training on participation after stroke.

TRIAL REGISTRATION

Netherlands National Trial Register, Identifier NTR6215 . Registered on 3 February 2017.

摘要

背景

中风常导致步态障碍、活动受限及日常生活参与受限。虚拟现实(VR)已被证明对改善中风后的步态能力有益。以往关于VR的研究主要集中在功能结局的改善上。由于参与日常生活是中风后康复的一个重要目标,因此研究VR步态训练是否能改善参与度具有重要意义。本研究的主要目的是检验VR步态训练对中风后社区生活人群参与度的影响。

方法/设计:ViRTAS研究包括一项单盲、随机对照试验,分为两个平行组。50名在中风后2周和6个月之间、日常生活中行走有困难的人被随机分配到虚拟现实步态训练(VRT)组或非虚拟现实步态训练(非VRT)组。两种训练干预均在门诊康复诊所进行,为期6周,每周12次,每次30分钟。在基线、干预后和干预后3个月进行评估。主要结局是用乌得勒支康复参与评估量表(USER-P)测量的参与度。次要结局包括主观身体功能、功能移动性、行走能力、行走活动、疲劳、焦虑和抑郁、跌倒效能和生活质量。

讨论

该研究结果为了解VR步态训练对中风后参与度的影响提供了依据。

试验注册

荷兰国家试验注册库,标识符NTR6215。于2017年2月3日注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a8a1/6352452/b0e092f61a4a/13063_2018_3165_Fig1_HTML.jpg

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