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 @ 3:43 PM
Ignite Modification Date:
2025-12-24 @ 3:43 PM
NCT ID:
NCT01473992
Eligibility Criteria:
Inclusion criteria:
* Unilateral transfemoral or knee-disarticulation amputee
* 18 to 85 years of age
* K3 (variable cadence and community) ambulators;
* Current use of and experience with the C-Leg for at least 1 year
* Ability to descend stairs and hills without caregiver and assistive devices
* Be able to independently provide informed consent
* Be willing to comply with study procedures.
Exclusion criteria:
* History of chronic skin breakdown on the residual limb
* Conditions that would prevent participation and pose increased risk (e.g. unstable cardiovascular conditions that preclude physical activity such as walking)
* Use of any assistive devices/walking aids, beyond a prosthesis, to ambulate
* Unwillingness/inability to follow instructions
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT01473992
Study Brief:
Protocol Section:
NCT01473992