Taleo Adjust prosthetic foot with adjustable heel height

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The Taleo Adjust is an energy-storing and energy-returning prosthetic foot with a hydraulic ankle that lets users change heel height from 0 to 7 cm while preserving prosthetic alignment. Adult participants with above- or below-knee amputations who have used an ESR (energy storage and return) foot for at least three months will try the Taleo Adjust in place of their usual foot. The study measures effects on perceived physical appearance and participation with in-person fittings and follow-up at participating centers. Key exclusions include hip disarticulation, high-impact users, unstable residual limb or unsuitable socket, weight over 115 kg, incompatible foot sizes or mounting height, and patients whose current foot already has heel-height adjustment.

Why it matters

Who can join: the full rules

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

Where it's running

• 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

Study contacts

• Study coordinator: Aurelie LACROIX
• Email: aurelie.lacroix@ottobock.com
• Phone: 0033 (0)7 86 29 52 03

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.