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“FIND技术”:探究无控制器交互式数字康复技术在住院脑卒中患者中的可行性、有效性和安全性:一项随机对照试验的研究方案

"FIND Technology": investigating the feasibility, efficacy and safety of controller-free interactive digital rehabilitation technology in an inpatient stroke population: study protocol for a randomized controlled trial.

作者信息

Bird M L, Cannell J, Callisaya M L, Moles E, Rathjen A, Lane K, Tyson A, Smith S

机构信息

Faculty of Health, University of Tasmania, Locked Bag 1322, Launceston, 7250, Australia.

Tasmanian Health Organisation, Launceston, Australia.

出版信息

Trials. 2016 Apr 16;17(1):203. doi: 10.1186/s13063-016-1318-0.

Abstract

BACKGROUND

Stroke results in significant disability, which can be reduced by physical rehabilitation. High levels of repetition and activity are required in rehabilitation, but patients are typically sedentary. Using clinically relevant and fun computer games may be one way to achieve increased activity in rehabilitation.

METHODS/DESIGN: A single-blind randomized controlled trial will be conducted to evaluate the feasibility, efficacy and safety of novel stroke-specific rehabilitation software. This software uses controller-free client interaction and inertial motion sensors. Elements of feasibility include recruitment into the trial, ongoing participation (adherence and dropout), perceived benefit, enjoyment and ease of use of the games. Efficacy will be determined by measuring activity and using upper-limb tasks as well as measures of balance and mobility. The hypothesis that the intervention group will have increased levels of physical activity within rehabilitation and improved physical outcomes compared with the control group will be tested.

DISCUSSION

Results from this study will provide a basis for discussion of feasibility of this interactive video technological solution in an inpatient situation. Differences in activity levels between groups will be the primary measure of efficacy. It will also provide data on measures of upper-limb function, balance and mobility.

TRIAL REGISTRATION

ACTRN12614000427673 . Prospectively registered 17 April 2014.

摘要

背景

中风会导致严重残疾,而通过物理康复可以减轻这种残疾。康复过程需要大量的重复练习和活动,但患者通常久坐不动。使用具有临床相关性且有趣的电脑游戏可能是增加康复活动量的一种方法。

方法/设计:将进行一项单盲随机对照试验,以评估新型中风特异性康复软件的可行性、有效性和安全性。该软件采用无控制器的客户端交互和惯性运动传感器。可行性要素包括纳入试验、持续参与(依从性和退出情况)、感知益处、游戏的趣味性和易用性。有效性将通过测量活动量、使用上肢任务以及平衡和移动性测量来确定。将检验干预组在康复过程中的身体活动水平高于对照组且身体状况得到改善这一假设。

讨论

本研究结果将为讨论这种交互式视频技术解决方案在住院环境中的可行性提供依据。两组之间活动水平的差异将是有效性的主要衡量标准。它还将提供有关上肢功能、平衡和移动性测量的数据。

试验注册

ACTRN12614000427673。于2014年4月17日前瞻性注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6fd9/4833958/f6fda19cd1f4/13063_2016_1318_Fig1_HTML.jpg

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