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 @ 9:42 PM
Ignite Modification Date:
2025-12-24 @ 9:42 PM
NCT ID:
NCT03440632
Eligibility Criteria:
Inclusion Criteria:
* Unilateral foot drop of central origin, particularly the absence of initial heel contact
* Participants are currently treated with ankle-foot orthoses or (adapted) shoes to wear on a daily basis
* Participants ambulate independently, and thus classified as Gross Motor Function Classification System (GMFCS) levels I or II and have a gait type 1 according to Winters et al (4).
* Participants are able to walk for at least 15 minutes
* Confirmed cerebral abnormality with MRI (showing medial infarction, maldevelopment of the brain, or porencephaly).
* Participants are aged 4-18 years at time of inclusion
Exclusion Criteria:
* Plantarflexion ankle contracture of more than 5 degrees plantarflexion with the knee extended
* Botulinum toxin A injection to the plantar or dorsiflexor muscle groups within the 6 months before the study
* Orthopaedic surgery to the legs in the previous year
* Uncontrolled epilepsy with daily seizures
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
18 Years
Study:
NCT03440632
Study Brief:
Protocol Section:
NCT03440632