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基于微信的慢性前庭综合征患者前庭康复治疗:一项随机对照试验方案。

WeChat-based vestibular rehabilitation for patients with chronic vestibular syndrome: protocol for a randomised controlled trial.

机构信息

Nursing Department, Eye and ENT Hospital of Fudan University, Shanghai, China.

Fudan University School of Nursing, Shanghai, China.

出版信息

BMJ Open. 2021 Mar 2;11(3):e042637. doi: 10.1136/bmjopen-2020-042637.

Abstract

INTRODUCTION

Dizziness is one of the most common symptoms seen in chronic vestibular syndrome, which has been linked to an increased risk of falls, substantial disability and negative psychological consequences. Recent evidence demonstrated that vestibular rehabilitation therapy (VRT) is effective for treating chronic vestibular symptoms. However, the delivery of VRT remains challenging because of lack of facility, insufficient qualified physiotherapist resources, as well as being in the actual situation of the pandemic. WeChat, the most widely used mobile app in China, offers a more viable way of delivering VRT than traditional office-based approaches do. This study aimed to evaluate the effectiveness of the WeChat-VRT programme for patients with chronic vestibular syndrome.

METHODS AND ANALYSIS

This is a parallel-group, assessor-blinded randomised controlled trial. Fifty patients who experienced chronic vestibular symptoms longer than 3 months will be randomised into either the WeChat-VRT group or the usual care (UC) group. Participants in the WeChat-VRT group will receive 8-week VRT mainly through the WeChat app. Participants in the UC group will receive once-weekly VRT in the clinic for 8 weeks and remaining time home-based exercise. Outcome assessments will take place at baseline and at the 8th, 12th and 24th weeks after randomisation. The primary outcome will be the change from baseline to the eighth week on the patients' functional improvements quantified by the Functional Gait Assessment (FGA). The secondary outcomes will include dynamic balance function, emotional well-being, and vestibular activity and participation level. Intention-to-treat analysis will be performed using generalised estimation equation modelling.

ETHICS AND DISSEMINATION

The trial has been reviewed and approved by the Institutional Review Board of Eye and Ear Nose Throat Hospital of Fudan University (reference number 2017047/1). The study findings will be disseminated via peer-reviewed journals and conferences.

TRIAL REGISTRATION NUMBER

ChiCTR2000029457; Pre-results.

摘要

简介

头晕是慢性前庭综合征最常见的症状之一,与跌倒风险增加、严重残疾和负面心理后果相关。最近的证据表明,前庭康复治疗(VRT)对治疗慢性前庭症状有效。然而,由于缺乏设施、合格的物理治疗师资源不足,以及大流行的实际情况,VRT 的实施仍然具有挑战性。微信是中国使用最广泛的移动应用程序,为提供 VRT 提供了比传统基于办公室的方法更可行的方式。本研究旨在评估微信-VRT 方案对慢性前庭综合征患者的疗效。

方法和分析

这是一项平行组、评估者盲法随机对照试验。将 50 名患有慢性前庭症状超过 3 个月的患者随机分为微信-VRT 组或常规护理(UC)组。微信-VRT 组的参与者将主要通过微信应用程序接受 8 周的 VRT。UC 组的参与者将在诊所接受每周一次的 8 周 VRT,其余时间在家中进行锻炼。在基线和随机分组后的第 8、12 和 24 周进行结果评估。主要结局指标是患者功能改善的变化,采用功能性步态评估(FGA)从基线到第 8 周量化。次要结局指标包括动态平衡功能、情绪健康、前庭活动和参与水平。将使用广义估计方程模型进行意向治疗分析。

伦理和传播

该试验已由复旦大学眼耳鼻喉科医院机构审查委员会审查和批准(编号 2017047/1)。研究结果将通过同行评议的期刊和会议进行传播。

试验注册号

ChiCTR2000029457;预结果。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6ec9/7929820/4c77a65d9498/bmjopen-2020-042637f01.jpg

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