ACT-ON-DIP: Study Protocol of a Randomized Controlled Trial of a Home-Based ACTion Observation Tele-RehabilitatioN for Upper Limb in Children with DIPlegic Cerebral Palsy.
Elena Beani, Elisa Matteucci, Elisa Sicola, Giada Martini, Maria Chiara Di Lieto, Clara Bombonato, Valentina Menici, Annalisa Cotardo, Marta Rizzo, Silvia Filogna, Federica Camuncoli, Laura Biagi, Giovanni Cioni, Francesca Fedeli, Chiara Gelmini, Rita Neviani, Olivia Vecchi, Silvia Perazza, Silvia Faccioli, Antonino Errante, Alessandro Piras, Eleonora Sicuri, Francesca Bozzetti, Roslyn N Boyd, Adriano Ferrari, Leonardo Fogassi, Giuseppina Sgandurra
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引用次数: 0
Abstract
Background: Children with diplegic Cerebral Palsy often exhibit upper-limb (UL) motor impairments compounded by deficits in visuospatial, sensory, and executive functions. Despite this, research has primarily focused on lower-limb rehabilitation, leaving the treatment of UL function in diplegic Cerebral Palsy underexplored. Action Observation Therapy (AOT), based on Mirror Neuron System activation, has shown promise in promoting motor recovery, but evidence specific to this population is limited. This exploratory randomized controlled trial (RCT) aims to assess the feasibility and effectiveness of a home-based AOT program-ACT ON DIP-for improving upper-limb function in children and adolescents with diplegic Cerebral Palsy. Methods: Fifty-four participants with spastic diplegic Cerebral Palsy (MACS and GMFCS levels I-III, aged 5-16 years) will be randomly assigned to an experimental group (receiving an 8-week home-based AOT program) or a control group (receiving standard care). The ACT ON DIP system includes an ad hoc software, kits of objects for daily tasks, and wearable sensors. The system allows for delivering structured uni- and bimanual AOT activities tailored to the child's profile. Primary outcome is the Both Hands Assessment (BoHA); secondary outcomes include motor (MA-2, BBT, ABILHAND), neuropsychological (NEPSY-II, Corsi Test, BRIEF), and participation measures (COPM, PEM-CY, CP-QOL). A subgroup will undergo fMRI to explore neural correlates of training-related changes. Results: Feasibility, compliance, and user experience with the home-based system will be assessed. This study will evaluate short-, medium-, and long-term changes in UL performance and related neuropsychological functions. Conclusions: ACT ON DIP represents a novel, personalized, and accessible tele-rehabilitation intervention for children with diplegic Cerebral Palsy. If effective, it could expand treatment opportunities for UL rehabilitation in this population and support broader implementation of home-based AOT.
背景：患有双瘫性脑瘫的儿童通常表现为上肢（UL）运动障碍并伴有视觉空间、感觉和执行功能的缺陷。尽管如此，研究主要集中在下肢康复方面，对双瘫性脑瘫患者UL功能的治疗探索不足。基于镜像神经元系统激活的动作观察疗法（AOT）已显示出促进运动恢复的希望，但针对这一人群的证据有限。本探索性随机对照试验（RCT）旨在评估以家庭为基础的辅助辅助治疗项目- act ON dip -改善儿童和青少年双瘫性脑瘫上肢功能的可行性和有效性。方法：54名患有痉挛性双瘫性脑瘫（MACS和GMFCS等级为I-III，年龄5-16岁）的参与者将被随机分配到实验组（接受为期8周的家庭辅助护理计划）或对照组（接受标准护理）。ACT ON DIP系统包括一个特别的软件、用于日常任务的物品套件和可穿戴传感器。该系统允许根据孩子的情况提供结构化的单手和双手AOT活动。主要结果是双手评估（BoHA）；次要指标包括运动指标（MA-2、BBT、ABILHAND）、神经心理指标（NEPSY-II、Corsi Test、BRIEF）和参与指标（COPM、PEM-CY、CP-QOL）。一个小组将接受功能磁共振成像来探索训练相关变化的神经相关性。结果：将评估基于家庭的系统的可行性、依从性和用户体验。本研究将评估短期、中期和长期UL表现和相关神经心理功能的变化。结论：ACT ON DIP是一种新型的、个性化的、可获得的远程康复干预方法，适用于双瘫性脑瘫儿童。如果有效，它可以扩大这一人群的UL康复治疗机会，并支持更广泛地实施以家庭为基础的辅助门诊治疗。
期刊介绍：
Children is an international, open access journal dedicated to a streamlined, yet scientifically rigorous, dissemination of peer-reviewed science related to childhood health and disease in developed and developing countries.
The publication focuses on sharing clinical, epidemiological and translational science relevant to children’s health. Moreover, the primary goals of the publication are to highlight under‑represented pediatric disciplines, to emphasize interdisciplinary research and to disseminate advances in knowledge in global child health. In addition to original research, the journal publishes expert editorials and commentaries, clinical case reports, and insightful communications reflecting the latest developments in pediatric medicine. By publishing meritorious articles as soon as the editorial review process is completed, rather than at predefined intervals, Children also permits rapid open access sharing of new information, allowing us to reach the broadest audience in the most expedient fashion.
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