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RecruitingNAINTERVENTIONAL

Study on a Prosthetic Foot With Adjustable Heel Height

Living with a leg amputation can sometimes limit shoe choices, as most prosthetic feet have a fixed heel height. This means people often have to wear shoes with the same heel height all the time to walk comfortably and safely. The Taleo Adjust is a new kind of prosthetic foot that lets you change the heel height, from completely flat up to 7cm. This means you could wear different shoes for different occasions – from flats to heels – and even walk barefoot. This study aims to find out if being able to choose various shoe styles with this adjustable prosthetic foot helps people feel better about their appearance and take part more easily in different activities. It's about giving people more freedom and choice in their daily lives after an amputation.

At a glance

Status
Recruiting
Phase
NA
Sponsor
Otto Bock France SNC
Enrolment target
30
Start
08 Oct 2025
Estimated completion
06 Jun 2026

What is this study about?

For people who have had a leg amputation, choosing a prosthetic or artificial limb means finding one that helps them get around well and feel good about themselves. A very important part of this is the prosthetic foot. What many people don't realise is that most prosthetic feet are designed for a specific heel height, usually quite low. This means if you want to walk safely and comfortably, you often have to stick to shoes with that exact heel height. Imagine only being able to wear one type of shoe – it can be quite limiting for everyday life, whether it's for work, social events, or just relaxing at home.

This study is looking at a new prosthetic foot called the Taleo Adjust. The really clever thing about this foot is that it has a special ankle that allows you to change the heel height. You can go from wearing completely flat shoes, like ballet pumps or flip-flops, all the way up to shoes with a 7cm heel. This means you could wear different shoes for different activities or outfits – high heels for a special occasion, sturdy boots for gardening, or even walk barefoot around the house. The design ensures that even with these changes, your walking remains comfortable and safe.

The main goal of this study is to understand what difference this adjustable prosthetic foot can make to people's lives. We want to see if having the freedom to choose different shoes helps people feel more confident about how they look and allows them to take part in more activities, whether that's at work, with family, or out with friends. It's about giving people more flexibility and choice, which can be a big step towards feeling more independent and comfortable after an amputation.

Key takeaways

  • New prosthetic foot allows adjustable shoe heel height (0-7cm).
  • Aims to improve appearance and participation for people with lower limb amputations.
  • No medication involved; focus is on a new prosthetic device.
  • Suitable for adults already using some types of prosthetic feet.
  • Participation includes using the foot and completing questionnaires.

Who may be eligible?

To join this study, you need to be an adult (18 years or older) who has had a major amputation in one of your lower legs (either above or below the knee). You should already be comfortable using a prosthetic foot that stores and returns energy for at least three months. It's also important that you want to be able to wear different types of shoes with various heel heights, or even walk barefoot.

There are some reasons why you might not be able to join. For example, if you do high-impact sports, have had a hip amputation (where the leg is removed at the hip joint), or if your remaining limb isn't stable or your current socket doesn’t fit well. Also, this study might not be suitable if your weight is over 115kg, your foot size is outside a certain range (smaller than a UK size 3 or bigger than a UK size 13), or if the prosthetic foot won't fit your leg properly for technical reasons. You also can't be in the study if your current prosthetic foot already has an adjustable heel.

Finally, you need to be available for the entire study duration, be able to understand instructions and fill in questionnaires, and not be part of another study. Pregnant women or those in an emergency situation also cannot take part. The research team will check all these points to see if this study is right for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Do you have a lower leg amputation (above or below the knee)?
  3. Have you been using a special 'energy-storing' prosthetic foot for at least 3 months?
  4. Do you wish you could wear different shoes with varying heel heights, or walk barefoot?
  5. Are you able to attend all study visits and fill out questionnaires?
  6. Do you weigh less than 115kg and is your foot size within a regular range (not extremely small or large)?
Answer every question to see your result.

What does participation involve?

If you join this study, the main part will involve using the new Taleo Adjust prosthetic foot. You'll likely have some initial appointments where the new foot is fitted and adjusted for you. During the study, you'll be asked to try out different heel heights and shoes, just as you would in your daily life. You won't be given any medication as part of this study.

The research team will want to understand your experiences, so you will be asked to fill in questionnaires. These questions will be about how you feel about your appearance and how easily you can take part in different activities while using the Taleo Adjust foot. The study will look at how your daily life changes with this new foot. The total duration of your participation will be explained by the study team, but it will involve a period of using the new prosthetic foot and then coming back for assessments.

Potential risks and benefits

Taking part in this study may offer several potential benefits. The main benefit is that you would get to try a new prosthetic foot that allows you the freedom to choose shoes with different heel heights, and even walk barefoot. This could lead to feeling more confident about your appearance and make it easier to participate in various social or work activities. However, it's important to remember that there's no guarantee everyone will experience these benefits. As with any new device, there's always a small chance of unexpected discomfort or issues with the fitting, though the team will work to minimise these. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (5)

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

Common questions

What is the new prosthetic foot called?

It's called the Taleo Adjust.

How does the Taleo Adjust work?

It has a special ankle that lets you change the heel height of your shoe, from flat up to 7cm, without affecting your walking.

Why is this study important?

It aims to see if having more shoe choices helps people feel better about their appearance and take part more in daily life after an amputation.

Will I have to take any medicine in this study?

No, this study does not involve any medication.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time without giving a reason, and it won't affect your medical care.

How to find out more

Aurelie LACROIX

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Study on a Prosthetic Foot With Adjustable Heel Height…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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