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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Acquired Brain Injury
• Intervention / Treatment: Device: Robot-assisted, gamified pediatric upper-limb rehabilitation (hybrid clinic + home program)

Detailed Description

This study describes a randomized controlled clinical trial designed to evaluate the usability, user experience, and clinical effectiveness of Inrobics Rehab, a pediatric rehabilitation solution based on Socially Assistive Robotics (SAR) and Artificial Intelligence, in children and adolescents with Acquired Brain Injury (ABI) aged 7-16 years. The rationale is that SAR and virtual training can provide an interactive and motivating environment that may increase engagement and adherence, while enabling controlled, monitored exercises and objective follow-up of progress; however, evidence in pediatric ABI remains limited. The study hypothesis is that Inrobics Rehab can improve motor, cognitive, and socio-emotional outcomes in this population, while delivering a positive user experience with good usability and high adherence.

The study is planned as an experimental, longitudinal, prospective, controlled, randomized clinical trial using a CE-marked medical device (Inrobics Rehab; CE Class I, registration no. RPS/777/2021). It is embedded in a 36-month collaborative research project involving INROBICS, the Hospital Nacional de Parapléjicos, and the Hospital Infantil Universitario Niño Jesús (HIUNJ), where HIUNJ plays a central role in patient selection, clinical assessments, delivery of therapy sessions, and clinical data collection in a real-world hospital setting.

Participants will be pediatric patients with confirmed ABI receiving care at the HIUNJ Rehabilitation Service. Eligibility requires: age 7-16 years; sufficient comprehension to follow basic instructions and participate actively; confirmed acquired brain injury; clinical stability to engage in therapy; and ability to maintain independent sitting, with or without assistive supports (e.g., belts, wedges, trunk supports). Key exclusion criteria include unstable orthopedic injuries in the upper limbs (e.g., non-consolidated fractures or unstable osteosynthesis), severe pain/rigidity and/or severe upper-limb spasticity, severe pulmonary or cardiac disease requiring constant monitoring during exercise, a history of abnormal response to physical effort prior to ABI, severe visual impairment, severe cognitive impairment and/or disabling psychiatric disease, or any other condition judged by the medical team to prevent safe participation. The protocol emphasizes enhanced protection measures for this vulnerable population through reinforced consent/assent procedures, strict selection criteria, monitoring, and additional risk minimization.

A total sample of 30 pediatric ABI participants is planned, split into two etiological cohorts to support balanced comparisons: 15 with oncological etiology and 15 with non-oncological etiology. Initial selection is by convenience sampling among eligible patients routinely followed at HIUNJ; subsequently, within each etiological subgroup, participants are randomly allocated to an experimental or control arm, with approximately half in each arm. Randomization is implemented using sequentially numbered sealed envelopes containing group assignment (control vs intervention), based on a computer-generated random list; hospital evaluators remain blinded to group allocation to support objectivity in outcome collection. The protocol acknowledges that the theoretically estimated sample size to detect moderate effects would be larger, but justifies feasibility constraints and the relevance of the proposed sample in the context of pediatric SAR studies.

The experimental intervention consists of a structured rehabilitation program delivered through Inrobics Rehab Clinic (hospital) and Inrobics Rehab Virtual (home). The program includes 30 total sessions over 5 weeks of active intervention, distributed equally between 15 in-hospital sessions and 15 home-based virtual sessions, delivered in an alternating manner (weeks combining clinic and virtual work) to allow progressive adaptation while maintaining continuous clinical follow-up. Each hospital session lasts 30 minutes, with a planned frequency of 3 sessions per week, programmed and directed by a professional using the clinical platform and supervised throughout. In the home phase, participants complete 3 sessions per week via the virtual platform on a tablet, following exercises prescribed by the clinician and guided by an interactive virtual avatar; gamification elements are included to enhance motivation and participation, and the system records objective metrics to support monitoring of therapeutic progress and adaptation. A contingency window of ±2 additional weeks is allowed solely to recover missed sessions due to justified absences, without extending beyond this limit, to preserve a homogeneous "dose" of intervention and the internal validity of the design.

The control arm receives no therapeutic intervention within the trial; control participants complete the same evaluation schedule as the experimental group to enable between-group comparisons and help isolate the effect of the robotics/virtual intervention from external factors. To ensure fairness, the protocol includes a post-trial access option for control participants: after the clinical trial ends, they may access Inrobics Rehab Virtual for 1-3 months through a temporary license, or opt to undergo the full intervention program (hospital + home phases) if desired. At study completion, all participants in both groups receive an individualized final report summarizing assessment results over the program.

Outcome assessment is scheduled at baseline (pre-intervention), immediately after the intervention period (post-intervention at ~5 weeks for the intervention arm; at a comparable timepoint for controls), and at 3 months follow-up to determine whether observed changes are maintained. In addition, during the intervention, session-by-session ratings of satisfaction, fatigue, and/or pain are collected (hospital and home), and user-experience parameters are continuously recorded by the platform; heart rate is monitored only during hospital sessions. A dedicated Case Report Form (CRF) is included as an annex to standardize data capture and organization.

The protocol defines a broad set of outcomes covering motor performance, cognition/emotional status, health perception and burden, and usability/user experience. Motor efficacy is assessed using standardized measures including trunk control (Trunk Control Measurement Scale, TCMS), manual dexterity (Box & Block, complemented by Leap Motion measures), and manual function (ABILHAND-Kids, with optional Jebsen-Taylor), as well as dominance (Edinburgh inventory) and upper-limb strength (Daniels and/or dynamometry). Neuropsychological and emotional domains include visual attention (perception/difference or "faces" tests), working memory (WISC-V digit span), depressive symptoms (Children's Depression Inventory for those under 14), anxiety (STAIC), and executive functioning (EFE inventory). Health perception and burden include pediatric quality of life (EQoL-5D-Y5L), pain (VAS), fatigue (EPInfant), and caregiver burden (Zarit). Usability and user experience are examined using both questionnaires and platform analytics, such as motor accuracy, reaction time, engagement (e.g., whether the user remains oriented toward the platform/tablet), aggregated performance metrics, and execution speed; physiological response to effort is assessed with heart-rate monitoring using Polar Verity Sense during hospital sessions. Satisfaction is assessed via SAM (child) and QUEST 2.0 (caregiver), and involvement/adherence-related constructs include a Hopkins measure of engagement with the training program.

Planned analyses include descriptive statistics and inferential comparisons across timepoints and between groups, selecting methods based on variable type and distribution, with standard significance thresholds; the protocol also identifies potential biases such as limited sample size, subjectivity in self-reported scales, and potential attrition particularly during the home phase.

Ethical conduct and data protection are addressed in line with relevant regulations and the specific needs of pediatric participants. The study is conducted according to the Declaration of Helsinki, and participation requires formal informed consent (with the option to withdraw at any time without affecting usual care). Data are pseudonymized using a sequential alphanumeric code assigned by inclusion order; all questionnaires, clinical measures, physiological records, and platform data are labeled only with this identifier, while the code-to-identity link is stored separately with restricted access. Pseudonymized datasets for analysis are stored in the institutional OneDrive environment with restricted, credential-based access, and cross-site data sharing is limited to pseudonymized information through controlled shared folders with the sponsor (INROBICS). Documentation generated for the clinical investigation is retained for at least 10 years after study completion (and potentially longer depending on applicable medical device regulatory requirements and market placement), with measures to ensure integrity, accessibility, and protection against loss, alteration, or unauthorized access.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: José Carlos Pulido, Engineering; Phone Number: +34 630423231; Email: jcpulido@inrobics.com
• Study Contact Backup: Name: Fuensanta García, Medical device expert; Phone Number: +34 630423231; Email: fgarcia@inrobics.com

Study Locations

• Spain
  • Madrid, Spain, 28009
    • Hospital Infantil Universitario Niño Jesús
    • Contact: Serafín Rodríguez, Principal investigator; Phone Number: +34 91 503 59 00; Email: serafin.rodriguez@salud.madrid.org
    • Contact: José Carlos Pulido, Engineer; Phone Number: +34 630 42 32 31; Email: jcpulido@inrobics.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Inrobics; 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); 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.
No Intervention: No Inrobics; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, week 5, and month 3.
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.	Baseline, week 5, and month 3.
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.	Baseline, week 5, and month 3.
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.	Baseline, week 5, and month 3.
Handedness assessed by the Edinburgh Handedness Inventory.	Hand dominance will be assessed using the Edinburgh Handedness Inventory at study entry.	Baseline.
Change from baseline in upper limb muscle strength assessed by manual muscle testing (Daniels).	Upper limb muscle strength will be assessed using the Daniels manual muscle testing scale. Muscle strength is graded from 0 (no visible contraction) to 5 (normal strength against full resistance). Higher scores indicate greater strength.	Baseline, week 5, and month 3.
Change from baseline in upper limb muscle strength assessed by Dynamometry.	Upper limb muscle strength will be assessed using dynamometry during clinical evaluation. Higher values indicate greater muscle strength.	Baseline, week 5, and month 3.
Change from baseline in visual attention assessed by the "Faces Test".	Visual attention will be assessed using the "Faces Test". Higher scores indicate better visual attention performance.	Baseline, week 5, and month 3.
Change from baseline in working memory assessed by WISC-V Digit Span.	Working memory will be assessed using the Digit Span subtest of the Wechsler Intelligence Scale for Children (WISC-V). Higher scores indicate better working memory performance.	Baseline, week 5, and month 3.
Change from baseline in depressive symptoms assessed by the Children's Depression Inventory (CDI).	Depressive symptoms will be assessed using the CDI. Higher scores indicate greater depressive symptomatology.	Baseline, week 5, and month 3.
Change from baseline in anxiety assessed by the State-Trait Anxiety Inventory for Children (STAIC).	Anxiety will be assessed using the STAIC. Higher scores indicate greater anxiety.	Baseline, week 5, and month 3.
Change from baseline in executive function assessed by the Executive Function Inventory (EFE).	Executive functioning will be assessed using the EFE. Higher scores indicate greater executive difficulties.	Baseline, week 5, and month 3.
Change from baseline in health-related quality of life assessed by EQ-5D-Y-5L.	Health-related quality of life will be assessed using the EQ-5D-Y-5L questionnaire. Higher index values indicate better perceived health status.	Baseline, week 5, and month 3.
Change from baseline in caregiver burden assessed by the Zarit Burden Interview.	Caregiver burden will be assessed using the Zarit Burden Interview. Higher scores indicate greater caregiver burden.	Baseline, week 5, and month 3.
Pain intensity during rehabilitation sessions assessed by Visual Analog Scale (VAS).	Pain intensity will be assessed using a VAS ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicate greater pain intensity.	During each intervention session (weeks 1-5).
Fatigue during rehabilitation sessions assessed by EPInfant.	Fatigue will be assessed using the EPInfant (Effort Perception for Children) scale during intervention sessions. Higher scores indicate greater perceived fatigue.	During each intervention session (weeks 1-5).
Motor accuracy recorded by Inrobics Rehab Platform during intervention.	Motor accuracy will be automatically recorded by the Inrobics Rehab digital platform during training sessions.	During each intervention session (weeks 1-5).
Reaction time recorded by Inrobics Rehab Platform during intervention.	Reaction time will be automatically recorded by the Inrobics Rehab digital platform during training sessions.	During each intervention session (weeks 1-5).
Engagement recorded by Inrobics Rehab Platform during intervention	Engagement will be automatically recorded by the Inrobics Rehab digital platform during training sessions.	During each intervention session (weeks 1-5)
Performance per activity recorded by Inrobics Rehab Platform during intervention.	Performance per activity will be automatically recorded by the Inrobics Rehab digital platform during training sessions.	During each intervention session (weeks 1-5).
Execution speed recorded by Inrobics Rehab Platform during intervention.	Execution speed will be automatically recorded by the Inrobics Rehab digital platform during training sessions.	During each intervention session (weeks 1-5).
Heart Rate during hospital-based rehabilitation sessions	Heart rate will be monitored using a Polar Verity Sense optical sensor during hospital-based rehabilitation sessions.	During hospital sessions (weeks 1-5).
Engagement with the training program assessed by Hopkins Scale.	Engagement with the training program will be assessed using the Hopkins scale at the end of the intervention.	Week 5.
Satisfaction with the intervention assessed by Self-Assessment Manikin (SAM).	Emotional response to the intervention will be assessed using the SAM.	Week 5.
Change from baseline in satisfaction assessed by the Quebec User Evaluation of Satisfaction With Assistive Technology (QUEST 2.0).	Satisfaction with assistive technology will be assessed using the QUEST 2.0, a standardized questionnaire evaluating user satisfaction with assistive devices and related services. Higher scores indicate greater satisfaction.	Week 5.

Collaborators and Investigators

• Sponsor: Inrobics Social Robotics, S.L.
• Collaborators: Hospital Infantil Universitario Niño Jesús, Madrid, Spain; Fundación para la investigación biomética Hospital Infantil Universitario Niño Jesús
• Investigators: Principal Investigator: Serafín Rodríguez, Hospital Infantil Universitario Niño Jesús

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: January 13, 2026
• First Submitted That Met QC Criteria: March 3, 2026
• First Posted (Actual): March 4, 2026

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: March 3, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Telemedicine; Oncology; Neurorehabilitation; Acquired Brain Injury; Social Robots; Children with Disability
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Neoplasms; Brain Injuries
• Other Study ID Numbers: CPP2023-010566; R-0024/25 (Other Identifier: CEIm Hospital Universitario Niño Jesús)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared outside the study team. Access to data is restricted to the hospital and the consortium partner involved in the study, exclusively for the purposes of this research and under applicable data protection regulations. The data will not be used for other purposes, shared with third parties, or deposited in repositories. Only de-identified aggregate results will be reported in scientific publications.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No