Status:
NOT_YET_RECRUITING
Validation of AI for Personalized Assessment and Rehabilitation of Upper Limb in Children With Unilateral Cerebral Palsy
Lead Sponsor:
IRCCS Fondazione Stella Maris
Collaborating Sponsors:
University of Pisa
University of Castilla-La Mancha
Conditions:
Unilateral Cerebral Palsy
Eligibility:
All Genders
5-15 years
Brief 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 eviden...
Detailed Description
The project is configured as an international observational clinical non-profit study that aims to change the current management of care and intervention of children and adolescents with UCP, providin...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 10 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06073522
Start Date
October 10 2023
End Date
June 30 2027
Last Update
October 10 2023
Active Locations (2)
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1
IRCCS Fondazione Stella Maris
Pisa, Italy, 56128
2
Universidad de Castilla - La Mancha
Toledo, Spain, 45071