Active not recruitingNAINTERVENTIONAL

Acceptability of an Interim Socket System

This study is exploring a new type of temporary leg socket, called a 'confidence socket,' for people who have had a below-knee amputation. When someone first has an amputation, their leg changes shape a lot, which often means they need many different sockets. This can slow down their recovery. The 'confidence socket' is made from a special plastic that can be easily warmed up and reshaped. This means the same socket can be adjusted as your leg changes, rather than needing a completely new one. This study wants to find out if patients and healthcare providers think this new socket is a good idea and if it helps people get moving sooner.

At a glance

Status

Active not recruiting

Phase

Sponsor

University of Hull

Enrolment target

Start

12 Oct 2021

Estimated completion

28 Nov 2024

Amputation

What is this study about?

When someone has a below-knee amputation, the remaining part of their leg, called the residual limb, changes shape quite a bit in the first year. This is because swelling goes down and muscles can shrink. With the usual way of doing things, these changes often mean you need many different sockets for your artificial leg, or that your existing socket needs a lot of adjustments.

Changing sockets so often can be difficult and slow down your progress. It can feel like a setback if your socket doesn't fit well, making it hard to walk or do your exercises. This means it takes longer to get back on your feet and can use up more healthcare resources.

Researchers are looking at a newer technology called an 'interim' or 'confidence' socket. This socket is made from a special plastic material that can be moulded to your leg in just one visit. The great thing about this material is that it can be heated up and reshaped quickly and comfortably. So, as your leg changes shape, the same socket can be adjusted to fit properly, rather than you needing a whole new one. The study wants to see if this new socket helps patients and healthcare staff during the first three months of using an artificial limb.

Key takeaways

The study tests a new, adjustable temporary leg socket.
It aims to make getting your first prosthetic leg smoother and quicker.
The 'confidence socket' can be reshaped as your leg changes.
The study wants patient and staff feedback on this new approach.
You will still receive your normal physiotherapy.
Taking part is voluntary, and you can withdraw anytime.

Who may be eligible?

To join this study, you need to be over 18 years old and have recently had a below-knee amputation (in the last six months). The healthcare team looking after you must also think you are ready to have your first artificial leg fitted.

You also need to be able to understand written English and give your permission to take part. You cannot join if you are under 18, have had a different type of amputation (like at the knee or hip), or if your leg is a certain size or shape.

There are also some health reasons that would prevent you from joining, such as having certain medical conditions that affect your memory or your ability to handle the artificial limb, or if you simply don't want to try this new socket.

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 over 18 years old?
Did you have a below-knee amputation within the last 6 months?
Has your medical team said you're ready for an artificial leg?
Can you understand written English?
Are you able to manage sweating or allergies to prosthetic liners?
Do you feel comfortable trying a new type of socket?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll still have your usual physiotherapy leading up to your first appointment for a prosthetic leg. However, instead of getting a standard socket, you'll be fitted with the 'confidence socket.' The other parts of your artificial leg, like the foot, will be chosen as usual.

Once your confidence socket is ready, you'll start your regular physiotherapy and rehabilitation. During the study, you'll be asked about your experiences with the confidence socket through interviews. The study will last for the first three months after you receive your socket.

Potential risks and benefits

Taking part in this study could potentially mean you get your first artificial leg sooner and have fewer changes to your socket as your leg changes shape. This might make your journey to recovery smoother and more comfortable. However, as this is a new approach, there might be unknown comfort issues or adaptations required. You will receive standard care for the other parts of your prosthesis and therapy. Remember, you can decide to stop being part of the study at any time, for any reason, without it affecting your usual healthcare.

Locations (2)

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

University Hospitals Dorset NHS Foundation Trust
Verified postcode
Bournemouth, United Kingdom
Portsmouth Hospitals University NHS Trust
Verified postcode
Portsmouth, United Kingdom

Common questions

What is a 'confidence socket'?

It's a new type of temporary socket for your artificial leg that can be easily reshaped to fit as your leg changes size.

Why is this study being done?

The study wants to see if this new socket is better and more convenient for patients and healthcare staff compared to traditional temporary sockets.

How long will I be in the study?

You'll be involved during the first three months after you receive your confidence socket.

What if I don't like the new socket?

You can leave the study at any time, and it won't affect your regular medical care.

Will my usual physiotherapy change?

No, you will still receive your usual physiotherapy rehabilitation once you have your confidence socket.