Validation of AI for Personalized Assessment and Rehabilitation of Upper Limb in Children With Unilateral Cerebral Palsy

NCT06073522 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2023-10-10

No results posted yet for this study

Summary

Unilateral Cerebral palsy (UCP) is the most common neurological chronic disease in childhood with a significant burden on children, their families and health care system.

AInCP aims to develop evidence-based clinical Decision Support Tools (DST) for personalized functional diagnosis, Upper Limb (UpL) assessment and home-based intervention for children with UCP, by developing, testing and validating trustworthy Artificial Intelligence (AI) and cost-effective strategies. The AInCP approach will: i) establish a clinical diagnosis and accurate prognosis for treatment response of individual UCP profiles, by employing a multimodal approach including clinical phenotyping, advanced brain imaging and real-life monitoring of UpL function, and ii) provide personalized home-based treatment, from advanced ICT and AI technologies.

The AInCP will build upon personalized diagnostic and rehabilitative DST (dDST and rDST) to be developed and validated through large observational and rehabilitation studies, including at least 200 and 150 children with UCP, respectively. Using data driven and AI approach, dDST and rDST will be combined for developing a theranostic DST (tDST) that will allow the re-designing of an economical, ethical, sustainable decision-making process for delivering a personalized and validated approach, focused on the care, monitoring and rehabilitation of UpL in children with UCP. AInCP is a significant example of a transdisciplinary approach, where all project collaborators (clinicians, data scientists, physicists, engineers, economists, ethicists, SMEs, children and parent associations) will work closely together in building the AInCP approach. This approach will, therefore, hinge on transdisciplinary contributions, multi- dimensional data, sets of innovative devices and fair AI-based algorithms, clinically effective and able to reduce users? and market barriers of acceptability, reimbursability and adoption of the proposed solution.

Conditions

  • Unilateral Cerebral Palsy

Interventions

OTHER

Artificial Intelligence for combining multi-domain data acquisition

Artificial Intelligence and machine learning techniques to combine data coming from multidomains data collection (such as clinical multiaxial assessments and questionnaires, Neuroimaging, Upper limb movement analysis during clinical assessment and daily life )

Sponsors & Collaborators

  • University of Pisa

    collaborator OTHER
  • University of Castilla-La Mancha

    collaborator OTHER
  • Fight The Stroke

    collaborator UNKNOWN
  • SCUOLA SUPERIORE DI STUDI UNIVERSITARI E DI PERFEZIONAMENTO S ANNA

    collaborator OTHER
  • Noldus Information Technology Bv

    collaborator UNKNOWN
  • Khymeia

    collaborator UNKNOWN
  • Tyromotion GMBH

    collaborator UNKNOWN
  • The University of Queensland

    collaborator OTHER
  • University of Salento

    collaborator OTHER
  • IRCCS Fondazione Stella Maris

    lead OTHER

Principal Investigators

  • Giuseppina Sgandurra, Md, PhD · IRCCS Fondazione Stella Maris

Eligibility

Min Age
5 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-10
Primary Completion
2024-10-30
Completion
2027-06-30

Countries

  • Italy
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06073522 on ClinicalTrials.gov