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:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07385859
Eligibility Criteria:
Inclusion Criteria:
* Adults aged 18 to 64 years
* Unilateral transtibial lower limb amputation
* Use of a prosthesis for at least one year
* Ability to ambulate independently with a prosthesis
* Ability to read and understand questionnaires
* Voluntary participation with written informed consent
Exclusion Criteria:
* Congenital limb deficiency
* Bilateral lower limb amputation
* Neurological disorders affecting mobility (e.g., stroke, Parkinson's disease)
* Severe musculoskeletal conditions influencing gait or balance
* Recent prosthetic replacement within the previous six months
* Severe residual limb pain or uncontrolled phantom limb pain
* Cognitive or psychiatric impairment that could interfere with questionnaire completion
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT07385859
Study Brief:
Protocol Section:
NCT07385859