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 @ 4:57 PM
Ignite Modification Date:
2025-12-24 @ 4:57 PM
NCT ID:
NCT05412550
Eligibility Criteria:
Inclusion Criteria:
* Unilateral or bilateral lower-limb amputation (transmetatarsal to him disarticulation, traumatic or non-traumatic etiology)
* Ability to walk two minutes without seated rest using prosthesis and assistive device if needed
* Living without assistance for basic activities of daily living
Exclusion Criteria:
* Congenital or cancer-related amputation
* Unstable heart condition including:
* unstable angina
* uncontrolled cardiac dysrhythmia
* acute myocarditis
* acute pericarditis
* Acute systemic infection
* Prisoner
* Mild cognitive impairment
* Active cancer treatment
* Discretion of PI to exclude patients who are determined to be unsafe and/or inappropriate to participate
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
89 Years
Study:
NCT05412550
Study Brief:
Protocol Section:
NCT05412550