Active not recruitingNAINTERVENTIONAL

Single-Subject Research Design on 3D-Printed Prosthetic Sockets

This study is looking at how well new 3D-printed leg sockets work for people who have had their lower leg amputated. Participants will try out both their current socket and a new 3D-printed one. Researchers will check things like how easy it is to move around, keep balance, and how comfortable the sockets feel. The aim is to see if the 3D-printed sockets are a good alternative. Participants will wear each type of socket for about three weeks, with researchers gathering information remotely and through a home visit.

At a glance

Status

Active not recruiting

Phase

Sponsor

University of British Columbia

Enrolment target

Start

17 Jul 2023

Estimated completion

11 Mar 2026

Transtibial Amputees

What is this study about?

This study is exploring a new way to create prosthetic (artificial) leg sockets using 3D printing technology. For someone with an amputation, a well-fitting socket is crucial for comfort and being able to move around. Traditional sockets can be time-consuming to make.

The researchers want to see if these new 3D-printed sockets are just as good, or even better, than the ones people currently use. They will be looking at important everyday things like how easy it is to walk and keep your balance, how useful the socket feels during daily activities, and most importantly, how comfortable it is to wear.

By comparing the new 3D-printed sockets directly with existing ones, the study hopes to find out if this modern technology can offer a comfortable, functional, and possibly more efficient solution for people who use prosthetic legs. This could make a real difference in people's lives.

Key takeaways

Compares current prosthetic sockets with new 3D-printed ones.
Aims to improve comfort, balance, and daily use for people with amputations.
Involves detailed remote assessments over two three-week periods.
Requires a home visit and two clinic visits for fitting.
Your feedback helps advance prosthetic technology.
You can stop participating at any time.

Who may be eligible?

To join this study, you need to be an adult, aged 19 or older, who has had one or both lower legs amputated (this is called a transtibial amputation). You must already have a prosthetic leg that you use regularly, for at least two hours each day. It's also important that your residual limb (the part of your leg left after the amputation) does not have any open wounds.

There are some reasons why you wouldn't be able to join. For example, if you have difficulty filling out surveys or speaking with the research team. Also, if you have both upper arms amputated or have serious health conditions that are not well managed, like unstable diabetes or advanced heart problems, you wouldn't be eligible 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 19 years old or older?
Do you have an amputation below the knee (transtibial amputation) in one or both legs?
Do you currently use a prosthetic leg for at least two hours every day?
Do you have no open wounds on your residual limb?
Are you able to clearly communicate and complete online forms?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll first have a visit at your home from a research assistant. They will set up equipment, show you how to do some simple movement tests, explain how to answer online surveys, and how to record short videos. You'll also fill out some basic information about yourself and your health.

For the first three weeks, you'll continue to wear your current prosthetic leg socket. During this time, you'll regularly do the movement tests and answer online surveys. Then, you'll go to your prosthetic clinic where your limb will be measured and scanned for your new 3D-printed socket. Once the new socket is ready, you'll have another clinic visit to make sure it fits properly.

After that, you'll wear the 3D-printed socket for another three weeks, doing the same movement tests and surveys. At the end, you'll drop off the 3D-printed socket at your clinic. In total, the study involves two three-week periods of wearing different sockets, plus a few visits and regular check-ins with the research team.

Potential risks and benefits

Potential benefits of taking part include getting a specially designed 3D-printed socket to try, which might offer improved comfort or function for you. Your feedback will also help researchers understand if this new technology could benefit others in the future. Potential risks are generally low, mainly involving the time commitment for assessments and wearing a new socket, which might feel different at first. There's a small chance of discomfort associated with trying a new prosthesis, but it will be fitted by an experienced professional. You can leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

University of British Columbia
Verified postcode
Vancouver, Canada

Common questions

What is a 3D-printed prosthetic socket?

It's a custom-made part of an artificial leg, created using a special printer that builds it layer by layer, tailored to your body.

Will I have to pay for the 3D-printed socket?

No, the 3D-printed socket provided for the study purposes is covered by the research study.

How often will I need to be in touch with the study team?

After an initial home visit, you'll mainly complete online surveys and recordings remotely, up to three times a week during each three-week period.

What happens to the 3D-printed socket after the study ends?

You'll return the 3D-printed socket to your prosthetic clinic at the end of the study. It will not be yours to keep.

Will my personal information be kept private?

Yes, all your personal information and scans will be kept secure and confidential, and your identity will be protected.