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 @ 7:57 PM
Ignite Modification Date:
2025-12-24 @ 7:57 PM
NCT ID:
NCT03296904
Eligibility Criteria:
Inclusion Criteria:
* Unilateral trans-femoral amputation (any cause)
* Completed the post amputation rehabilitation process
* Medicare Functional Classification Level ≤ K3
Exclusion Criteria:
* Poor cognitive skills (Mini Mental State Examination)
* Severe anxiety or depression (State-Trait Anxiety Inventory Form Y and Beck Depression Inventory II, respectively)
* Relevant comorbidity (hemiplegia, degenerative nervous system diseases, hip or knee replacement, chronic heart failure, chronic obstructive pulmonary disease, act.)
* Stump pain/socket poor fitting
* Implantable cardiac devices (PMK and AICD)
* Inability to walk on a treadmill
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
80 Years
Study:
NCT03296904
Study Brief:
Protocol Section:
NCT03296904