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 @ 2:23 AM
Ignite Modification Date:
2025-12-25 @ 2:23 AM
NCT ID:
NCT03333434
Eligibility Criteria:
Inclusion Criteria:
* \- Clinical indication to the use of orthoses to improve the walking function confirmed by instrumental parameters obtained from analysis of the path (dynamic electromyography, optoelectronic stereophotogrammetry analysis);
* Patients who already have AFO orthoses (or ankle-7) that need to be renewed;
* Patients with new clinical indication to the use of orthoses but not yet in possession of the same;
* Informed consent from parents / guardians of the child
Exclusion Criteria:
* Cognitive disabilities that may affect the child's participation in the activities related to this study, in the opinion of the investigators;
* Lower limbs sensory disability that may affect any beneficial effects of the use of the orthoses, in the opinion of the investigators;
* Other diseases associated or not associated with PCI that, according to investigators, could affect the child's participation in the activities related to this study (eg: drug-resistant epilepsy);
* Administration of antispasmodic drugs in the last 6 months;
* Functional surgery of the lower limbs in the last 6 months;
* Indication for surgical treatment to be carried out within 6 months after the date of inclusion in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
18 Years
Study:
NCT03333434
Study Brief:
Protocol Section:
NCT03333434