Hernández-Martínez Alba, Fernandez-Escabias Manuel, Amaya-Pascasio Laura, Carrilho-Candeias Sofia, Ramos-Teodoro Máriam, Gil-Rodríguez Mercedes, Orellana-Jaen Andrea, Martínez-Rosales Elena, Ruiz-González David, Esteban-Simón Alba, Castro-Ropero Belén, Del-Olmo-Iruela Laura, López-López María Isabel, Ramos-Herrera Ana Isabel, Fajardo-Rodríguez Manuel F, Gómez-García Silvia, Rodríguez-Camacho Marta, Conde-Negri Elena, Rodríguez-Pérez Mónica, Marcos-Pardo Pablo Jorge, Ruiz Jonatan R, Villegas-Rodríguez Inmaculada, Amaro-Gahete Francisco J, Martínez-Sánchez Patricia, Soriano-Maldonado Alberto
SPORT Research Group (CTS-1024), CIBIS (Centro de Investigación para el Bienestar y la Inclusión Social), University of Almería, Almería, Spain.
Department of Education, Faculty of Education Sciences, University of Almería, Almería, Spain.
BMJ Open Sport Exerc Med. 2024 Aug 7;10(3):e002123. doi: 10.1136/bmjsem-2024-002123. eCollection 2024.
Stroke is the leading cause of disability and the second cause of death worldwide. The increasing burden of stroke underscores the importance of optimising rehabilitation protocols. Virtual reality (VR) can improve poststroke prognosis. A VR software combining gamification, full immersion and stroke specificity (ie, the Development and validation of a novel viRtual rEality software for improving diSability and quality of lifE in patients with sTroke (RESET) software) might substantially improve disability and quality of life (QoL). However, this technology is still very scarce. The RESET trial aims to assess the effects of an early 10-week gamified, fully immersive and stroke-specific VR intervention (ie, starting at week 3 poststroke) on disability and QoL in people with stroke in the subacute phase. People with ischaemic or haemorrhagic stroke (n=94) aged 18 years will be randomised to receive (1) usual care (UC), (2) commercial VR or (3) gamified, fully immersive and stroke-specific VR (). The three groups will receive UC (ie, three sessions/week of 90 min of standard rehabilitation). The VR groups will additionally receive three VR sessions of 20 min per week. The outcome measures will be assessed at baseline (week 2 from stroke occurrence), week 13 (approximately 90 days from the event) and week 26 (approximately 6 months from the event). The primary outcome is disability measured with the Barthel Index. Secondary outcomes include QoL, upper-extremity and lower-extremity motor function, gross manual dexterity, handgrip strength and cognitive function. This study will unravel the effects of a gamified, fully immersive and stroke-specific VR software on disability and QoL in patients with stroke in the early subacute phase.Trial registration number: NCT06132399.
中风是全球致残的主要原因和第二大致死原因。中风负担的不断增加凸显了优化康复方案的重要性。虚拟现实（VR）可改善中风后的预后。一款结合了游戏化、完全沉浸式体验和中风特异性的VR软件（即用于改善中风患者残疾状况和生活质量的新型虚拟现实软件的开发与验证（RESET）软件）可能会显著改善残疾状况和生活质量（QoL）。然而，这项技术仍然非常稀缺。RESET试验旨在评估早期为期10周的游戏化、完全沉浸式且针对中风的VR干预（即从中风后第3周开始）对亚急性期中风患者残疾状况和生活质量的影响。年龄在18岁及以上的缺血性或出血性中风患者（n = 94）将被随机分组，以接受（1）常规护理（UC）、（2）商业VR或（3）游戏化、完全沉浸式且针对中风的VR（）。三组都将接受常规护理（即每周三次，每次90分钟的标准康复治疗）。VR组还将额外每周接受三次20分钟的VR治疗。结局指标将在基线（中风发生后第2周）、第13周（事件发生后约90天）和第26周（事件发生后约6个月）进行评估。主要结局是用巴氏指数测量的残疾状况。次要结局包括生活质量、上肢和下肢运动功能、手部总体灵巧性、握力和认知功能。本研究将揭示一款游戏化、完全沉浸式且针对中风的VR软件对亚急性期早期中风患者残疾状况和生活质量的影响。试验注册号：NCT06132399。
