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 @ 7:32 PM
Ignite Modification Date:
2025-12-24 @ 7:32 PM
NCT ID:
NCT05265403
Eligibility Criteria:
Inclusion Criteria:
* Unilateral transtibial amputation
* Aged between 18-65 years
* Body mass index between 18.5-29.9 (healthy weight)
* Daily use of their clinically-prescribed prosthesis for ambulation without an assistive device
* Classified as at least a Medicare Functional Classification Level K3 (defined as a patient who is a typical unlimited community ambulator)
* Experience walking with a prosthesis for at least one year
* Residuum and amputated side in good condition (e.g., no adherent scars, lesions, ulcers, or infections)
* Normal or corrected vision
* Ability to walk continuously for 45 minutes without undue fatigue or health risks.
Exclusion Criteria:
* Subjects who weigh more than 200 pounds
* Poor fitting prosthetic socket
* Skin problems on the residual limb
* Co-morbidities or pathologies (other than the amputation) or medications that would affect the sound limb, spine, balance, or stability
* Decision by prosthetists at Hanger that walking on the prototype limb may pose higher than minimal risk for a potential subject.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05265403
Study Brief:
Protocol Section:
NCT05265403