STEPFORWARD

Summary

Every year in the UK, more than 2,000 people have a lower-leg (below-knee) amputation. Many people who have a below-knee amputation find walking difficult, particularly outdoors, on uneven ground, on slopes or when using stairs. These difficulties can affect comfort, confidence and safety, and may increase the risk of trips and falls.

Most people with these difficulties use a standard NHS prosthetic foot. These feet are relatively stiff and may not adapt well to different surfaces. Newer prosthetic feet are available that can automatically adjust to the ground using a hydraulic system, but there is currently not enough evidence to know whether they provide meaningful benefits for people with limited mobility or whether they offer good value for the NHS.

This study will look at whether a flexible, self-adjusting prosthetic foot can make everyday walking easier, safer and more comfortable compared with a standard rigid prosthetic foot.

Around 266 adults with a below-knee amputation and limited mobility will take part at approximately 12 NHS prosthetic centres across the UK. Everyone taking part will already use a prosthesis. Participants will be randomly assigned to use either the flexible hydraulic foot or the standard rigid foot.

What we plan to do

Participants will take part in the study for 12 months. During this time, they will be asked to complete questionnaires about their quality of life, comfort, confidence and wellbeing.

The study team will also collect information about participants' walking ability, activity levels, and any trips or falls they experience. Some participants will be asked to wear a small activity monitor to record how much they walk during everyday life.

The researchers will also look at whether the flexible hydraulic foot provides good value for money for the NHS.

A smaller group of participants, along with prosthetic staff, will be invited to take part in interviews. These interviews will provide an opportunity to share experiences of using the prosthetic foot and help the researchers understand how practical it is to use in everyday life and clinical care.

The information collected will help the researchers understand whether flexible, self-adjusting prosthetic feet could improve comfort, confidence, safety and quality of life for people with below-knee amputations and limited mobility.

The results will help inform future decisions about whether these types of prosthetic feet should be made more widely available through the NHS.