Brain Sciences, Imperial College London, London, UK
Life Sciences, University of Southampton, Southampton, UK.
BMJ Open. 2024 Jan 19;14(1):e077121. doi: 10.1136/bmjopen-2023-077121.
Technology-facilitated, self-directed upper limb (UL) rehabilitation, as an adjunct to conventional care, could enhance poststroke UL recovery compared with conventional care alone, without imposing additional resource burden. The proposed pilot randomised controlled trial (RCT) aims to assess whether stroke survivors will engage in self-directed UL training, explore factors associated with intervention adherence and evaluate the study design for an RCT testing the efficacy of a self-directed exer-gaming intervention for UL recovery after stroke.
This is a multicentre, internal pilot RCT; parallel design, with nested qualitative methods. The sample will consist of stroke survivors with UL paresis, presenting within the previous 30 days. Participants randomised to the intervention group will be trained to use an exergaming device and will be supported to adopt this as part of their self-directed rehabilitation (ie, without formal support/supervision) for a 3-month period. The primary outcome will be the Fugl Meyer Upper Extremity Assessment (FM-UE) at 6 months poststroke. Secondary outcomes are the Action Research Arm Test (ARAT), the Barthel Index and the Modified Rankin Scale. Assessment time points will be prior to randomisation (0-1 month poststroke), 3 months and 6 months poststroke. A power calculation to inform sample size required for a definitive RCT will be conducted using FM-UE data from the sample across 0-6 months time points. Semistructured qualitative interviews will examine factors associated with intervention adoption. Reflexive thematic analysis will be used to code qualitative interview data and generate key themes associated with intervention adoption.
The study protocol (V.1.9) was granted ethical approval by the Health Research Authority, Health and Care Research Wales, and the London- Harrow Research Ethics Committee (ref. 21/LO/0054) on 19 May 2021. Trial results will be submitted for publication in peer-reviewed journals, presented at national and international stroke meetings and conferences and disseminated among stakeholder communities.
NCT04475692.
与传统护理相比，作为传统护理的辅助手段，借助技术的自我导向上肢（UL）康复可以增强中风后 UL 的恢复，而不会增加额外的资源负担。本研究拟进行一项随机对照试验（RCT），旨在评估中风幸存者是否会接受自我导向 UL 训练，探索与干预依从性相关的因素，并评估 RCT 测试中风后 UL 恢复的自我导向运动游戏干预疗效的研究设计。
这是一项多中心内部先导 RCT，采用平行设计，嵌入定性方法。样本将包括中风后出现 UL 瘫痪的患者，发病时间在 30 天内。随机分配到干预组的参与者将接受使用运动游戏设备的培训，并将在 3 个月内支持他们将其作为自我导向康复的一部分（即没有正式的支持/监督）。主要结果将是中风后 6 个月的 Fugl Meyer 上肢评估（FM-UE）。次要结果是动作研究上肢测试（ARAT）、巴氏指数和改良 Rankin 量表。评估时间点将在随机分组前（中风后 0-1 个月）、3 个月和 6 个月。使用 0-6 个月时间点的样本中 FM-UE 数据，进行功效计算以告知确定 RCT 所需的样本量。半结构定性访谈将探讨与干预采用相关的因素。反思性主题分析将用于对定性访谈数据进行编码，并生成与干预采用相关的关键主题。
该研究方案（V.1.9）于 2021 年 5 月 19 日获得了英国健康研究管理局、威尔士健康和护理研究管理局以及伦敦-哈罗研究伦理委员会的伦理批准（ref. 21/LO/0054）。试验结果将提交给同行评议期刊发表，在国家和国际中风会议上展示，并在利益相关者社区中传播。
NCT04475692。
