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 @ 2:44 AM
Ignite Modification Date:
2025-12-25 @ 2:44 AM
NCT ID:
NCT06390033
Eligibility Criteria:
Inclusion Criteria:
* unilateral transtibial amputees,
* with more than 12 months of experience using a prosthesis,
* with a K2 prosthesis or above,
* be able to walk continuously unaided with the prosthetic foot for at least 20 minutes.
Exclusion Criteria:
* with a short or an injured residual limb,
* pregnant,
* any neurological or musculoskeletal diseases,
* have a record of active endocarditis and acute myocarditis/pericarditis,
* experience ongoing unstable angina,
* have uncontrolled cardiac arrhythmia with hemodynamic compromise,
* have had a recent stroke or transient ischemic attack,
* have high blood pressure, etc.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
36 Years
Maximum Age:
64 Years
Study:
NCT06390033
Study Brief:
Protocol Section:
NCT06390033