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NCT06073522Not yet recruiting

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

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

Source: ClinicalTrials.gov · Last updated 10 Oct 2023 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
500 (estimated)
First submitted
4 Oct 2023
Start date
10 Oct 2023
Primary completion date
30 Oct 2024
Lead sponsor
IRCCS Fondazione Stella Maris
Diseases
Stroke
NCT number
NCT06073522

What you commit to

  • Study type: Observational
  • Planned participants: 500
  • From 10 Oct 2023 to the primary completion date, 30 Oct 2024
  • 2 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

  • Children with confirmed diagnosis of UCP mainly spastic form
  • Ages from 5 to 15 years old
  • Manual ability levels from I to III in the Manual Ability Classification System (MACS) Exclusion criteria
  • Severe Upper Limb (UpL) impairment (MACS ≥ level IV: inability to grasp)
  • Botulinum toxin-A injections in UpL within 6 months prior to study entry
  • UpL surgery within 12 months prior to study entry
  • Severe comobordities and/or severe cognitive disability
    • For Typically developing children:
  • Ages from 5 to 15 years old
  • No documented clinically relevant disorders

Criteria the registry did not label

  • For the group of children with UCP:

Age in the registry: 5 years to 15 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Universidad de Castilla La Mancha
Coordinator of this site? Confirm its status
ToledoSpainUnknown status
IRCCS Fondazione Stella Maris
Coordinator of this site? Confirm its status
PisaItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.