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

RecruitingNAAges 7 Years - 16 YearsAllInrobics Social Robotics, S.L.
NCT07448103 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This study describes a prospective, longitudinal, randomized controlled trial evaluating Inrobics Rehab, a CE-marked Class I medical device (reg. RPS/777/2021) that combines socially assistive robotics with virtual training for pediatric rehabilitation. The trial will assess usability, user experience, and clinical effectiveness. It is based on the premise that an interactive, motivating, monitored digital environment can improve engagement and adherence while enabling objective tracking of progress. The main hypothesis is that Inrobics Rehab will enhance motor, cognitive, and socio-emotional outcomes in children with acquired brain injury (ABI) and will be well accepted by users. Participants will be children aged 7-16 years with confirmed ABI, adequate comprehension to follow instructions, clinical stability, and the ability to maintain sitting (with or without supports). Exclusion cr

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📋 Eligibility rules (as published)
Inclusion Criteria: * Children/adolescents 7-16 years with confirmed acquired brain injury * Clinically stable * Able to understand and follow basic instructions * Able to maintain sitting independently (with or without postural supports) Exclusion Criteria: * Unstable upper-limb orthopedic injuries (e.g., non-consolidated fractures/unstable osteosynthesis). * Severe pain/rigidity and/or severe upper-limb spasticity * Severe pulmonary or cardiac disease requiring constant monitoring * History of abnormal response to exertion prior to acquired brain injury * Severe visual impairment, severe cognitive impairment or disabling psychiatric disease, or any other condition that makes participation unsafe or not feasible per the medical team.
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What it tests

  • Robot-assisted, gamified pediatric upper-limb rehabilitation (hybrid clinic + home program)
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Where

1 site
Hospital Infantil Universitario Niño Jesús
Madrid, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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