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 @ 2:26 AM
Ignite Modification Date:
2025-12-25 @ 2:26 AM
NCT ID:
NCT04695834
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent to participate in the study must be obtained from the subject or proxy / legal representative prior to initiation of any study-mandated procedure
* EDX-documented peroneal nerve entrapment with persisting (10 ± 4 weeks) foot drop (MRC-score ≤ 3)
* Imaging (ultrasound/MRI) performed to exclude a compressive mass
* Age ≥ 18 years
Exclusion Criteria:
* Subjects with posttraumatic or iatrogenic peroneal nerve injury
* Subjects with peroneal neuropathy due to a compressive mass (e.g. cyst, tumour)
* Peroneal nerve entrapment at other sites than the fibular head
* Patients with mental or physical problems that incapacitate them to participate in a physiotherapy program
* Psychiatric illness
* Pregnancy
* Planned (e)migration within 1 year after randomization to another country
* Subjects with previous foot drop
* Permanently bedridden subjects
* Subjects with neurological or musculoskeletal history which could impact foot drop assessment and/or gait analysis (e.g. polyneuropathy, hereditary neuropathy with pressure palsies, critical illness polyneuropathy, previous stroke, ankle surgery, …).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04695834
Study Brief:
Protocol Section:
NCT04695834