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 @ 5:55 PM
Ignite Modification Date:
2025-12-24 @ 5:55 PM
NCT ID:
NCT06044168
Eligibility Criteria:
Inclusion Criteria:
Spastic Cerebral Palsy (diagnosed by a neuro-pediatrician from the CP Reference Centre of the University Hospital Leuven)
* Uni- of bilateral involvement
* Level II or III on the Gross Motor Function Classification System (GMFCS)
* Muscle volume for the medial gastrocnemius (target muscle) of at least 20% compared to the expected muscle volume in age-matched typically developing children
Exclusion Criteria:
* Presence of dyskinesia or ataxia
* Severe co-morbidities
* Botulinum toxin treatment ten months prior to assessment
* Previous orthopedic or neurosurgery
* Severe ankle deformities preventing fitting in test positions
* Ankle range of motion (ROM) \<30% of normal values
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
10 Years
Study:
NCT06044168
Study Brief:
Protocol Section:
NCT06044168