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棱镜适应对慢性右侧中风患者平衡和姿势障碍的影响:一项多中心、双盲、随机、 sham 对照试验方案。

Effects of prismatic adaptation on balance and postural disorders in patients with chronic right stroke: protocol for a multicentre double-blind randomised sham-controlled trial.

机构信息

Service de médecine physique et réadaptation, hôpital Henry Gabrielle, Hospices Civils de Lyon, Saint-Genis Laval, France

Equipe 'Trajectoires', Centre de Recherche en Neurosciences de Lyon, Inserm UMR-S 1028, CNRS UMR 5292, Université de Lyon, Université Lyon 1, Bron, France.

出版信息

BMJ Open. 2021 Nov 24;11(11):e052086. doi: 10.1136/bmjopen-2021-052086.

Abstract

INTRODUCTION

Patients with right stroke lesion have postural and balance disorders, including weight-bearing asymmetry, more pronounced than patients with left stroke lesion. Spatial cognition disorders post-stroke, such as misperceptions of subjective straight-ahead and subjective longitudinal body axis, are suspected to be involved in these postural and balance disorders. Prismatic adaptation has showed beneficial effects to reduce visuomotor disorders but also an expansion of effects on cognitive functions, including spatial cognition. Preliminary studies with a low level of evidence have suggested positive effects of prismatic adaptation on weight-bearing asymmetry and balance after stroke. The objective is to investigate the effects of this intervention on balance but also on postural disorders, subjective straight-ahead, longitudinal body axis and autonomy in patients with chronic right stroke lesion.

METHODS AND ANALYSIS

In this multicentre randomised double-blind sham-controlled trial, we will include 28 patients aged from 18 to 80 years, with a first right supratentorial stroke lesion at chronic stage (≥12 months) and having a bearing ≥60% of body weight on the right lower limb. Participants will be randomly assigned to the experimental group (performing pointing tasks while wearing glasses shifting optical axis of 10 degrees towards the right side) or to the control group (performing the same procedure while wearing neutral glasses without optical deviation). All participants will receive a 20 min daily session for 2 weeks in addition to conventional rehabilitation. The primary outcome will be the balance measured using the Berg Balance Scale. Secondary outcomes will include weight-bearing asymmetry and parameters of body sway during static posturographic assessments, as well as lateropulsion (measured using the Scale for Contraversive Pushing), subjective straight-ahead, longitudinal body axis and autonomy (measured using the Barthel Index).

ETHICS AND DISSEMINATION

The study has been approved by the ethical review board in France. Findings will be submitted to peer-reviewed journals relative to rehabilitation or stroke.

TRIAL REGISTRATION NUMBER

NCT03154138.

摘要

介绍

右侧中风患者存在姿势和平衡障碍,包括承重不对称,比左侧中风患者更为明显。中风后空间认知障碍,如主观直线和主观纵向身体轴的错觉,被怀疑与这些姿势和平衡障碍有关。棱镜适应已显示出对减少视动障碍有益的效果,但也对认知功能(包括空间认知)产生了扩展效应。初步的低证据研究表明,棱镜适应对中风后承重不对称和平衡有积极影响。本研究的目的是研究这种干预对慢性右侧中风患者平衡的影响,以及对姿势障碍、主观直线、纵向身体轴和自主性的影响。

方法与分析

在这项多中心随机双盲假对照试验中,我们将纳入 28 名年龄在 18 至 80 岁之间、首次右额顶叶中风且右下肢承重≥60%的慢性期(≥12 个月)患者。参与者将被随机分配到实验组(戴眼镜时进行指向任务,使光学轴向右偏移 10 度)或对照组(戴中性眼镜,无光学偏差)。所有参与者将在接受常规康复治疗的基础上,每天接受 20 分钟的治疗,持续 2 周。主要结果将是使用 Berg 平衡量表测量的平衡。次要结果将包括静态姿势描记评估中承重不对称和身体摆动参数,以及横向推力(使用对抗推力量表测量)、主观直线、纵向身体轴和自主性(使用巴氏量表测量)。

伦理与传播

该研究已获得法国伦理审查委员会的批准。研究结果将提交给与康复或中风相关的同行评议期刊。

试验注册号

NCT03154138。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0afc/8614142/bade385cfcb3/bmjopen-2021-052086f01.jpg

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