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Search / Trial NCT06073522

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

Launched by IRCCS FONDAZIONE STELLA MARIS · Oct 4, 2023

Trial Information

Current as of August 27, 2025

Not yet recruiting

Keywords

Cerebral Palsy Paediatric Stroke Predictive Biomarkers Brain Structure Upper Limb Assessment Upper Limb Rehabilitation Machine Learning Data Science Telerehabilitation Multi Agent Systems Intelligent Systems Artificial Intelligence

ClinConnect Summary

This clinical trial, called AInCP, is focused on improving how we assess and treat children with unilateral cerebral palsy (UCP), which is a common condition that affects movement, especially in one arm. The goal of the trial is to create personalized tools that can help doctors understand each child's specific needs and provide tailored rehabilitation plans that can even be done at home. The researchers will use advanced technology, including artificial intelligence, to gather information about the children's abilities and how they respond to treatment. This study aims to involve over 300 children in total, including those with UCP as well as typically developing children for comparison.

To be part of this trial, children with UCP need to be between 5 and 15 years old and have a confirmed diagnosis of the condition, specifically the spastic type, which affects their ability to move. However, children with severe movement issues or other significant health problems won't be included. Participants can expect to take part in assessments and possibly receive personalized treatment plans based on their unique strengths and challenges. This trial is not yet recruiting, but it promises to pave the way for better, more effective rehabilitation for children with UCP.

Gender

ALL

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

About Irccs Fondazione Stella Maris

IRCCS Fondazione Stella Maris is a leading Italian research institute dedicated to advancing the field of child and adolescent neuropsychiatry. As an IRCCS (Istituto di Ricovero e Cura a Carattere Scientifico), it is recognized for its commitment to integrating clinical care with cutting-edge scientific research. The foundation focuses on understanding and treating various neurodevelopmental disorders through innovative clinical trials, multidisciplinary collaboration, and a patient-centered approach. With a mission to improve the mental health and well-being of young patients, IRCCS Fondazione Stella Maris plays a pivotal role in shaping the future of pediatric psychiatry in Italy and beyond.

Locations

Pisa, , Italy

Toledo, , Spain

Patients applied

0 patients applied

Trial Officials

Giuseppina Sgandurra, Md, PhD

Principal Investigator

IRCCS Fondazione Stella Maris

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported