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:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-24 @ 11:58 PM
NCT ID:
NCT04280458
Eligibility Criteria:
Inclusion Criteria:
* Children between 4 and 13 years;
* With polyhandicap defined by association of the 5 following criteria:
* Causal brain injury occurred before the age of 3 years
* Severe or deep mental deficiency as defined by IQ \< 40, or no evaluable by the psychometric tests
* Motor impairment: para / tetraparesis, hemiparesis, ataxia, or extrapyramidal motor disorders
* Score of Gross Motor Function Classification System \[Palisano 1997\] is III, IV or V
* Score of Functional Independence Measure \< 50;
* Hospitalization in a clinical setting participating to the study;
* Beneficiary of a social protection;
* Written consent signed by personnel holding parental authority or legal representative.
Exclusion Criteria:
* Patient with progressive encephalopathies including metabolic origin, epileptic, or neurodegenerative diseases;
* Planned to move in another clinical setting;
* Foreseeable difficulty in the following up in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
13 Years
Study:
NCT04280458
Study Brief:
Protocol Section:
NCT04280458