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.

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.