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Neuromotor ImpairmentsAI-REMAPNCT07664033

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

A study testing Artificial Intelligence Model for Rehabilitation Engagement Monitoring in people with Neuromotor Impairments, run by IRCCS Eugenio Medea at 1 site in Italy.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 5 to 17 years
Conditions the study is for
Neuromotor Impairments
What is being tested?
Artificial Intelligence Model for Rehabilitation Engagement Monitoring
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteItaly
Study dates
15 Jun 2026to 30 Sep 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • Uncooperative subjects.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Fabio Alexander Storm, PhD contact

+39 031877111

fabio.storm@lanostrafamiglia.it

Simone Costantini, MSc contact

simone.costantini@lanostrafamiglia.it

Italy1 site

  • Scientific Institute IRCCS E.Medea

    Bosisio Parini, 23842

    Fabio Alexander Storm, PhD, +39 031877111, fabio.storm@lanostrafamiglia.it

    Emilia Biffi, PhD, +39 031877111, emilia.biffi@lanostrafamiglia.it

Other trials in Italy

About this study

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

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.

Read more

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.

Being tested
Artificial Intelligence Model for Rehabilitation Engagement Monitoring
Keywords
Engagement, Pediatric Rehabilitation, Neuromotor Impairments, Gait, Heart Rate Variability, Electrodermal Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Artificial Intelligence Model for Rehabilitation Engagement MonitoringDevice

    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 groups in NCT07664033
Study groupRoleWhat they receive
Real-Time Engagement MonitoringExperimentalParticipants 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.
Receives: Device: Artificial Intelligence Model for Rehabilitation Engagement Monitoring

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline

Secondary outcomes (2)

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

    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.

    Measured: Baseline

  2. AI Model-Inferred Engagement Level

    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).

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2026
  2. Study start15 Jun 2026 (estimated)
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion30 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07664033
Sponsor's protocol ID
L2-246-F2
Other IDs
RC 2024-2026 to E. Biffi
Acronym
AI-REMAP
Status last verified
Jun 2026
First submitted
8 Jun 2026
Last updated
23 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The results obtained at the end of this clinical trial will be presented at national and international conferences and submitted to peer-reviewed international journals. The raw data of the study will be published among the supplementary materials of scientific articles and/or uploaded to Zenodo, a multidisciplinary repository, managed by CERN in Geneva, which allows researchers to share and preserve research results in any size and form. Depositing data in ZENODO guarantees their compliance with the FAIR principles.

Publications

  • 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.

    PubMed 31163093

  • 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.

    PubMed 31700676

  • 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.

    PubMed 29149163

  • 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.

    PubMed 21674389

  • 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.

    PubMed 39702317

Questions about this trial

What is this clinical trial studying?

A study testing Artificial Intelligence Model for Rehabilitation Engagement Monitoring in people with Neuromotor Impairments, run by IRCCS Eugenio Medea at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Fabio Alexander Storm, PhD (+39 031877111, fabio.storm@lanostrafamiglia.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

System Usability Scale (SUS) Score (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07664033, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.

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