A Randomized Control Trial of a Virtually Delivered Program for Increasing Upper Limb Activity After Stroke.

Lisa A Simpson, Ruth Barclay, Mark T Bayley, Penelope M A Brasher, Sean P Dukelow, Bradley J MacIntosh, Marilyn MacKay-Lyons, Carlo Menon, W Ben Mortenson, Tzu-Hsuan Peng, Courtney L Pollock, Sepideh Pooyania, Noah D Silverberg, Robert Teasell, Jennifer Yao, Janice J Eng
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Abstract

Background: Upper limb activity following stroke is low, which may limit recovery. We investigated whether a virtually-delivered upper limb program, that included a wearable device with reach-to-grasp feedback, would increase upper limb activity after stroke.

Methods: This was a parallel-group, assessor-blinded, randomized control trial conducted at 6 sites across 5 provinces of the CanStroke Recovery Trials Platform between 2020 to 2022. Participants (n = 73) were community-living, less than 1 year post stroke, and had residual arm movement and upper limb use limitations. Participants were randomized via a central web-based randomization service to receive a virtually delivered program (Virtual Arm Boot Camp [V-ABC], n = 36) or waitlist control (n = 37) receiving usual care. V-ABC consisted of a home exercise program, feedback from a wrist-worn device to monitor reach-to-grasp counts, and 6 virtual sessions with a trained therapist over 3 weeks. The primary outcome was the average daily reach-to-grasp counts over 3 days at 4 weeks post baseline assessment. Secondary outcomes included upper limb function, self-reported use, and quality of life. Within-subject changes between pre, post treatment, and 2 months follow up for all participants were also examined as a tertiary analysis.

Results: The V-ABC group demonstrated greater average daily reach-to-grasp counts (primary outcome) at 4 weeks compared to control (mean difference = 368, 95% confidence interval = 6-730, P = .046).

Conclusions: This study provided evidence that a virtually delivered upper limb program that consists of exercise, feedback from a wearable device, and therapist support can increase real-world upper limb activity following stroke.

Clinical trial registration: NCT04232163.

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一项增加中风后上肢活动的虚拟交付方案的随机对照试验。
背景:中风后上肢活动较低,这可能限制康复。我们调查了一个虚拟的上肢项目,其中包括一个可穿戴设备,该设备具有伸手抓握反馈,是否会增加中风后上肢的活动。方法:这是一项平行组、评估盲、随机对照试验,于2020年至2022年在CanStroke康复试验平台的5个省的6个地点进行。参与者(n = 73)生活在社区,中风后不到1年,有残余手臂运动和上肢使用限制。参与者通过基于网络的中央随机化服务随机化,接受虚拟交付的程序(虚拟手臂新兵训练营[V-ABC], n = 36)或接受常规护理的候补名单控制(n = 37)。V-ABC包括一个家庭锻炼项目,来自腕带设备的反馈,以监测手握次数,以及与训练有素的治疗师在三周内进行的6次虚拟会话。主要结果是基线评估后4周3天的平均每日触手可及计数。次要结局包括上肢功能、自我报告的使用情况和生活质量。所有参与者治疗前、治疗后和2个月随访期间的受试者内部变化也作为三级分析进行检查。结果:与对照组相比,V-ABC组在4周时显示出更高的平均每日伸手到抓握计数(主要结局)(平均差异= 368,95%可信区间= 6-730,P = 0.046)。结论:这项研究提供了证据,表明由锻炼、可穿戴设备反馈和治疗师支持组成的虚拟上肢项目可以增加中风后真实上肢的活动。临床试验注册:NCT04232163。
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