AI-based Model for Rehabilitation Engagement and Motor Performance Evaluation in Pediatric Patients: A Pilot Study
Neuromotor Impairments
De qué trata este estudio
El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.
- Tipo de estudio
- De intervención
- Fase
- No aplica
- Rango de edad
- 5 años - 17 años
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 15 Estimado
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
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Acerca de la investigación
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.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
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.
Tratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- No aplica
- Enmascaramiento
- Sin enmascaramiento
Real-Time Engagement Monitoring
Participants in this experimental arm, consisting of pediatric patients with neuromotor impairments, will undergo a single 1-hour technology-assisted rehabilitation session using either the Lokomat or GRAIL system. During the session, the physiotherapist will use a display showing real-time outputs from the AI-based model, including the patient's heart rate, engagement levels, pleasantness, activation, and motor performance. The model acts as an observational support tool and will not directly alter the standard rehabilitation protocol. At the end of the session, the physiotherapist will evaluate the usability of the system.
Device: Artificial Intelligence Model for Rehabilitation Engagement Monitoring
Artificial Intelligence Model for Rehabilitation Engagement Monitoring DEVICE
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.
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
System Usability Scale (SUS) Score
Plazo: 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.
Medidas secundarias
Service Provider-Rated Measure of Client Engagement (PRIME-SP)
Plazo: Baseline
This measure is intended to capture the therapist's observation of patient engagement. PRIME-SP is a validated self-reported questionnaire that is composed of three main parts: Part A, where the therapist can perform an overall evaluation of patient engagement according to a 5-point Likert scale (from 0 to 4, with higher values corresponding to positive engagement); Part B, where the therapist can perform a domain-dependent (affective, cognitive, behavioral domains) evaluation of patient engagement according to a 5-point Likert scale (from 0 to 4, with higher values corresponding to positive engagement); Part C, where the therapist can take free notes about factors and circumstances that he/she believes may have affected patient engagement in the session.
AI Model-Inferred Engagement Level
Plazo: Baseline
This objective measure is intended to capture the patient's continuous engagement level during the rehabilitation session. The AI-based model infers the engagement state using feed-forward neural networks that process real-time physiological data (such as HRV and EDA) and inertial signals (IMU). The model provides a categorical evaluation of engagement (low vs high).
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (1)
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1 centros
Scientific Institute IRCCS E.MedeaBosisio Parini, ItalyReclutando
Equipo y fechas
- Patrocinador principal
- IRCCS Eugenio Medea
- Inicio del estudio
- 24 jun 2026 Real
- Finalización primaria
- 31 dic 2026 Estimado
- Finalización del estudio
- 31 dic 2026 Estimado
- Primera publicación
- 23 jun 2026 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
AI-based Model for Rehabilitation Engagement and Motor Performance Evaluation in Pediatric Patients
Consulta a Wellness Clinical Research
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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026