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 @ 1:05 AM
Ignite Modification Date:
2025-12-25 @ 1:05 AM
NCT ID:
NCT07301593
Eligibility Criteria:
Inclusion Criteria:
* Children from 8 to 15 years old
* Spastic, hemiparetic cerebral palsy
* Level I or II on the Gross Motor Function Classification System
* Ability to walk and run 10 meters without assistance
* Ability to jump (simultaneous lift of both feet)
* Daily use of a plastic ankle foot orthosis allowing ankle mobility
* Affiliated to a social security scheme
Exclusion Criteria:
* Children with ataxic, dyskinetic, or mixed-type cerebral palsy
* Children with cognitive, intellectual, or behavioral disorders that may impair their understanding of instructions, the proper conduct of evaluations, or the use of assessment scales, as judged by the investigator.
* Children who have received botulinum toxin injections within 4 months prior to the inclusion visit
* Children or adolescents who have undergone surgical intervention:
within the past 6 months prior to inclusion if no bony procedure was performed, or within the past 12 months prior to inclusion if a bony procedure was performed, or who have a planned surgical procedure during the study period.
* Children who have participated in an intensive rehabilitation program within 4 months prior to the inclusion visit
* Children or adolescents participating in another interventional study that could interfere with the outcomes of the present study by altering the subject's physical abilities.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
15 Years
Study:
NCT07301593
Study Brief:
Protocol Section:
NCT07301593