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

NCT07664033 | Not Yet Recruiting

• 2 other identifiers: L2-246-F2RC 2024-2026 to E. Biffi
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neuromotor Impairments

Keywords

Engagement; Pediatric Rehabilitation; Neuromotor Impairments; Gait; Heart Rate Variability; Electrodermal Activity

Outcome Measures

Primary Outcomes (1)

• System Usability Scale (SUS) Score

  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.

  Baseline

Secondary Outcomes (2)

• Service Provider-Rated Measure of Client Engagement (PRIME-SP)

  Baseline

• AI Model-Inferred Engagement Level

  Baseline

Study Arms (1)

Real-Time Engagement Monitoring

EXPERIMENTAL

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

Interventions

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.

Real-Time Engagement Monitoring

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Uncooperative subjects.

Sponsors & Collaborators

• IRCCS Eugenio Medea: lead
• Politecnico di Milano: collaborator

Study Sites (1)

Scientific Institute IRCCS E.Medea

Bosisio Parini, 23842, Italy

Location

Related Publications (5)

• Bray L, Appleton V, Sharpe A. The information needs of children having clinical procedures in hospital: Will it hurt? Will I feel scared? What can I do to stay calm? Child Care Health Dev. 2019 Sep;45(5):737-743. doi: 10.1111/cch.12692. Epub 2019 Jul 18.

  PMID: 31163093 BACKGROUND

• Flynn R, Walton S, Scott SD. Engaging children and families in pediatric Health Research: a scoping review. Res Involv Engagem. 2019 Nov 4;5:32. doi: 10.1186/s40900-019-0168-9. eCollection 2019.

  PMID: 31700676 BACKGROUND

• Graffigna G, Barello S, Riva G, Castelnuovo G, Corbo M, Coppola L, Daverio G, Fauci A, Iannone P, Ricciardi W, Bosio AC; CCIPE Working Group. [Recommandation for patient engagement promotion in care and cure for chronic conditions.]. Recenti Prog Med. 2017 Nov;108(11):455-475. doi: 10.1701/2812.28441. Italian.

  PMID: 29149163 BACKGROUND

• Koenig A, Omlin X, Zimmerli L, Sapa M, Krewer C, Bolliger M, Muller F, Riener R. Psychological state estimation from physiological recordings during robot-assisted gait rehabilitation. J Rehabil Res Dev. 2011;48(4):367-85. doi: 10.1682/jrrd.2010.03.0044.

  PMID: 21674389 BACKGROUND

• Costantini S, Falivene A, Chiappini M, Malerba G, Dei C, Bellazzecca S, Storm FA, Andreoni G, Ambrosini E, Biffi E. Artificial intelligence tools for engagement prediction in neuromotor disorder patients during rehabilitation. J Neuroeng Rehabil. 2024 Dec 19;21(1):215. doi: 10.1186/s12984-024-01519-2.

  PMID: 39702317 BACKGROUND

Central Study Contacts

Fabio Alexander Storm, PhD

CONTACT

+39 031877111; fabio.storm@lanostrafamiglia.it

Simone Costantini, MSc

CONTACT

simone.costantini@lanostrafamiglia.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 23, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: June 23, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

IT (1)