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视动刺激治疗慢性脑卒中后单侧空间忽略患者的效果:一项随机对照试验的研究方案。

Optokinetic stimulation effects in the management of unilateral spatial neglect in patients with chronic stroke: study protocol for a randomised controlled trial.

机构信息

Department of Nursing and Physiotherapy, University of Salamanca, Salamanca, Spain.

Department of Nursing and Physiotherapy, University of Salamanca, Salamanca, Spain

出版信息

BMJ Open. 2023 Jul 30;13(7):e070601. doi: 10.1136/bmjopen-2022-070601.

Abstract

INTRODUCTION

Unilateral spatial neglect (USN) is a stroke complication of stroke. Optokinetic stimulation (OKS) is one of the treatments, but its effects on motor symptoms, such as poverty or alterations in movements on the affected side, are not clear yet. The aim of this study will be to evaluate the OKS effects on the perceptual and postural complications of patients with USN.

METHODS AND ANALYSIS

Randomised double-blinded clinical trial, with an intervention group that will undergo OKS and a control placebo group. The research will take place at the Faculty of Nursing and Physiotherapy, University of Salamanca, 102 patients older than 18 years with diagnosed USN will participate. The intervention group will receive 2 weekly OKS session for 10 weeks. Virtual reality glasses will be used for the application of a video. The video will project OKS at a preset speed and will request the participant's attention throughout the session. The control group will receive a placebo treatment, through a virtual reality video. The measurement variables will be posturography, Fluff test, line bisection, Fullerton Advance Balance Scale and Diller's cancellation test.

ETHICS AND DISSEMINATION

This study has been approved by the Ethics Committee University of Salamanca on February 2020 (registration number: 584). All patients in the study will be informed about the objective of the study and will give their written informed consent to participate in the study. The anonymised database will be available from the publication of the results for 10 years in the repository of the University of Salamanca GREDOS (https://gredos.usal.es/). The trial results will be shared with the scientific community at international conferences and by publication in a peer-reviewed journal.

TRIAL REGISTRATION NUMBER

NCT04663646.

摘要

简介

单侧空间忽略(USN)是中风的一种并发症。视动刺激(OKS)是一种治疗方法,但它对运动症状(如患侧运动的贫困或改变)的影响尚不清楚。本研究的目的将是评估 OKS 对 USN 患者的知觉和姿势并发症的影响。

方法和分析

这是一项随机双盲临床试验,干预组将接受 OKS 治疗,对照组将接受安慰剂治疗。研究将在萨拉曼卡大学护理与理疗学院进行,将有 102 名年龄在 18 岁以上的被诊断为 USN 的患者参与。干预组将接受 2 周 10 次 OKS 治疗。将使用虚拟现实眼镜来应用视频。该视频将以预设速度投射 OKS,并要求参与者在整个治疗过程中集中注意力。对照组将接受虚拟现实视频的安慰剂治疗。测量变量将包括姿势描记术、Fluff 测试、线二分法、Fullerton 高级平衡量表和 Diller 取消测试。

伦理和传播

本研究已得到萨拉曼卡大学伦理委员会 2020 年 2 月的批准(注册号:584)。研究中的所有患者都将被告知研究的目的,并将书面同意参加研究。匿名数据库将在研究结果发布后 10 年在萨拉曼卡大学 GREDOS 的存储库(https://gredos.usal.es/)中提供。试验结果将在国际会议上与科学界分享,并在同行评议的期刊上发表。

试验注册号

NCT04663646。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e516/10391818/1c04a97cd09b/bmjopen-2022-070601f01.jpg

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