Tedesco Triccas Lisa, Sporn Sebastian, Coll I Omana Mireia, Brander Fran, Kelly Kate, Bestmann Sven, Ward Nick
Department of Clinical and Movement Neurosciences, UCL Queen Square Institute of Neurology, London, UK
Faculty of Rehabilitation Sciences, REVAL Rehabilitation Research Center, Hasselt University, Hasselt, Belgium.
BMJ Open. 2025 Feb 18;15(2):e095766. doi: 10.1136/bmjopen-2024-095766.
There is currently insufficient high-quality evidence to make general recommendations about high-dose high-intensity upper-limb rehabilitation programmes. Here we describe a randomised controlled trial that will determine the efficacy of two forms of high-dose, high-intensity upper-limb rehabilitation provided in a rehabilitation unit setting.
Patients with moderate upper-limb impairment (n=105, at least 6 months after stroke) will be randomised to either (1) high-dose high-intensity conventional upper-limb rehabilitation, (2) high-dose high-intensity virtual reality-based upper-limb rehabilitation and (3) usual care (a waiting list control group). Groups 1 and 2 will receive a minimum of 45 hours of active time on task over 3 weeks. Outcome measures will be collected at (T1) baseline; (T2) immediately post intervention and (T3) 3 months after the intervention has finished. The primary outcome measure will be the Fugl-Meyer Upper Extremity Assessment at 3 months after the intervention. Secondary outcome measures will be clinical, kinematic and neurophysiological using transcranial magnetic stimulation and electroencephalography. Explanatory measures will include MRI-based markers for integrity of the corticospinal tract, dorsal column-medial lemniscal pathway, grey and white matter and lesion load. The aim is to detect a difference of 7.25 points on the Fugl-Meyer Upper Extremity Assessment between each treatment group and the waitlist control group, with a power of 0.9 and significance of 0.025 (to account for two primary analyses). Analysis of change in the primary and secondary outcome measures will be performed using mulitple regression analysis.
The study protocol (V.1) has been approved by the Wales Research Ethics Committee 2 Cardiff (Rec reference: 22/WA/0065) on 15 March 2022. All recruited participants will provide informed consent. Trial results will be disseminated through peer-reviewed publications, presentations at major stroke/neurorehabilitation conferences and outreach to relevant stakeholder communities.
NCT05527262.
目前，尚无足够的高质量证据来对高剂量高强度上肢康复计划提出一般性建议。在此，我们描述一项随机对照试验，该试验将确定在康复单元环境中提供的两种高剂量、高强度上肢康复形式的疗效。
中度上肢功能障碍患者（n = 105，中风后至少6个月）将被随机分为三组：（1）高剂量高强度传统上肢康复组；（2）高剂量高强度虚拟现实上肢康复组；（3）常规护理组（等待名单对照组）。第1组和第2组将在3周内接受至少45小时的实际任务活动时间。将在以下时间点收集结果指标：（T1）基线；（T2）干预结束后立即；（T3）干预结束后3个月。主要结果指标将是干预后3个月时的Fugl-Meyer上肢评估。次要结果指标将包括使用经颅磁刺激和脑电图的临床、运动学和神经生理学指标。解释性指标将包括基于MRI的皮质脊髓束、背柱-内侧丘系通路、灰质和白质完整性以及病变负荷的标志物。目的是检测每个治疗组与等待名单对照组在Fugl-Meyer上肢评估上相差7.25分，检验效能为0.9，显著性水平为0.025（考虑两次主要分析）。将使用多元回归分析对主要和次要结果指标的变化进行分析。
该研究方案（V.1）于2022年3月15日获得威尔士研究伦理委员会2卡迪夫（伦理审查参考号：22/WA/0065）批准。所有招募的参与者都将提供知情同意书。试验结果将通过同行评审出版物、在主要中风/神经康复会议上的报告以及向相关利益相关者群体进行推广等方式进行传播。
NCT05527262。
