Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-25 @ 1:46 AM
NCT ID:
NCT04088994
Eligibility Criteria:
Inclusion Criteria:
* confirmed diagnosis of UCP according to definition (MRI and clinical history)
* age 6-16 years at the time of recruitment;
* mild or moderate disability of the upper limb: score between 4 and 7 according to the House Functional Classification (HFC) system;
* sufficient cooperation and understanding to participate in the activities, according to the doctor/physiotherapist who is treating the child and to the neuropsychological evaluation.
Exclusion Criteria:
* cognitive, visual or auditory impairments;
* history of seizures or seizures not well controlled by therapy;
* upper limb surgery within 8 months prior to enrollment;
* upper limb botulinum toxin injection (BoNT-A) within 6 months prior to enrollment.
Additional exclusion criteria for participants in fMRI sessions:
* insufficient cooperation to participation in neuroimaging studies lasting about 30 minutes;
* presence of contraindications to instrumental investigations using 3 Tesla Magnetic Resonance system (implants, metal prostheses, shunts etc.). The presence of these contraindications will be verified by the use of a preliminary questionnaire administered to the parents.
* \< 9 years at the time of recruitment.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
16 Years
Study:
NCT04088994
Study Brief:
Protocol Section:
NCT04088994