Hospital and Home Rehabilitation Based on Social Care Robotics and Artificial Intelligence for Pediatric Patients
Trial ID: NCT07448103
Status: NOT_YET_RECRUITING
Study type: INTERVENTIONAL
Phase: NA
Start date: 2026-02-01
Completion date: 2027-02
Sponsor: Inrobics Social Robotics, S.L.
Collaborators: Fundación para la investigación biomética Hospital Infantil Universitario Niño Jesús; Hospital Infantil Universitario Niño Jesús, Madrid, Spain
Conditions: Acquired Brain Injury
Interventions: Robot-assisted, gamified pediatric upper-limb rehabilitation (hybrid clinic + home program)
Locations: Hospital Infantil Universitario Niño Jesús
Countries: Spain
Enrollment: 30
Age range: 7 Years - 16 Years
Sex: ALL

Summary:
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 enrolled by convenience sampling and randomized within each cohort to experimental or control arms (about half per arm) using sequentially numbered sealed envelopes based on a computer-generated random list. Outcome assessors are intended to remain blinded to allocation.

The experimental arm completes 30 sessions over 5 weeks: 15 supervised in-hospital sessions (Inrobics Rehab Clinic) and 15 home-based sessions (Inrobics Rehab Virtual). Hospital sessions are delivered three times per week for 30 minutes. Home sessions are completed three times per week on a tablet, guided by an interactive avatar, with gamification and automatic collection of performance metrics; a ±2-week window is allowed only to make up missed sessions. The control arm receives no intervention and undergoes evaluations at comparable timepoints; after study completion, controls may access the virtual platform for 1-3 months or complete the full program.

Assessments occur at baseline, post-intervention, and 3-month follow-up, with session-level monitoring of satisfaction, fatigue and/or pain. Heart rate is monitored only during hospital sessions (Polar Verity Sense). Outcomes include motor function (TCMS, Box \& Block, ABILHAND-Kids), neuropsychological and emotional measures (attention, working memory, depression/anxiety, executive functioning), health perception and burden (EQoL-5D-Y5L, pain VAS, fatigue, caregiver burden), and usability/engagement analytics (accuracy, reaction time, engagement, execution speed). Data will be pseudonymized, stored securely with restricted access, and retained for at least 10 years (or longer if required by medical device regulations).

Eligibility criteria:
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.

Outcomes:
Change from baseline in Trunk Control Measurement Scale (TCMS) Score