Clinical Validation of Artificial INtelligence for Providing a Personalized Motor Clinical Profile Assessment and Rehabilitation of Upper Limb in Children With Unilateral Cerebral Palsy
Trial ID: NCT06073522
Status: NOT_YET_RECRUITING
Study type: OBSERVATIONAL
Start date: 2023-10-10
Completion date: 2027-06-30
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
Interventions: Artificial Intelligence for combining multi-domain data acquisition
Locations: IRCCS Fondazione Stella Maris; Universidad de Castilla - La Mancha
Countries: Italy; Spain
Enrollment: 500
Age range: 5 Years - 15 Years
Sex: ALL

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.

Eligibility criteria:
For the group of children with UCP:

Inclusion criteria

* 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

Outcomes:
score of modified Ashworth Scale (MAS); score of grip strenght by means of Jamar dynamometer Grip strength will be assessed with the Jamar dynamometer; score of mirror movements; score of Stereognosis (tactile object identification); score of Two point discrimination test; score of Assisting Hand Assessment; score of the Melbourne Assessment 2; score of the Box and block test; score of NEuroPSYchological assessment (NEPSY-II); score of Leiter International Performance Scale (Leiter-III); score of Developmental Test of Visual-Motor Integration (VMI); score of MOXO-continuous performance test; score of Corsi block-tapping test; score of Behaviour Rating Inventory of Executive Function (BRIEF-P/2) for parents; score of Child Behavior Checklist (CBCL); score of Wechsler Preschool and Primary Scale of Intelligence (WPPSI-IV) for children aged 2,64 - 7,7 years; 3.9. Wechsler Intelligence Scale for Children (WISC) for children ages 6 - 16 years; score of Test of Visual Perceptual Skills (TVPS-4); level of Manual Ability Classification System (MACS); level of House Functional Classification System (HFCS); level of Bimanual Fine Motor Function version 2 (BFMF 2); score of ABILHAND-Kids questionnaire; score of Children's Hand-use Experience Questionnaire (CHEQ); score of Participation and Environmental Measure for Children and Youth (PEM-CY); score of Cerebral Palsy Quality of Life Questionnaire for parents (4-18, with the two version for parents of children aged 4-12 or of teen 13-17) and teenagers (12-18) (CP-QOL); Edinburgh Handedness Inventory (EHI) questionnaire (for children with TD); score of Developmental Coordination Disorder Questionnaire (DCDQ) (for children with TD); score in personalized surveys for children, parents and healthcare professionals; score of neuroimaging; score of upper limb movement analysis during clinical assessment and daily life