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 @ 11:52 AM
Ignite Modification Date:
2025-12-24 @ 11:52 AM
NCT ID:
NCT06161961
Eligibility Criteria:
Inclusion Criteria:
* Trans-tibial lower limb amputation;
* Medicare functional classification: Level K3-K4;
* Subjects who have worn prostheses for at least 1 year (experienced wearers);
* Use of prosthesis with energy-returning prosthetic foot.
Exclusion Criteria:
* Relevant medical comorbidities (serious neurological pathologies, cardiovascular pathologies, diabetes/hypertension not stabilized, severe sensory deficits);
* Wearers of implantable cardiac medical devices (PMK or AICD);
* Cognitive impairment (MMSE corrected for age and education \<24);
* Inability or unavailability to provide informed consent;
* Severe depressive and/or anxious symptoms.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06161961
Study Brief:
Protocol Section:
NCT06161961