AI-based Model for Rehabilitation Engagement and Motor Performance Evaluation in Pediatric Patients

NCT06993389 | Recruiting

• 2 other identifiers: L2-246RC 2024-2026 to E. Biffi
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

What is the purpose of this study? This study wants to learn how the physiological signals and movement data can help researchers understand and predict how children with neuromotor impairments engage with rehabilitation. Who can take part? 40 participants between 5 and 17 years old will take part. Half of them will be children with neurotypical development (control). The other half will be children with neuromotor impairments. What will happen in the study? Children within the control group will take part in 1 rehabilitation session, while those with neuromotor impairments will take part in 2 to 3 rehabilitation sessions as part of the treatment plan already provided by their referring physicians. During each session, researchers will collect: (i) physiological signals like heart activity (ECG), heart rate variability (HRV), and electrodermal activity (EDA); (ii) movement data; (iii) exergames scores and motor performance data; (iv) questionnaires filled out by therapists to understand how engaged the participant is. Children will use one of two technology-assisted rehabilitation systems during their sessions: either the Lokomat (robotic exoskeleton that supports children with impairments in walking) or the GRAIL system (a treadmill system with motion tracking and extended reality). Why is this study important? Researchers will use the data to understand and predict how each child responds to therapy and engage with it. These analyses will help therapists adjust rehabilitation settings in real-time, offering more personalized and effective care for children with neuromotor impairments.

Conditions

Neuromotor Impairments

Keywords

Engagement; Motor rehabilitation; Neuromotor impairments; Gait; Psychophysiology

Outcome Measures

Primary Outcomes (1)

• Pediatric Rehabilitation Intervention Measure of Engagement - Observation (PRIME-O)

  This validated self-reported questionnaire is intended to capture observable indicators of patient and therapist engagement in therapy sessions. It is composed of 10 items, divided into 3 sections. Section A (4 items) groups items exclusively related to the patient engagement evaluation, Section B (4 items) lists items exclusively devoted to therapists, Section C (2 items) contains items that evaluate the interaction between patient and therapist. Each item is proposed on a 5-points Likert scale, with minimum value 0 and maximum value 4. Higher values stand for higher engagement levels.

  Baseline

Secondary Outcomes (13)

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

  Baseline

• Self-Assessment Manikin (SAM)

  Baseline

• Positive Affect and Negative Affect Scale (PANAS)

  Baseline

• Heart Rate (HR)

  Baseline

• Root Mean Square of Successive Differences (RMSSD)

  Baseline

Study Arms (2)

Neuromotor impaired

Other: Inapplicable

Control

Other: Inapplicable

Interventions

Inapplicable OTHER

Inapplicable

Control; Neuromotor impaired

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Potentially eligible participants will be selected from clinical databases of IRCCS Medea.

You may qualify if:

• Subjects aged between 5 and 17 with typical development.
• 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, LC, 23842, Italy

RECRUITING

Related Publications (5)

• 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

• 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

• 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

• 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

• 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

Central Study Contacts

Fabio A Storm, PhD

CONTACT

+39 031877111; fabio.storm@lanostrafamiglia.it

Simone Costantini, MSc

CONTACT

simone.costantini@lanostrafamiglia.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: May 28, 2025
• Study Start: June 9, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

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

Locations

IT (1)