Status:
RECRUITING
Study on a Prosthetic Foot With Adjustable Heel Height
Lead Sponsor:
Otto Bock France SNC
Conditions:
Lower Limb Amputation Above Knee
Lower Limb Amputation Below Knee
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Most prosthetic feet have a fixed heel height, which requires users to always wear shoes with the same heel height. A fixed heel height is a significant constraint, whereas the ability to choose one's...
Detailed Description
The amputation or absence of a lower limb affects both mobility and appearance, which can lead to restrictions in social, family, and professional participation. The choice of prosthetic components ai...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 6 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07214493
Start Date
October 8 2025
End Date
June 6 2026
Last Update
November 25 2025
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
CH Cornouaille
Concarneau, France
2
CHU Grenoble
Échirolles, France
3
IRR Louis Pierquin
Nancy, France
4
CRRF La Tourmaline
Saint-Herblain, France