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改变康复环境以提高脑卒中幸存者的活动能力:一项 II 期试验。

Altering the rehabilitation environment to improve stroke survivor activity: A Phase II trial.

机构信息

5260Hunter New England Local Health District, Australia.

Hunter Medical Research Institute, Australia.

出版信息

Int J Stroke. 2022 Mar;17(3):299-307. doi: 10.1177/17474930211006999. Epub 2021 Apr 13.

Abstract

BACKGROUND

Environmental enrichment involves organization of the environment and provision of equipment to facilitate engagement in physical, cognitive, and social activities. In animals with stroke, it promotes brain plasticity and recovery.

AIMS

To assess the feasibility and safety of a patient-driven model of environmental enrichment incorporating access to communal and individual environmental enrichment.

METHODS

A nonrandomized cluster trial with blinded measurement involving people with stroke ( = 193) in four rehabilitation units was carried out. Feasibility was operationalized as activity 10 days after admission to rehabilitation and availability of environmental enrichment. Safety was measured as falls and serious adverse events. Benefit was measured as clinical outcomes at three months, by an assessor blinded to group.

RESULTS

The experimental group ( = 91) spent 7% (95% CI -14 to 0) less time inactive, 9% (95% CI 0-19) more time physically, and 6% (95% CI 2-10) more time socially active than the control group ( = 102). Communal environmental enrichment was available 100% of the time, but individual environmental enrichment was rarely within reach (24%) or sight (39%). There were no between-group differences in serious adverse events or falls at discharge or three months or in clinical outcomes at three months.

CONCLUSIONS

This patient-driven model of environmental enrichment was feasible and safe. However, the very modest increase in activity by people with stroke, and the lack of benefit in clinical outcomes three months after stroke do not provide justification for an efficacy trial.

摘要

背景

环境丰富涉及环境的组织和设备的提供,以促进身体、认知和社会活动的参与。在中风动物中,它促进大脑的可塑性和恢复。

目的

评估患者驱动的环境丰富模式的可行性和安全性,该模式包括获得公共和个人环境丰富。

方法

一项非随机集群试验,涉及四个康复病房的 193 名中风患者,采用盲法测量。可行性是通过入院后 10 天的活动和环境丰富的可用性来操作的。安全性是通过跌倒和严重不良事件来衡量的。三个月时的临床结果由对分组不知情的评估者进行测量,作为益处。

结果

实验组(n=91)比对照组(n=102) inactive 的时间少 7%(95%CI-14 到 0),physical 的时间多 9%(95%CI0-19),social 的时间多 6%(95%CI2-10)。公共环境丰富的可用性为 100%,但个人环境丰富很少在触及范围内(24%)或视线范围内(39%)。出院时、三个月时以及三个月时的临床结果在严重不良事件或跌倒方面无组间差异。

结论

这种患者驱动的环境丰富模式是可行和安全的。然而,中风患者的活动量增加非常有限,中风后三个月的临床结果没有获益,这不能证明进行疗效试验是合理的。

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