Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT06073522

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

Sponsor: IRCCS Fondazione Stella Maris

View on ClinicalTrials.gov

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.

Official title: Clinical Validation of Artificial INtelligence for Providing a Personalized Motor Clinical Profile Assessment and Rehabilitation of Upper Limb in Children With Unilateral Cerebral Palsy

Key Details

Gender

All

Age Range

5 Years - 15 Years

Study Type

OBSERVATIONAL

Enrollment

500

Start Date

2023-10-10

Completion Date

2027-06-30

Last Updated

2023-10-10

Healthy Volunteers

Yes

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 )

Locations (2)

IRCCS Fondazione Stella Maris

Pisa, Italy

Universidad de Castilla - La Mancha

Toledo, Spain