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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age5-15
SponsorIRCCS Fondazione Stella Maris

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Artificial Intelligence for combining multi-domain data acquisition

Treatment groups

500 Participants
are divided into 2 treatment groups

Sponsors and collaborators

IRCCS Fondazione Stella Maris

Lead sponsor

University of Pisa

Collaborator

University of Castilla-La Mancha

Collaborator

Fight The Stroke

Collaborator

SCUOLA SUPERIORE DI STUDI UNIVERSITARI E DI PERFEZIONAMENTO S ANNA

Collaborator

Noldus Information Technology Bv

Collaborator

Khymeia

Collaborator

Tyromotion GMBH

Collaborator

The University of Queensland

Collaborator

University of Salento

Collaborator