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 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT04709367
Eligibility Criteria:
Inclusion Criteria:
* Stabilized (i.e., time since amputation \> 18 months) transfemoral amputees
* Age between 18 and 65 years old
* Subjects able to safely perform the physical tasks required in the experimental protocol
* Subjects provided with prostheses
Exclusion Criteria:
* Denial of informed consent to participate in the study
* Inability to maintain the required position during the 3D scanning for at least 5 minutes
* Concomitant general or localized comorbidities / disabilities, which may interfere with the study
* Pathological conditions affecting the residual limb
* Allergy / sensitivity with polydimethylsiloxane (PDMS)
* Pathological cardiopulmonary / cardiovascular conditions
* Pregnancy or breastfeeding
* Presence of psychiatric co-morbidities
* Presence of cognitive deficits which may compromise the understanding of the required tasks
* Difficulty in understanding the Italian language
* Insufficient degree of collaboration
* Consumption of alcohol or diuretics before tests
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04709367
Study Brief:
Protocol Section:
NCT04709367