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Clinical Trials in France / NCT07214493
Recruiting Not applicable

Study on a Prosthetic Foot With Adjustable Heel Height

NCT07214493 · tracked via the Priya Life Science France tracker
Sponsor
Otto Bock France SNC
Phase
Not applicable
Started
2025-10-08
Last updated
2025-11-25

Condition(s) studied

Lower Limb Amputation Above KneeLower Limb Amputation Below Knee

Investigational drug(s) / intervention(s)

Taleo AdjustThe usual participant's foot

Taleo 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.

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

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Prosthetic Evaluation Questionnaire - Appearance scale (PEQ-AP) — 30 days
    A 5-item self-reported measure of the appearance domain. The participant rates each item by marking a 100-mm line. Scores range from 0 to 100, with higher scores indicating a more positive perception.

Trial sites (5)

FacilityCityRegionStatus
CH Cornouaille Concarneau France Recruiting
CHU Grenoble Échirolles France Recruiting
IRR Louis Pierquin Nancy France Recruiting
CRRF La Tourmaline Saint-Herblain France Recruiting
Institut Merle d'Aubigné Valenton France Recruiting

More Otto Bock France SNC trials in France

EXOPULSE Suit and Walking Ability of Patients With Multiple Sclerosis Recruiting

Other trials for the same condition

Clinical Evaluation of the Access Socket Flexible Socket for Transtibial Prosthesis Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07214493 on ClinicalTrials.gov ↗ ← All trials in France