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 @ 12:35 PM
Ignite Modification Date:
2025-12-24 @ 12:35 PM
NCT ID:
NCT05560061
Eligibility Criteria:
Inclusion Criteria:
* lower limb amputation at ankle level or above
* properly fitted with a walking prosthesis, used regularly for home and/or community ambulation
* good socket fit assessed by a score of 7-10 on the socket fit comfort score (Hanspal et at., 2003).
* able to walk for two minutes at a time with or without an assistive device
* willing to travel to the test site two times for training and testing.
Exclusion Criteria:
* leg/foot ulcer/sore or other conditions that cause pain during weight-bearing
* 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
* diagnosis of cognitive disturbances
* allergy to medical adhesives
* women who are pregnant or think they may be pregnant
* acute illness
* dizziness on the day of testing
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05560061
Study Brief:
Protocol Section:
NCT05560061