Condition: Acquired Brain Injury · Sponsor: Inrobics Social Robotics, S.L.
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 criteria include unstable upper-limb orthopedic injuries; severe pain, rigidity, or severe upper-limb spasticity; severe cardiopulmonary disease requiring constant monitoring; abnormal pre-ABI response to exertion; severe visual or cognitive impairment; disabling psychiatric disease; or any condition preventing safe participation. Additional safeguards are included due to the pediatric/vulnerable population. Thirty participants will be recruited at Hospital Infantil Universitario Niño Jesús and split into two etiological cohorts (15 oncological, 15 non-oncological). Eligible patients will be en…
This description comes directly from the study's public registry record.
José Carlos Pulido, Engineering · +34 630423231 · jcpulido@inrobics.com
Fuensanta García, Medical device expert · +34 630423231 · fgarcia@inrobics.com
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| Hospital Infantil Universitario Niño Jesús | Madrid, Madrid, Spain | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07448103