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).
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)
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
Parallel
Robot-assisted, gamified pediatric upper-limb rehabilitation (hybrid clinic + home program)
DeviceThe intervention is a hybrid pediatric rehabilitation program delivered through a socially assistive robotics-based virtual training platform. Participants complete 30 sessions over \~5 weeks, alternating 15 supervised in-hospital sessions (30 minutes, 3/week) led by a therapist using the clinical version, with 15 home-based sessions (3/week) on a tablet using the virtual version guided by an avatar. Training consists of gamified upper-limb and postural control activities prescribed and adjusted by the clinician, with automatic logging of objective performance (e.g., accuracy, reaction time, execution speed, engagement) to support monitoring and progression. A ±2-week window is allowed only to make up missed sessions due to justified absences; heart rate is recorded during hospital sessions.
Change from baseline in Trunk Control Measurement Scale (TCMS) Score
Trunk control will be assessed using TCMS, a clinical scale evaluating static and dynamic sitting balance and selective trunk movement control. Higher scores indicate better trunk control.
Change from baseline in Box and Block Test Score.
Manual dexterity will be assessed using the Box and Block Test, which measures the number of blocks transferred within a fixed time period. Higher scores indicate better manual dexterity.
Change from baseline in upper limb movement metrics assessed by Leap Motion.
Upper limb movement during standardized motor tasks will be recorded using the Leap Motion sensor. Metrics are automatically captured by the system.
Change from baseline in manual ability assessed by ABILHAND-Kids.
Manual ability in daily activities will be assessed using the ABILHAND-Kids questionnaire completed by caregivers. Higher scores indicate better perceived manual ability.
Change from baseline in hand function assessed by the Jebsen-Taylor Hand Function Test.
Hand function will be assessed using the Jebsen-Taylor Hand Function Test, which measures the time (in seconds) required to complete standardized manual tasks. Shorter completion times indicate better hand function.
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Inrobics Social Robotics, S.L.
Lead sponsor
Fundación para la investigación biomética Hospital Infantil Universitario Niño Jesús
Collaborator
Hospital Infantil Universitario Niño Jesús, Madrid, Spain
Collaborator
