RecruitingPhase IIIInterventional

STEPFORWARD: A comparison between usual care “rigid” prosthetic feet and hydraulic “flexible” feet for quality of life in patients with a below-knee amputation who have limited mobility

This study, called STEPFORWARD, looks at how different types of prosthetic feet affect people with a below-knee amputation who find walking challenging. Many people in the UK have a lower-leg amputation, often due to diabetes, and find everyday tasks like walking on slopes or uneven ground difficult with standard, rigid prosthetic feet. The research aims to find out if a newer, more flexible prosthetic foot, which uses a special hydraulic system to adjust itself, can make a real difference. Researchers want to see if these flexible feet improve comfort, confidence, and overall quality of life, and reduce trips and falls, compared to the usual stiff feet. The study’s results will help the NHS decide if these flexible feet should be available to more people.

At a glance

Status

Recruiting

Phase

Phase III

Sponsor

Hull University Teaching Hospitals NHS Trust

Enrolment target

266

Start

01 Jun 2026

Estimated completion

30 Jun 2028

Patients with a below-knee amputation categorised as having limited mobility

What is this study about?

In the UK, thousands of people each year have a lower-leg amputation, often because of diabetes or poor blood circulation. Many of these individuals are over 50 and find that walking, especially outdoors or on uneven surfaces, can be tricky. Simple activities like climbing stairs or walking on a sloping path can feel unsafe or uncomfortable. Currently, most people use a standard NHS prosthetic foot, which is quite stiff and doesn’t adapt well to different types of ground. This can sometimes lead to falls and may make people feel less confident when moving around.

Newer, more flexible prosthetic feet exist, but we don't yet have enough clear information to show how much they truly help people or if they are a good investment for the NHS. Because of this, these flexible feet aren't commonly offered. The STEPFORWARD study wants to change that by investigating whether a particular type of flexible prosthetic foot can make everyday life easier and safer. This innovative foot uses a hydraulic system, which helps it automatically adjust to different surfaces as you walk.

The main goal of this study is to understand if using these flexible, self-adjusting feet improves comfort, confidence, safety, and overall quality of life for people with a below-knee amputation, compared to the standard rigid feet. The findings will be really important because they will help the NHS decide whether to make these flexible prosthetic feet more widely available, potentially improving the lives of many people.

Key takeaways

Compares standard vs. flexible prosthetic feet for below-knee amputees.
Aims to improve comfort, confidence, safety, and quality of life.
Participation involves 12 months of using a prosthetic foot and completing questionnaires.
No extra risks; your usual care continues.
Results will help the NHS decide on wider access to flexible prosthetic feet.
Recruiting adults aged 18+ with a below-knee amputation and limited mobility.

Who may be eligible?

This study is looking for around 266 adults aged 18 and over who have had a below-knee amputation on one leg. To be part of the study, you should already be using a prosthetic limb and find that your walking is somewhat limited, for example, if you can only walk short distances on flat ground, even with walking aids, or if you only walk outdoors in good weather.

You would also need to be currently using a standard, stiff prosthetic foot that doesn't have a hydraulic system. It's important that you have finished your initial rehabilitation after your amputation and have a well-fitting socket for your prosthetic. A team of medical experts will also need to agree that a flexible foot would be suitable for you.

There are a few reasons why you might not be able to join. For example, if you have an open wound or infection on your remaining limb, or if your current prosthetic socket doesn't fit properly (though you might be able to join later once these issues are sorted). Also, if you weigh more than 100 kg or have a very long residual limb, the flexible foot might not be suitable. People with severe memory problems would also not be able to take part.

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.

Are you 18 years old or older?
Do you have a below-knee amputation on one leg?
Are you already using a prosthetic leg and find walking somewhat limited?
Are you currently using a standard, stiff prosthetic foot?
Do you have a well-fitting socket for your prosthetic?

Answer every question to see your result.

What does participation involve?

If you join the study, you'll be one of about 266 adults taking part across approximately 12 NHS prosthetic centres in the UK. Everyone in the study already uses a prosthetic limb. You'll be randomly assigned to use either the newer, flexible hydraulic foot or your usual, standard rigid foot – this is like flipping a coin to decide.

You'll be part of the study for 12 months. During this time, you'll be asked to fill out six short questionnaires. These will ask about your quality of life, how comfortable and confident you feel, and your general mood. The study will also keep track of your walking ability, how active you are, and any trips or falls you might have. Some participants will also wear a small device to monitor how much they walk.

Throughout the study, your usual care for your prosthetic socket and limb will continue as normal. You won't have any treatments stopped or withheld because you're taking part. A small number of participants, along with staff who provide prosthetics, will also be invited to have interviews. These chats will help researchers understand your real-life experiences with the feet and how practical they are.

Potential risks and benefits

If you are in the group using the flexible foot, you might find that you become more comfortable or can move more easily, but we can't promise this will happen for everyone. Even if you don't directly feel a benefit, the information gathered from your participation could be really helpful in improving care for other people with below-knee amputations in the future. There are no extra risks or disadvantages from taking part in this study; your normal care will continue, and no treatments will be stopped. If you do get the flexible foot, you might feel a bit uncomfortable for a short while as you get used to it, which is normal when changing any prosthetic. You'll be asked to complete some questionnaires, and if any questions feel upsetting, you don't have to answer them, and support will be available. You are free to withdraw from the study at any time.

Locations (12)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Hull University Teaching Hospitals NHS Trust
City only
Hull, England
Portsmouth Hospitals University NHS Trust
City only
Portsmouth, England
Royal National Orthopaedic Hospital NHS Trust
City only
Stanmore, England
Livewell Southwest Prosthetic Service
Unverified
Plmouth, England
The Queen Elizabeth University Hospital Glasgow
City only
Glasgow, Scotland
Birmingham Community Healthcare NHS Foundation Trust
City only
Birmingham, England
Cambridge University Hospitals NHS Foundation Trust
City only
Cambridge, England
Sheffield Teaching Hospitals NHS Foundation Trust
City only
Sheffield, England
Nottingham University Hospitals NHS Trust - Queen's Medical Centre Campus
City only
Nottingham, England
North Cumbria Integrated Care NHS Foundation Trust
City only
Carlisle, England
Wirral University Teaching Hospital NHS Foundation Trust
City only
Wirral, England
North London NHS Foundation Trust
Unverified
London, England

Common questions

What is a 'hydraulic' prosthetic foot?

It's a special type of prosthetic foot that uses a system like a car shock absorber to help it adjust automatically when you walk on different surfaces, like slopes or uneven ground, making it more flexible.

Will I have to pay for the flexible foot if I'm in that group?

No, if you're chosen for the flexible foot group, the study will provide it. This research also looks at whether the new foot is good value for money for the NHS.

How often will I need to complete questionnaires?

You'll be asked to complete six short questionnaires over the 12 months you are part of the study.

What if I get used to the new foot and then the study ends?

The study aims to help the NHS decide if these feet should be more widely available long-term. Your healthcare team will discuss your options with you at the end of the study.

Can I leave the study if I change my mind?

Yes, you can choose to stop participating in the study at any time, for any reason, without it affecting your usual care.

How to find out more

Amy Wilkinson

amy.wilkinson@hyms.ac.uk +44 1482 464897 Official trial record

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