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:
NCT04328168
Eligibility Criteria:
Inclusion Criteria:
* Aged 4\>, \<16 with CP diagnosis
* Walking diffculties due to the spasticity of lower extremities,
* Level I-IV on the Gross Motor Function Classification System.
Exclusion Criteria:
* MAS Level IV spasticity, contractures, or rigidity in the lower extremities,
* A limb length inequality of \>2 cm,
* Hypotonic CP,
* Having drug-related refractory epilepsy,
* Undergoing intrathecal baclofen pump surgery,
* Surgical interventions in the lower extremities in the last year,
* Scoliosis angle of \>30°,
* Complicated osteoporosis (nontraumatic fracture...),
* Cardiovascular instability,
* GMFCS Level V,
* Metabolic disorder, genetic disease, neurodegenerative and neuromuscular diseases.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
10 Years
Study:
NCT04328168
Study Brief:
Protocol Section:
NCT04328168