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 @ 7:34 PM
Ignite Modification Date:
2025-12-24 @ 7:34 PM
NCT ID:
NCT07085403
Eligibility Criteria:
Inclusion criteria:
* Children/adolescents (8-16 years old) with coordination disorders and/or executive function deficits, following a acquired brain injury more than 3 months ago or a congenital brain lesion or a neurodevelopmental disorder.
* Executive function deficits as assessed by neuropsychological tests (standardised tests and/or questionnaires) and/or coordination disorders as assessed by neuropsychological tests (standardised tests and/or questionnaires).
* Vision and hearing normal or sufficient to communicate effectively (with appropriate correction where necessary).
* Cognitive, behavioural and expressive/receptive communication skills enabling them to identify goals and participate actively in the CO-OP intervention process.
* Membership of a health insurance scheme or beneficiary.
* Agreement of the child/adolescent and informed consent expressed by at least one of the holders of parental authority.
Non-inclusion criteria :
* Children/adolescents who do not meet the inclusion criteria.
* Children/adolescents and/or parents non-French-speaking.
* Presenting intellectual difficulties, or severe problems of comprehension, memory or attention, as described in the CO-OP recommendations.
* A diagnosed severe anxiety-depressive disorder that is not compatible with participation in the study.
* Inability to remain involved until the end of the CO-OP intervention phase (e.g. planned move).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
16 Years
Study:
NCT07085403
Study Brief:
Protocol Section:
NCT07085403