Bove Francesco, Di Lazzaro Giulia, Petracca Martina, Lo Monaco Maria Rita, Ricciardi Diego, Di Caro Francesca, Fragapane Serena, Giovannini Silvia, Iacovelli Chiara, Castelli Letizia, Bianco Assunta, Scala Irene, Broccolini Aldobrando, Caliandro Pietro, Le Pera Domenica, Furno Carmen, Arcuri Giovanni, Fares Guerino Massimo Oscar, Spandonaro Federico, Polistena Barbara, Calabresi Paolo, Bentivoglio Anna Rita
Neurology Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
Department of Neuroscience, Università Cattolica del Sacro Cuore, Largo Francesco Vito 1, Roma, 00168, Italia.
Neurol Sci. 2025 Jul 18. doi: 10.1007/s10072-025-08367-5.
An Early Feasibility Study (EFS) is an exploratory clinical investigation of a device to optimize its design through iterative feedback loops during early clinical experience. The ARCTRAN study is an EFS aimed at analyzing efficacy, safety and adherence to the home-rehabilitation device-based (ARC Intellicare) program compared to a paper-based exercise protocol in patients with Parkinson's disease (PD), Multiple Sclerosis (MS) and stroke.
At baseline (T0), patients of each group were randomly divided into two arms, with a 1:1 ratio: an 'interventional' group received ARC Intellicare and a 'control' group received a paper-based rehabilitation protocol, both consisting of three 60-minute sessions/week for 8 weeks. Each patient was evaluated by means of clinical scales, gait analysis and stabilometry at baseline (T0) and after the rehabilitation (T2).
All patients (n = 90, 30 per group) showed a significant improvement in clinical scales between T0 and T2. Stroke patients showed a bigger gait improvement in the ARC Intellicare arm, measured both by clinical scales (Tinetti gait p = 0.01) and gait analysis parameters. In PD group, only gait analysis parameters recorded a significant improvement in the active arm.
We demonstrate the safety of ARC Intellicare for home-based rehabilitation in patients with chronic neurological conditions, with high adherence levels. Moreover, in stroke group, it produced more significant improvements of gait compared to paper-based protocol. In the global scenario of the EFS projects promoted by the Italian Ministry of Health, this study is a starting point to conduct this type of studies in Italy.
早期可行性研究（EFS）是对一种设备进行的探索性临床研究，旨在通过早期临床经验中的迭代反馈循环来优化其设计。ARCTRAN研究是一项早期可行性研究，旨在分析与基于纸质运动方案相比，帕金森病（PD）、多发性硬化症（MS）和中风患者使用基于家庭康复设备（ARC Intellicare）方案的疗效、安全性和依从性。
在基线期（T0），每组患者随机分为两组，比例为1:1：“干预”组接受ARC Intellicare，“对照”组接受基于纸质的康复方案，两者均包括每周三次60分钟的疗程，共8周。在基线期（T0）和康复后（T2），通过临床量表、步态分析和稳定测量法对每位患者进行评估。
所有患者（n = 90，每组30例）在T0和T2之间的临床量表上均有显著改善。中风患者在ARC Intellicare组中步态改善更大，这通过临床量表（Tinetti步态p = 0.01）和步态分析参数均得到体现。在帕金森病组中，只有步态分析参数在干预组中有显著改善。
我们证明了ARC Intellicare用于慢性神经疾病患者家庭康复的安全性，且依从性较高。此外，在中风组中，与基于纸质的方案相比，它在步态改善方面更为显著。在意大利卫生部推动的早期可行性研究项目的整体背景下，本研究是在意大利开展此类研究的一个起点。
