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

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

Plain Language Summary

Simplified for easier understanding

This study is evaluating the Taleo Adjust — a prosthetic foot with a hydraulic ankle that allows users to change their heel height from flat to 7 cm — to see whether having an adjustable heel height improves how amputees feel about their physical appearance and participation in social, work, and daily activities. Most prosthetic feet have a fixed heel height, which limits shoe choices and daily flexibility for people with lower limb amputations. Adult lower limb amputees who have been using an energy-storing prosthetic foot for at least 3 months and want to walk in shoes of different heights or barefoot are eligible, while those with high activity levels like sport, unsuitable socket fit, or significant weight (over 115 kg) are excluded. Participants will be fitted with the Taleo Adjust foot and followed over the study period with questionnaires and assessments about appearance satisfaction and life participation. This summary was prepared to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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)


Locations(5)

CH Cornouaille

Concarneau, France

CHU Grenoble

Échirolles, France

IRR Louis Pierquin

Nancy, France

CRRF La Tourmaline

Saint-Herblain, France

Institut Merle d'Aubigné

Valenton, France

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NCT07214493


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