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 @ 1:06 PM
Ignite Modification Date:
2025-12-24 @ 1:06 PM
NCT ID:
NCT04725461
Eligibility Criteria:
Inclusion Criteria:
* Unilateral transtibial amputees having had their amputation at least 6 months prior, so that they have a relatively stable conical residual limb shape and can ambulate independently
* Currently has a well-fitting prosthesis- as defined by a self-reported Socket Comfort Score of at least a 6 out of 10
* K2, K3, K4 level ambulators
* Understands the English language
Exclusion Criteria:
* Cognitive impairment sufficient to adversely affect understanding of or compliance with study requirements, ability to communicate experiences, or ability to give informed consent: The ability to understand and comply with requirements of the study is essential in order for the study to generate usable, reliable data. The ability to obtain relevant user feedback and informal discussion adds significant value to this study.
* Significant other comorbidity: Any other medical issues or injuries that would preclude completion of the study (e.g stroke, pacemaker placement, etc), or that would otherwise prevent acquisition of usable data by researchers.
* Bulbous residual limb shape causing inability to fit within system restrictions
* Open wounds on the residual limb
* Inability to understand the English language
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
95 Years
Study:
NCT04725461
Study Brief:
Protocol Section:
NCT04725461