Pediatric Rehabilitation Using Socially Assistive Robotics and Virtual Training for Children with Acquired Brain Injury Aged 7 to 16 Years

What this Trial Is About

Researchers are evaluating Inrobics Rehab, a CE-marked medical device that combines socially assistive robotics with virtual training for pediatric rehabilitation. This randomized controlled trial focuses on children aged 7 to 16 years with acquired brain injury ABI. The study aims to assess the usability, user experience, and clinical effectiveness of this interactive, motivating digital environment, hypothesizing improvements in motor, cognitive, and socio-emotional outcomes with good adherence and acceptance. The trial enrolls 30 children divided into two cohorts based on etiology oncological and non-oncological. Participants are randomly assigned to either the experimental arm, which completes 30 sessions over 5 weeks 15 supervised hospital sessions and 15 home-based virtual sessions guided by an interactive avatar on a tablet, or the control arm, which receives no intervention during the trial but follows the same assessments. Hospital sessions occur three times per week for 30 minutes, and home sessions also take place three times weekly, with a 1- to 2-week window allowed to make up missed sessions. Participants undergo assessments at baseline, after the intervention, and at a 3-month follow-up. During hospital sessions, heart rate is monitored, and satisfaction, fatigue, and pain are tracked at each session. Outcomes measured include motor function tests, cognitive and emotional evaluations, quality of life, caregiver burden, and user engagement analytics. Data are pseudonymized and securely stored for at least 10 years, ensuring privacy and compliance with medical device regulations.

Hospital and Home Rehabilitation Based on Social Care Robotics and Artificial Intelligence for Pediatric Patients