Not yet recruitingNAINTERVENTIONAL

Evaluation of the NEUROSWING Orthosis on Walking Speed in a Population With Dorsal and/or Plantar Flexor Deficits, With a View to a Reimbursement Application

This study aims to discover if a new type of ankle support, called the NEUROSWING orthosis, can help people walk better. It focuses on individuals who have trouble lifting their foot or pushing off the ground due to conditions such as stroke, multiple sclerosis, or cerebral palsy. Participants will try both the NEUROSWING device and a standard carbon ankle support, each for a two-week period, with a break in between. The main goal is to measure if the NEUROSWING improves walking speed. Researchers will also look at other aspects of walking, like balance and how far someone can walk in six minutes. This information will help decide if this new device should be more widely available.

At a glance

Status

Not yet recruiting

Phase

Sponsor

ÖSSUR France

Enrolment target

Start

31 Jul 2025

Estimated completion

15 Sep 2026

Stroke Multiple Sclerosis Cerebral Palsy Neuromuscular Deficits

What is this study about?

This research study is looking into a new walking aid called the NEUROSWING orthosis. An orthosis is a device applied to the body to support, align, prevent, or correct the function of movable parts. The NEUROSWING is a special kind of ankle support made of carbon that helps with movement. The study wants to see how well it helps people who have trouble controlling their foot movement, specifically when lifting their foot or pushing off the ground. These difficulties can be caused by conditions like a stroke, multiple sclerosis (MS), or cerebral palsy, which affect the brain and nerves.

The main aim is to find out if the NEUROSWING orthosis can help people walk faster and more easily. To do this, researchers will compare it to a common carbon ankle support that people already use. The study is designed to be very thorough, with people trying both devices so the researchers can get a clear picture of how each one affects walking. The results of this study could help more people get access to the NEUROSWING device if it proves to be helpful.

Understanding how different devices impact walking is important because it can significantly improve a person's independence and quality of life. By carefully measuring walking speed and other movements, the researchers hope to show the benefits of the NEUROSWING orthosis. This kind of research is crucial for ensuring that new medical devices are effective and can be used to help more patients in the future.

Key takeaways

This study compares a new ankle support (NEUROSWING) to a standard one.
It aims to see if NEUROSWING improves walking speed and overall movement.
People with walking problems from conditions like stroke or MS are eligible.
Participants will try both devices over about five weeks.
No new medications are involved, only different ankle supports.
The results could help make this new device available to more people.

Who may be eligible?

To join this study, you need to be 18 years old or older. You should have difficulty with your ankle and foot movement, which might include issues like your foot dragging on the ground (foot drop), stiffness, or difficulty balancing when you walk. Your doctor would help determine if these symptoms match what the study is looking for. You must also be able to walk, either with or without walking aids, and this would be the first time you've used either of the specific ankle supports being tested in this study.

There are also some reasons why you might not be able to join. For example, if you have severe memory or thinking problems that would make it hard to do the tests. If you have a serious medical condition that is getting worse quickly, or if you are pregnant, breastfeeding, or just given birth, you wouldn't be able to take part. Also, if you've already used one of the specific ankle supports being studied, or if you are very tall (over 214cm) or very heavy (over 193kg), you wouldn’t be eligible.

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 problems lifting your foot or pushing off the ground when walking?
Can you walk, even if you use a walking aid?
Have you never used the specific NEUROSWING or standard carbon ankle supports before?
Are you able to attend appointments over about five weeks?
Are you not pregnant, breastfeeding, or just given birth?

Answer every question to see your result.

What does participation involve?

If you join this study, you will try two different ankle supports: the NEUROSWING device and a standard carbon ankle support. You will use each device for 14 days (two weeks). There will be a one-week break where you don't wear any support between these two periods. The order in which you try the devices will be decided randomly.

Throughout the study, you will have 12 appointments spread over approximately five weeks. During these appointments, researchers will measure your walking speed using a 10-meter walk test. They will also look at your balance and how well you can move around, for example, by seeing how far you can walk in six minutes. Special equipment will also measure details of your walking, like how long each step takes and how many steps you take per minute. You won't need to take any medicine as part of this study.

Potential risks and benefits

Taking part in this study could potentially improve your walking speed and overall walking ability. You'll also get the chance to try a new ankle support device. However, as with any device, there's a small chance of discomfort or rubbing from wearing the supports. The research team will monitor you closely, and you can withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

IMPR du Bois de Lébisey
Verified postcode
Hérouville-Saint-Clair, France
CMPR Bel-Air
Verified postcode
La Membrolle-sur-Choisille, France

Common questions

What is an orthosis?

An orthosis is a device, like a brace or support, that helps improve the movement or function of a part of your body. In this study, it's an ankle support.

What medical conditions are being studied?

The study focuses on people with walking difficulties due to conditions like stroke, multiple sclerosis (MS), cerebral palsy, and other nerve and muscle issues affecting their feet and ankles.

Will I have to take any new medicines?

No, this study is about evaluating walking supports, not new medicines. You won't be asked to take any new medication as part of the study.

How long will I be in the study?

The study involves two two-week periods of using the ankle supports, separated by a one-week break, plus several assessment visits. In total, it will last about five weeks.

Could I get hurt by being in the study?

The main risks are minor, such as skin irritation or discomfort from wearing the ankle supports. The study team will check on you regularly to make sure you are comfortable and safe.

How to find out more

Emilie Leblong

emilie.leblong@fondationsainthelier.com +33299295099 Official trial record

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