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虚拟手臂训练营 (V-ABC):一项混合方法研究的研究方案,旨在通过强化计划和抓握计数设备来增加中风后的上肢康复。

Virtual Arm Boot Camp (V-ABC): study protocol for a mixed-methods study to increase upper limb recovery after stroke with an intensive program coupled with a grasp count device.

机构信息

Graduate Program in Rehabilitation Sciences, Faculty of Medicine, University of British Columbia, Vancouver, Canada.

Rehabilitation Research Program, GF Strong Rehabilitation Centre, Vancouver Coastal Health, Vancouver, Canada.

出版信息

Trials. 2022 Feb 8;23(1):129. doi: 10.1186/s13063-022-06047-9.

Abstract

BACKGROUND

Encouraging upper limb use and increasing intensity of practice in rehabilitation are two important goals for optimizing upper limb recovery post stroke. Feedback from novel wearable sensors may influence practice behaviour to promote achieving these goals. A wearable sensor can potentially be used in conjunction with a virtually monitored home program for greater patient convenience, or due to restrictions that preclude in-person visits, such as COVID-19. This trial aims to (1) determine the efficacy of a virtual behaviour change program that relies on feedback from a custom wearable sensor to increase use and function of the upper limb post stroke; and (2) explore the experiences and perceptions of using a program coupled with wearable sensors to increase arm use from the perspective of people with stroke.

METHODS

This mixed-methods study will utilize a prospective controlled trial with random allocation to immediate or 3-week delayed entry to determine the efficacy of a 3-week behaviour change program with a nested qualitative description study. The intervention, the Virtual Arm Boot Camp (V-ABC) features feedback from a wearable device, which is intended to increase upper limb use post stroke, as well as 6 virtual sessions with a therapist. Sixty-four adults within 1-year post stroke onset will be recruited from seven rehabilitation centres. All outcomes will be collected virtually. The primary outcome measure is upper limb use measured by grasp counts over 3 days from the wearable sensor (TENZR) after the 3-week intervention. Secondary outcomes include upper limb function (Arm Capacity and Movement Test) and self-reported function (Hand Function and Strength subscale from the Stroke Impact Scale). Outcome data will be collected at baseline, post-intervention and at 2 months retention. The qualitative component will explore the experiences and acceptability of using a home program with a wearable sensor for increasing arm use from the point of view of individuals with stroke. Semi-structured interviews will be conducted with participants after they have experienced the intervention. Qualitative data will be analysed using content analysis.

DISCUSSION

This study will provide novel information regarding the efficacy and acceptability of virtually delivered programs to improve upper extremity recovery, and the use of wearable sensors to assist with behaviour change.

TRIAL REGISTRATION

ClinicalTrials.gov NCT04232163 . January 18, 2020.

摘要

背景

鼓励上肢使用和增加康复练习的强度是优化脑卒中后上肢恢复的两个重要目标。新型可穿戴传感器的反馈可能会影响练习行为,以促进实现这些目标。可穿戴传感器可与虚拟监测家庭计划结合使用,以提高患者的便利性,或由于存在妨碍当面就诊的限制因素,如 COVID-19。本试验旨在:(1) 确定一种依赖于定制可穿戴传感器反馈来增加脑卒中后上肢使用和功能的虚拟行为改变计划的疗效;(2) 从脑卒中患者的角度探索使用增加手臂使用的方案和可穿戴传感器的体验和看法。

方法

本混合方法研究将采用前瞻性对照试验,随机分配立即或 3 周延迟进入,以确定 3 周行为改变计划的疗效,该计划具有嵌套定性描述研究。干预措施,即虚拟手臂训练营(V-ABC)具有来自可穿戴设备的反馈,旨在增加脑卒中后的上肢使用,以及与治疗师的 6 次虚拟会议。将从 7 个康复中心招募 64 名发病后 1 年内的成年人。所有结果都将通过虚拟方式收集。主要结局指标是 3 周干预后可穿戴传感器(TENZR)记录的 3 天内抓握次数测量的上肢使用情况。次要结局指标包括上肢功能(手臂容量和运动测试)和自我报告的功能(脑卒中影响量表的手功能和力量子量表)。在基线、干预后和 2 个月保留时收集结果数据。定性部分将从脑卒中患者的角度探讨使用带有可穿戴传感器的家庭计划增加手臂使用的体验和可接受性。在参与者体验完干预措施后,将对其进行半结构化访谈。使用内容分析法对定性数据进行分析。

讨论

本研究将提供有关虚拟交付方案改善上肢恢复的疗效和可接受性以及使用可穿戴传感器协助行为改变的新信息。

试验注册

ClinicalTrials.gov NCT04232163. 2020 年 1 月 18 日。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0a11/8822776/2bd6bd0ecef4/13063_2022_6047_Fig1_HTML.jpg

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