Francesca Baglio, Federica Rossetto, Elisa Gervasoni, Ilaria Carpinella, Giulia Smecca, Irene Aprile, Roberto De Icco, Stefania De Trane, Chiara Pavese, Christian Lunetta, Cira Fundarò, Laura Marcuccio, Giovanna Zamboni, Franco Molteni, Cristina Messa, Fit TeleNEURO Working Group
{"title":"Timely and Personalized Interventions and Vigilant Care in Neurodegenerative Conditions: The FIT4TeleNEURO Pragmatic Trial.","authors":"Francesca Baglio, Federica Rossetto, Elisa Gervasoni, Ilaria Carpinella, Giulia Smecca, Irene Aprile, Roberto De Icco, Stefania De Trane, Chiara Pavese, Christian Lunetta, Cira Fundarò, Laura Marcuccio, Giovanna Zamboni, Franco Molteni, Cristina Messa, Fit TeleNEURO Working Group","doi":"10.3390/healthcare13060682","DOIUrl":null,"url":null,"abstract":"<p><p>Parkinson's disease (PD) and multiple sclerosis (MS) are two chronic neurological diseases (CNDs) that have a high demand for early and continuous rehabilitation. However, accessing professional care remains a challenge, making it a key priority to identify sustainable solutions for ensuring early rehabilitation availability. <b>Objective</b>: The FIT4TeleNEURO pragmatic trial proposes to investigate, in real-life care settings, the superiority in terms of the effectiveness of early rehabilitation intervention with harmonized, mix-model telerehabilitation (TR) protocols (TR single approach, task-oriented-TRsA; TR combined approach, task-oriented and impairment-oriented-TRcA) compared to conventional management (control treatment, CeT) in people with PD and MS. <b>Design, and Methods</b>: This multicenter, randomized, three-treatment arm pragmatic trial will involve 300 patients with CNDs (PD, N = 150; MS, N = 150). Each participant will be randomized (1:1:1) to the experimental groups (20 sessions of TRsA or TRcA according to a mix-model-3 asynchronous + 1 synchronous session/week) or the control group (20 sessions of CeT). Primary and secondary outcome measures will be obtained at the baseline (T0), post-intervention (T1, 5 weeks after baseline), and follow-up (T2, 3 months after the end of the treatment). A multidimensional evaluation (cognitive, motor, and quality of life domains) will be conducted at each time point of assessment (T0; T1; T2). The primary outcome measures will be the assessment of change (T0 vs. T1 vs. T2) in static and dynamic balance, measured using the Mini-Balance Evaluation Systems Test. Usability and acceptability assessment will be also investigated. <b>Expected Results</b>: Implementing TR protocols will enable a more targeted and efficient response to the growing demand for rehabilitation in the early stages of CNDs. Both the TRsA and TRcA approaches are expected to be more effective than CeT, with the combined approach likely providing greater benefits in secondary outcome measures. Finally, the acceptability of the asynchronous modality could open the door to scalable solutions, such as digital therapeutics.</p>","PeriodicalId":12977,"journal":{"name":"Healthcare","volume":"13 6","pages":""},"PeriodicalIF":2.4000,"publicationDate":"2025-03-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11942313/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Healthcare","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.3390/healthcare13060682","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"HEALTH CARE SCIENCES & SERVICES","Score":null,"Total":0}
引用次数: 0
Abstract
Parkinson's disease (PD) and multiple sclerosis (MS) are two chronic neurological diseases (CNDs) that have a high demand for early and continuous rehabilitation. However, accessing professional care remains a challenge, making it a key priority to identify sustainable solutions for ensuring early rehabilitation availability. Objective: The FIT4TeleNEURO pragmatic trial proposes to investigate, in real-life care settings, the superiority in terms of the effectiveness of early rehabilitation intervention with harmonized, mix-model telerehabilitation (TR) protocols (TR single approach, task-oriented-TRsA; TR combined approach, task-oriented and impairment-oriented-TRcA) compared to conventional management (control treatment, CeT) in people with PD and MS. Design, and Methods: This multicenter, randomized, three-treatment arm pragmatic trial will involve 300 patients with CNDs (PD, N = 150; MS, N = 150). Each participant will be randomized (1:1:1) to the experimental groups (20 sessions of TRsA or TRcA according to a mix-model-3 asynchronous + 1 synchronous session/week) or the control group (20 sessions of CeT). Primary and secondary outcome measures will be obtained at the baseline (T0), post-intervention (T1, 5 weeks after baseline), and follow-up (T2, 3 months after the end of the treatment). A multidimensional evaluation (cognitive, motor, and quality of life domains) will be conducted at each time point of assessment (T0; T1; T2). The primary outcome measures will be the assessment of change (T0 vs. T1 vs. T2) in static and dynamic balance, measured using the Mini-Balance Evaluation Systems Test. Usability and acceptability assessment will be also investigated. Expected Results: Implementing TR protocols will enable a more targeted and efficient response to the growing demand for rehabilitation in the early stages of CNDs. Both the TRsA and TRcA approaches are expected to be more effective than CeT, with the combined approach likely providing greater benefits in secondary outcome measures. Finally, the acceptability of the asynchronous modality could open the door to scalable solutions, such as digital therapeutics.
帕金森病(PD)和多发性硬化症(MS)是两种对早期和持续康复有很高要求的慢性神经系统疾病(CNDs)。然而,获得专业护理仍然是一个挑战,因此确定可持续的解决方案以确保早期康复是一个关键的优先事项。目的:FIT4TeleNEURO实用试验旨在探讨在现实护理环境中,采用统一的混合模式远程康复(TR)方案(TR单一方法,任务导向- trsa;设计和方法:这项多中心、随机、三治疗组的实用试验将纳入300名CNDs患者(PD, N = 150;Ms, n = 150)。每个参与者将被随机(1:1:1)分配到实验组(按混合模式-3异步+ 1同步/周进行20次TRsA或TRcA)或对照组(20次CeT)。主要和次要结局指标将在基线(T0)、干预后(T1,基线后5周)和随访(T2,治疗结束后3个月)获得。在每个评估时间点进行多维度评估(认知、运动和生活质量领域)(T0;T1;T2)。主要结果测量将是评估静态和动态平衡的变化(T0 vs. T1 vs. T2),使用Mini-Balance评估系统测试进行测量。可用性和可接受性评估也将被调查。预期结果:实施TR协议将能够更有针对性和更有效地应对疾病早期阶段日益增长的康复需求。TRsA和TRcA方法预计都比CeT更有效,联合方法可能在次要结果测量中提供更大的益处。最后,异步模式的可接受性可以为可扩展的解决方案(如数字治疗)打开大门。
期刊介绍:
Healthcare (ISSN 2227-9032) is an international, peer-reviewed, open access journal (free for readers), which publishes original theoretical and empirical work in the interdisciplinary area of all aspects of medicine and health care research. Healthcare publishes Original Research Articles, Reviews, Case Reports, Research Notes and Short Communications. We encourage researchers to publish their experimental and theoretical results in as much detail as possible. For theoretical papers, full details of proofs must be provided so that the results can be checked; for experimental papers, full experimental details must be provided so that the results can be reproduced. Additionally, electronic files or software regarding the full details of the calculations, experimental procedure, etc., can be deposited along with the publication as “Supplementary Material”.