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AI-based Model for Rehabilitation Engagement and Motor Performance Evaluation in Pediatric Patients: A Pilot Study

NCT07664033 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2026-06-15
Last updated
2026-06-23

Condition(s) studied

Neuromotor Impairments

Investigational drug(s) / intervention(s)

Artificial Intelligence Model for Rehabilitation Engagement Monitoring

Artificial Intelligence Model for Rehabilitation Engagement Monitoring: The intervention consists of the deployment of a real-time AI-based monitoring system during a standard technology-assisted rehabilitation session. The physiotherapist is provided with a display showing continuous feedback on the patient's engagement levels, emotional state (pleasantness and activation), motor performance, and heart rate. The model processes physiological and inertial data collected via wearable sensors, acting purely as an observational support tool without altering the standard rehabilitation protocol.

Study summary

What is the purpose of this study? This study aims to evaluate the usability and feasibility of an artificial intelligence-based model designed to monitor in real-time the engagement and motor performance of pediatric patients during technology-assisted rehabilitation.

Who can take part? 15 participants between 5 and 17 years old with neuromotor impairments will take part, along with at least 5 of their referring physiotherapists.

What will happen in the study? Each pediatric patient will take part in a single, 1-hour rehabilitation session using either the Lokomat or GRAIL system, according to their standard clinical prescription. During the session, the physiotherapist will have access to a display showing real-time data from the AI model, including the patient's heart rate, engagement level, pleasantness, activation, and motor performance. At the end of the session, the physiotherapist will complete a System Usability Scale (SUS) questionnaire and provide direct feedback on how to improve the model.

Why is this study important? Assessing the usability of this real-time monitoring tool is a necessary step to understand if it is practical for clinical use. Providing therapists with objective, real-time insights into a child's psychological and physical state can ultimately help tailor therapy to the specific needs of each patient, improving the overall rehabilitation experience.

Eligibility

Sex
ALL
Min age
5 Years
Max age
17 Years
Healthy volunteers
No
Inclusion Criteria: * Subjects aged between 5 and 17 years with neuromotor impairments who are undergoing rehabilitation therapy using the Lokomat and GRAIL devices, according to the existing clinical plan. Exclusion Criteria: * Uncooperative subjects.

Primary outcome measure(s)

  • System Usability Scale (SUS) Score — Baseline
    This validated questionnaire is intended to evaluate the usability and feasibility of a system or product. It is composed of 10 items assessing factors such as system complexity, ease of use, and functionality integration. Each item is proposed on a 5-points Likert scale, with minimum value 1 and maximum value 5. Higher overall values stand for a higher degree of agreement with respect to the statement provided by the single item. For odd items, higher values stand for higher usability. For even items, higher values stand for lower usability.

Trial sites (1)

FacilityCityRegionStatus
Scientific Institute IRCCS E.Medea Bosisio Parini Italy
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07664033 on ClinicalTrials.gov ↗ ← All trials in Italy