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 @ 7:21 PM
Ignite Modification Date:
2025-12-24 @ 7:21 PM
NCT ID:
NCT05884203
Eligibility Criteria:
Inclusion Criteria:
* Unilateral transtibial amputation
* Been fit with a prosthesis and used it for at least 6 months
* Wear the prosthesis for 4 or more hours on average per day
* Has a prosthesis that bolts to the bottom of the socket
* Be at least one-year post-amputation
* Able to walk on a treadmill
* Have an eligible and available study helper
Exclusion Criteria:
* Improper fit and suspension with current prosthesis and one cannot be achieved with clinical resources
* Current skin irritation or injury on residual limb
* Osteoarthritis, injury, or pain that interferes with walking ability
* Currently incarcerated
* Pregnant
* Inadequate cognitive function or language proficiency to consent to participate
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05884203
Study Brief:
Protocol Section:
NCT05884203