AI-based Model for Rehabilitation Engagement and Motor Performance Evaluation in Pediatric Patients
NCT ID: NCT06993389
Last Updated: 2025-07-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
40 participants
OBSERVATIONAL
2025-06-09
2025-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Implementation of a New Motor Skill Learning Therapeutic Device in Children With Cerebral Palsy Rehabilitation
NCT03930836
Multicenter Study That Offers New Solutions for Paediatric Rehabilitation by Proposing a Rehabilitation Plan Based on Each Child's Needs Using New Technological and Robotic Devices, Combined Among Them.
NCT06666829
Analysis of the Psychometric Properties of Kinematic Parameters of Locomotion Measured by Inertial Measurement Units. Validation in Healthy Children and Children with Cerebral Palsy
NCT06138925
Functional Assessment Protocol for the Upper Limb for Pediatric Age
NCT06400667
Validation of a 3D Instrumented Serious Game to Evaluate Upper Limb Impairments in Children With Neuromotor Disorders
NCT06774456
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Neuromotor impaired
Inapplicable
Inapplicable
Control
Inapplicable
Inapplicable
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Inapplicable
Inapplicable
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
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
5 Years
17 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Politecnico di Milano
OTHER
IRCCS Eugenio Medea
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Scientific Institute IRCCS E.Medea
Bosisio Parini, LC, Italy
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RC 2024-2026 to E. Biffi
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
L2-246
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.