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增强现实式主动视频游戏对单阶段多次手术治疗脑瘫儿童步态训练效果的随机对照试验研究方案

Effect of an augmented reality active video game for gait training in children with cerebral palsy following single-event multilevel surgery: protocol for a randomised controlled trial.

机构信息

Pôle Recherche & Innovation, Fondation Ellen Poidatz, Saint Fargeau Ponthierry, France

IBISC Laboratory, Universite Paris-Saclay, Paris, France.

出版信息

BMJ Open. 2022 Oct 10;12(10):e061580. doi: 10.1136/bmjopen-2022-061580.

Abstract

INTRODUCTION

In paediatric rehabilitation, fun and motivation are also critical keys to successful therapy. A variety of interventions have shown positive effects, high level of interest, compliance and engagement with active video game (AVG).This seems to be an interesting approach for the postoperative gait rehabilitation of children with cerebral palsy (CP). In this study, we will investigate if an overground gait training (GT) delivered through an AVG can improve walking capacity and anaerobic performance.

METHODS AND ANALYSIS

This study is a randomised clinical controlled trial. A total of 14 children and adolescents in the age of 10-18 years with CP will be included. The minimum time between surgery and inclusion will be 7 weeks. The test group will participate in the GT programme with Augmented Reality Rehabilitation of Walking-Cerebral Palsy AVG, control group will receive GT on a treadmill. The primary outcome is the 6-Min Walk Test assessing walking capacity; secondary outcomes are the Muscle Power Sprint Test for anaerobic performance and Shuttle Run Test for physical fitness level. Satisfaction is tested with the Physical Activity Enjoyment Scale.

ETHICS AND DISSEMINATION

The findings will be disseminated by publications in peer-reviewed journals and conferences. This study received agreement from French ethic committee (Comité de Protection des Personnes Sud-Est VI-Number 2020-A02959-30).

TRIAL REGISTRATION NUMBER

NCT04837105.

摘要

简介

在儿科康复中,乐趣和动力也是成功治疗的关键。各种干预措施已显示出积极的效果,对积极视频游戏(AVG)的兴趣水平高、依从性好、参与度高。这对于脑瘫(CP)儿童的术后步态康复似乎是一种有趣的方法。在这项研究中,我们将研究通过 AVG 进行的地面步行训练(GT)是否可以提高步行能力和无氧表现。

方法和分析

这是一项随机对照临床试验。共有 14 名年龄在 10-18 岁的 CP 儿童和青少年将被纳入研究。手术和纳入之间的最短时间将为 7 周。实验组将参加增强现实康复步行-脑瘫 AVG 的 GT 计划,对照组将在跑步机上进行 GT。主要结果是 6 分钟步行测试评估步行能力;次要结果是肌肉力量短跑测试评估无氧表现和穿梭跑测试评估体能水平。满意度通过身体活动享受量表进行测试。

伦理和传播

研究结果将通过在同行评审期刊和会议上发表的文章进行传播。这项研究已获得法国伦理委员会(南东部六区保护委员会-编号 2020-A02959-30)的同意。

试验注册号

NCT04837105。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9cf8/9558782/d63db5c4310e/bmjopen-2022-061580f01.jpg

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