Clinical Trial

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

Study acronym: AInCP
Not Yet Recruiting
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Record status
This record was last updated October 10, 2023 (before its estimated October 30, 2024 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2023-10-04.
Trial Details
NCT Number NCT06073522
Lead Sponsor IRCCS Fondazione Stella Maris
Collaborators: University of Pisa, University of Castilla-La Mancha, Fight The Stroke, SCUOLA SUPERIORE DI STUDI UNIVERSITARI E DI PERFEZIONAMENTO S ANNA, Noldus Information Technology Bv, Khymeia, Tyromotion GMBH, The University of Queensland, University of Salento
Conditions Unilateral Cerebral Palsy
Enrollment 500 participants
Start Date 2023-10-10
Primary Completion 2024-10-30 (estimated)
Study Completion 2027-06-30 (estimated)
Updated on ClinicalTrials.gov 2023-10-10