RecruitingNAINTERVENTIONAL

Comparing Digitally and Traditionally Made Ankle Foot Orthoses

This research is looking at two ways to make ankle-foot supports, called AFOs, which help people with conditions like stroke or cerebral palsy walk better. One way is the traditional method, using plaster casts, which takes a lot of time and effort. The other is a newer, digital method using 3D scanning and printing, which could be quicker and cheaper. We want to find out if these digitally made AFOs provide the same benefits to patients as the traditionally made ones. The study will look at how happy patients are with their AFOs, how well they work, and the costs involved. This will help decide if digital AFOs can be a good alternative, leading to better care and potentially lower costs in the future.

At a glance

Status

Recruiting

Phase

Sponsor

Holland Bloorview Kids Rehabilitation Hospital

Enrolment target

Start

05 Sep 2025

Estimated completion

31 Mar 2027

Flaccid Paresis Spastic Paresis Cerebral Palsy Stroke Spinal Cord Injury Spina Bifida Traumatic Peripheral Nerve Injury

What is this study about?

This study is comparing two different ways of making special leg supports called Ankle-Foot Orthoses, or AFOs. AFOs are custom-made devices worn around the ankle and foot to help people who have weakness or control issues in their legs, often due to conditions like stroke, cerebral palsy, or spinal cord injury. They help with walking and standing.

The first method, the traditional one, involves taking a plaster cast of a person's leg. This cast is then used to create a mold from which the AFO is shaped. It's a tried-and-true method, but it can be quite time-consuming and needs a lot of hands-on work. The second method is newer and uses modern digital technology, like 3D scanning to get a precise image of your leg, and then 3D printing to create the AFO. The idea behind this digital approach is that it might be faster and less expensive to produce.

Our main goal with this research is to see if AFOs made using this digital technology work just as well as the ones made in the traditional way. We want to know if they provide the same support, comfort, and help with walking. By comparing both methods, we hope to understand if the digital approach can offer a more efficient and cost-effective way to provide these important supports, eventually leading to better and more accessible care for everyone who needs them.

Key takeaways

Compares traditional plaster-made AFOs with new 3D-printed AFOs.
Aims to see if digital AFOs work as well, but might be faster or cheaper.
Involves trying both types of AFOs over a period.
Suitable for people aged 8+ with leg weakness needing AFOs for walking.
Your feedback on comfort and function is important for the research.
You can stop participating at any time.

Who may be eligible?

To join this study, you need to be at least 8 years old. You should have weakness or difficulty controlling your leg muscles due to conditions like cerebral palsy, stroke, spinal cord injury, spina bifida, or nerve damage. This weakness should make it necessary for you to use an AFO for walking.

You must already use an AFO or need a new one to help you move around. You should also be able to walk by yourself, even if you use walking aids like crutches or a stick. It's important that you can understand and complete questionnaires with a little help if needed. Also, your AFO must be funded through the Assistive Devices Program (ADP).

You wouldn't be able to join if you need an AFO mainly for treating wounds, if you don't use your AFO for walking, if you have feet that can't feel much or have a history of sores, or if you've never used an AFO before.

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 8 years old or older?
Do you use an AFO or need one because of leg weakness from a condition like stroke or cerebral palsy?
Can you walk on your own, even if you use a walking aid?
Have you used an AFO before (this study is not for first-time users)?
Is your AFO usually funded by the Assistive Devices Program (ADP)?
Do you usually wear your AFO for walking, rather than for healing wounds?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll try out two different types of AFOs: one made the traditional way and one made using digital technology. You'll wear each type for a set period. In the first phase (Part A), you'll wear one type of AFO for a while, and then switch to the other type. After this, there's a longer-term evaluation (Part B) where you'll continue to wear both AFO types as chosen by the study, so we can see how they perform over time.

Throughout the study, you'll have appointments where researchers will check how well the AFOs fit, how comfortably you wear them, and how they help you with your daily activities. You'll also be asked to complete questionnaires about your experiences and satisfaction with each AFO. There are no medications involved in this study. The total duration of your participation will depend on the specifics of the wear periods, but it will involve switching AFOs and follow-up assessments.

Potential risks and benefits

Taking part in this study could offer some benefits, as you'll be trying out potentially new and improved AFO designs. This might lead to an AFO that fits better, is more comfortable, or helps you move more easily. You'll also be contributing to research that could improve how AFOs are made for many people in the future. As with any new medical device, there's a small chance of discomfort or skin irritation, and the AFOs might not work perfectly for everyone. All AFOs will be carefully fitted and monitored by specialists to keep you safe. Remember, participating in any research study is always your choice, and you have the right to withdraw at any time without giving a reason, and this won't affect your medical care.

Locations (2)

Boundless Biomechanical Bracing
Verified postcode
Mississauga, Canada· Not yet recruiting
Holland Bloorview Kids Rehabilitation Hospital
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is an AFO?

An AFO, or Ankle-Foot Orthosis, is a special support worn around your ankle and foot to help with walking and movement if your leg muscles are weak or difficult to control.

What's the difference between traditional and digital AFOs?

Traditional AFOs are made using a plaster cast of your leg. Digital AFOs are made using 3D scanning and printing, which is a newer, potentially faster method.

Will I get to choose which AFO I wear?

During the study, you will try both types of AFOs for specific periods so we can compare them fairly.

Is this study safe?

Yes, your safety is important. All AFOs will be fitted and monitored by experts, and any potential discomfort will be addressed.

What if I change my mind about participating?

You are free to leave the study at any time, for any reason, and it won't affect your ongoing medical care.

How to find out more

Calvin Ngan, PhD

cngan@hollandbloorview.ca 416-425-6220 Official trial record

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