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 @ 12:58 AM
Ignite Modification Date:
2025-12-25 @ 12:58 AM
NCT ID:
NCT07214493
Eligibility Criteria:
Inclusion Criteria :
* Adult patient with a major lower limb amputation whose life project includes:
* movement in buildings other than the home (ICF d4601),
* movement outside the home and other buildings (ICF d4602),
* and other specified activities related to movement in other various places (ICF d4608).
* Patient who has been using an Enregy storage and Return (ESR) foot for at least 3 months
* Patient who wishes to walk with shoes with different heel heights, and/or barefoot
Exclusion Criteria:
* Patient with a high impact level (e.g.: sport)
* Patient with hip disarticulation or equivalent
* Patient with an unstabilised residual limb and/or an unsuitable socket
* Patient who cannot be fitted with a Taleo Adjust foot due to the technical characteristics of the product (user weight greater than 115kg; required foot size \<22 or \>28; mounting height less than 118 mm)
* Patient whose usual foot has a heel height adjustment system
* Patient unavailable for the duration of the study and/or unable to understand the instructions and/or answer questionnaires in French
* Patient already participating in another study
* Patient in an emergency situation or pregnant woman
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07214493
Study Brief:
Protocol Section:
NCT07214493