RecruitingNot ApplicableNCT07214493

Study on a Prosthetic Foot With Adjustable Heel Height

Impact of a Prosthetic Foot With Adjustable Heel Height on Physical Appearance and Participation: a Randomized Crossover Trial.

Sponsor

Otto Bock France SNC

Enrollment

30 participants

Start Date

Oct 8, 2025

Study Type

INTERVENTIONAL

Conditions

Lower Limb Amputation Below Knee Lower Limb Amputation Above Knee

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 clothing freely is an important aspect of coping with a physical disability. The Taleo Adjust is a prosthetic foot with a hydraulic ankle that allows the user to adjust the heel height from 0 to 7 cm, depending on the type of shoe worn. This study aims to evaluate the impact of an adjustable-heel-height foot on physical appearance and participation.

Eligibility

Min Age: 18 Years

Inclusion Criteria6

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 Criteria8

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

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Interventions

DEVICETaleo Adjust

The Taleo Adjust foot is an energy-storage-and-return (ESR) prosthetic foot with a hydraulic ankle joint that allows an adjustable heel height from 0 to 7 cm.

DEVICEThe usual participant's foot

The usual foot of the participant is an Energy Storage and Return (ESR) prosthetic foot (no heel height adjustement)