RecruitingNAINTERVENTIONAL

Evaluation of Tibial Nerve Selective Neurotomy Compared to Botulinum Toxin Injections for Spastic Foot Treatment in Post-stroke Patients According to a Goal-centered Approach

This research is looking at two ways to treat stiff, spastic feet that can happen after a stroke. One is a small operation on a nerve in the leg, and the other is injections of Botulinum Toxin (Botox) into the muscles. Around 1 in 5 to half of people who have had a stroke and are affected on one side get this foot stiffness, which can make walking, wearing shoes, and everyday life difficult or painful. The study wants to see which treatment is better at reducing this stiffness and helping people achieve their personal goals, like being able to walk more easily or feel less pain. It will also look at how these treatments affect balance, self-care, and overall quality of life. This information will help doctors know when to recommend each treatment to stroke patients.

At a glance

Status

Recruiting

Phase

Sponsor

Hospices Civils de Lyon

Enrolment target

Start

02 Jan 2024

Estimated completion

02 Mar 2027

Post Stroke Seizure Spastic Foot

What is this study about?

When someone has a stroke, it can sometimes affect the way their brain controls their muscles. This can lead to a condition called spasticity, where muscles become stiff and tight. For many people, especially after a stroke, this can affect the leg and foot, causing the foot to turn inwards or downwards. This is often called an 'equino-varus foot' and can make it very hard to walk, keep your balance, find comfortable shoes, and simply feel comfortable. In some cases, if not treated, these muscles can get shorter permanently.

Doctors currently have a few ways to help manage this stiffness. This study is focusing on two particular approaches: one involves a very specific operation on a nerve in the lower leg (the tibial nerve), and the other uses injections of a medicine called Botulinum Toxin (Botox) directly into the tight muscles. Both treatments aim to relax these stiff muscles.

The main goal of this research is to compare these two treatments side-by-side to understand which one is more effective at reducing foot stiffness and helping people improve their daily activities. Researchers also want to see how each treatment helps patients achieve their personal goals, like walking more easily or feeling less pain. The results will help doctors make better decisions about which treatment is most suitable for different stroke patients in the future.

Key takeaways

This study compares two treatments for foot stiffness after a stroke: nerve surgery and Botox injections.
The goal is to find which treatment best helps people move easier and improve daily life.
About a quarter to half of stroke survivors experience this foot stiffness.
The study will track personal goals and overall quality of life.
Participation will involve regular check-ups and assessments.
You can stop participating at any time if you change your mind.

Who may be eligible?

To take part in this study, you need to be an adult over 18 years old. You must have experienced a stroke at least one year ago, which has caused weakness on one side of your body and led to stiffness in your foot, where it might turn inwards or downwards. This stiffness must be due to tight muscles in your calf or foot, and doctors need to confirm that the stiffness can be improved, not just caused by a permanently shortened tendon.

You also need to be covered by French health insurance, understand French, and be able to give your permission to join the study (or have a close family member or trusted person give permission if you can't). There are also some specific reasons why you might not be able to join, such as if you are sensitive to Botox, have certain other medical conditions like myasthenia (a muscle weakness condition), or are pregnant or breastfeeding.

If you have any condition that makes it unsafe for you to have general anaesthesia for surgery, or if you are under legal protection, you would also not be able to join this study. The research team will carefully check all these points to make sure the study is safe and right for you.

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 stroke more than one year ago?
Do you have a stiff foot that turns in or down because of muscle tightness?
Are you able to speak and understand French?
Are you covered by French national health insurance?
Are you happy to potentially receive either nerve surgery or Botox injections?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the research team will explain everything to you in detail. You will be assigned to receive either the nerve surgery or the Botox injections. Both treatments aim to help with your foot stiffness. You will have regular appointments where doctors will check your progress, how much movement you have, and how well you can do daily tasks. They will also ask you to complete questionnaires about your quality of life. The study will look at how your personal goals, like walking or wearing shoes, are affected. The exact number of visits and the total length of your participation will be explained by the study team.

Potential risks and benefits

Taking part in this study could offer some benefits, such as potentially reducing your foot stiffness and improving your ability to walk and do daily activities. However, like all medical treatments, there are potential risks associated with both nerve surgery (such as risks of any surgery under general anaesthesia) and Botox injections (such as temporary weakness or side effects from the injection itself). The research team will discuss all possible risks and benefits with you in detail before you decide to join. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (4)

Hôpital Pierre Wertheimer
Verified postcode
Bron, France· Not yet recruiting
AP-HP
Verified postcode
Clichy, France· Not yet recruiting
CHU de Nantes
Verified postcode
Nantes, France· Not yet recruiting
Hôpital Henry Gabrielle
Verified postcode
Saint-Genis-Laval, France· Recruiting

Common questions

What is 'spastic foot'?

It's when the muscles in your foot and lower leg become very tight and stiff after a stroke, often causing your foot to turn inwards or downwards.

What is the nerve surgery called?

It's called 'tibial nerve selective neurotomy', which is a small operation on a specific nerve in your lower leg to help relax the stiff muscles.

What are Botulinum Toxin injections?

These are injections of a medicine (commonly known as Botox) directly into the tight muscles in your leg to help them relax.

Will I know which treatment I'm getting?

No, you won't know if you're getting the surgery or the Botox injections. This helps make the study fair and scientific.

How long has it been since my stroke to join?

You need to have had your stroke over a year ago to be considered for this study.

How to find out more

Jacques LUAUTE, MD,PhD

jacques.luaute@chu-lyon.fr 04 72 35 71 69 Official trial record

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