Rossetto Federica, Mestanza Mattos Fabiola Giovanna, Gervasoni Elisa, Germanotta Marco, Pavan Arianna, Cattaneo Davide, Aprile Irene, Baglio Francesca
IRCCS Fondazione Don Carlo Gnocchi ONLUS, Milan-Florence, Italy.
Department of Pathophysiology and Transplantation, Università degli Studi di Milano, Milan, Italy.
Digit Health. 2024 Mar 7;10:20552076241228928. doi: 10.1177/20552076241228928. eCollection 2024 Jan-Dec.
Chronic Neurological Disorders (CNDs) are among the leading causes of disability worldwide, and their contribution to the overall need for rehabilitation is increasing. Therefore, the identification of new digital solutions to ensure early and continuous care is mandatory.
This protocol proposes to test the usability, acceptability, safety, and efficacy of Telerehabilitation (TR) protocols with digital and robotic tools in reducing the perceived level of disability in CNDs including Parkinson's Disease (PD), Multiple Sclerosis (MS), and post-stroke patients.
This single-blinded, multi-site, randomized, two-treatment arms controlled clinical trial will involve PD (N = 30), MS (N = 30), and post-stroke (N = 30). Each participant will be randomized (1:1) to the experimental group (20 sessions of motor telerehabilitation with digital and robotic tools) or the active control group (20 home-based motor rehabilitation sessions according to the usual care treatment). Primary and secondary outcome measures will be obtained at the baseline (T0), post-intervention (T1, 5 weeks after baseline), and at follow-up (T2, 2 months after treatment).
a multifaceted evaluation including quality of life, motor, and clinical/functional measures will be conducted at each time-point of assessment. The primary outcome measures will be the change in the perceived level of disability as measured by the World Health Organization Disability Assessment Schedule 2.0.
The implementation of TR protocols will enable a more targeted and effective response to the growing need for rehabilitation linked to CNDs, ensuring accessibility to rehabilitation services from the initial stages of the disease.
慢性神经疾病(CND)是全球致残的主要原因之一,其对康复总体需求的影响正在增加。因此,必须确定新的数字解决方案以确保早期和持续护理。
本方案提议测试远程康复(TR)方案结合数字和机器人工具在降低包括帕金森病(PD)、多发性硬化症(MS)和中风后患者在内的慢性神经疾病患者感知残疾水平方面的可用性、可接受性、安全性和有效性。
设计、设置和受试者:这项单盲、多中心、随机、双治疗组对照临床试验将纳入30例帕金森病患者、30例多发性硬化症患者和30例中风后患者。每位参与者将被随机(1:1)分配到实验组(使用数字和机器人工具进行20次运动远程康复)或积极对照组(根据常规护理治疗进行20次家庭运动康复)。在基线(T0)、干预后(T1,基线后5周)和随访时(T2,治疗后2个月)获取主要和次要结局指标。
在每个评估时间点进行多方面评估,包括生活质量、运动以及临床/功能指标。主要结局指标将是由世界卫生组织残疾评估量表2.0测量的感知残疾水平的变化。
实施远程康复方案将能够更有针对性和有效地应对与慢性神经疾病相关的康复需求增长,确保从疾病初始阶段即可获得康复服务。