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 @ 4:23 AM
Ignite Modification Date:
2025-12-25 @ 4:23 AM
NCT ID:
NCT06419920
Eligibility Criteria:
Inclusion Criteria:
* lower limb amputation at ankle (Symes) level and above
* age 18+ years
* fitted with a walking prosthesis and use it regularly for home and/or community ambulation
* good socket fit, assessed by a score of 8-10 on the socket fit comfort scale
* able to walk for three minutes at a time with or without an assistive device
Exclusion Criteria:
* leg/foot ulcer or other conditions that cause pain during weight-bearing
* poor skin integrity that could cause tissue breakdown by walking
* cardiovascular, respiratory or other critical health conditions that preclude moderate physical activity
* unilateral or bilateral upper limb absence or loss at the wrist and above that precludes use of handrails bilaterally, or would require asymmetrical adaptation to body posture for use.
* pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06419920
Study Brief:
Protocol Section:
NCT06419920