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

NCT07448103 | Not Yet Recruiting

• 2 other identifiers: CPP2023-010566R-0024/25
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Acquired Brain Injury

Keywords

Acquired Brain Injury; Social Robots; Neurorehabilitation; Children with Disability; Telemedicine; Oncology

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (pre-intervention), end of intervention (post; after 5 weeks), and 3-monthfollow-up.

Secondary Outcomes (25)

• Change from baseline in Box and Block Test Score.

  Baseline, week 5, and month 3.

• Change from baseline in upper limb movement metrics assessed by Leap Motion.

  Baseline, week 5, and month 3.

• Change from baseline in manual ability assessed by ABILHAND-Kids.

  Baseline, week 5, and month 3.

• Change from baseline in hand function assessed by the Jebsen-Taylor Hand Function Test.

  Baseline, week 5, and month 3.

• Handedness assessed by the Edinburgh Handedness Inventory.

  Baseline.

Study Arms (2)

Inrobics

EXPERIMENTAL

Participants assigned to the intervention arm will complete a structured pediatric rehabilitation program totaling 30 sessions over \~5 weeks. They will alternate 15 supervised in-hospital sessions (Inrobics Rehab Clinic; 30 minutes, 3 sessions/week) with 15 home-based virtual sessions (Inrobics Rehab Virtual; 3 sessions/week) performed on a tablet and guided by an interactive avatar. The virtual training incorporates gamified tasks and automatically records objective performance metrics (e.g., accuracy, reaction time, execution speed) to support clinician follow-up and individualized progression. A ±2-week make-up window is allowed only to recover missed sessions due to justified absences, without extending beyond that limit.

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

No Inrobics

NO INTERVENTION

Participants randomized to the control arm will receive no study intervention and will continue with usual care outside the trial. They will complete the same assessment schedule as the intervention group (baseline, post-intervention timepoint, and 3-month follow-up) to allow comparison of outcomes over time. After trial completion, control participants may be offered temporary access to Inrobics Rehab Virtual (about 1-3 months) or the option to undertake the full program, depending on preference and availability.

Interventions

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

The 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.

Inrobics

Eligibility Criteria

• Age: 7 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Inrobics Social Robotics, S.L.: lead
• Fundación para la investigación biomética Hospital Infantil Universitario Niño Jesús: collaborator
• Hospital Infantil Universitario Niño Jesús, Madrid, Spain: collaborator

Study Sites (1)

Hospital Infantil Universitario Niño Jesús

Madrid, 28009, Spain

Location

Related Links

• Website of the study sponsor providing information on the clinical studies it is conducting

MeSH Terms

Conditions

Brain Injuries; Neoplasms

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Serafín Rodríguez

  Hospital Infantil Universitario Niño Jesús

  PRINCIPAL INVESTIGATOR

Central Study Contacts

José Carlos Pulido, Engineering

CONTACT

+34 630423231; jcpulido@inrobics.com

Fuensanta García, Medical device expert

CONTACT

+34 630423231; fgarcia@inrobics.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a prospective, longitudinal, parallel-group randomized controlled trial in children aged 7-16 years with acquired brain injury. After baseline assessment, participants are stratified by etiology (oncological vs non-oncological) and randomized (sealed, sequential envelopes from a computer-generated list) to either (1) Inrobics Rehab or (2) control. The intervention delivers a fixed "dose" of 30 sessions over 5 weeks: 15 supervised 30-min hospital sessions (3/week) using Inrobics Rehab Clinic alternated with 15 home sessions (3/week) on a tablet via Inrobics Rehab Virtual guided by an avatar with gamification; a ±2-week window is allowed only to make up missed sessions. Controls receive no study therapy but complete identical assessments; assessors are blinded, with outcomes measured post-treatment and at 3-month follow-up.

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: March 4, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)