RecruitingNAINTERVENTIONAL

Evaluation of Percutaneous Cryoneurotomy Compared to Surgical Open Neurotomy for the Management of Equinovarus Foot Deformity in Patients With Refractory Lower Limb Spasticity After Stroke

This research, called the CRYOSTROKE study, is looking into two ways to treat a common foot problem that can happen after a stroke. Some stroke survivors develop stiff, inward-turning feet, known as equinovarus foot, due to muscle tightness (spasticity). This can make walking difficult. The study compares a traditional surgical operation (surgical neurotomy) with a newer, less invasive method called cryoneurotomy. Cryoneurotomy uses freezing temperatures to help relieve the muscle tightness. Researchers want to find out which treatment works best to reduce spasticity 90 days after the procedure and if these effects last for a full year. The goal is to improve walking and quality of life for people living with this condition.

At a glance

Status

Recruiting

Phase

Sponsor

Poitiers University Hospital

Enrolment target

114

Start

09 Jul 2025

Estimated completion

09 Jun 2029

Stroke Equinovarus Foot Refractory Lower Limb Spasticity

What is this study about?

When someone has a stroke, it can sometimes affect how their brain controls their muscles. This can lead to a condition called spasticity, where muscles become very stiff and tight. For many stroke survivors, this can affect their legs and feet, leading to a condition called equinovarus foot. This means the foot turns inwards and points downwards, making it hard to walk, get around, and participate in daily activities.

Currently, there are a few ways to manage this problem. One common approach is using special injections (like botulinum toxin) to relax the muscles, but these effects are temporary and require repeat treatments. Another, more permanent option is surgery, where nerves are cut to reduce muscle tightness. While effective, surgery is a significant procedure with its own risks and recovery time.

This study is exploring a newer, less invasive treatment called cryoneurotomy. This method involves using very cold temperatures to target and temporarily block the nerves that cause the spasticity. The aim is to achieve similar long-lasting relief to traditional surgery but with a potentially quicker recovery and fewer risks. Researchers are carefully comparing cryoneurotomy with traditional surgery to see which one is safer and more effective in helping people with equinovarus foot improve their walking and overall quality of life after a stroke. They will follow participants for 12 months to see how well the treatments work over time.

Key takeaways

Study compares surgery vs. freezing for stiff feet after stroke.
Aims to improve walking and reduce muscle tightness.
Participation involves receiving one of two treatments and follow-up for a year.
Could help find better, less invasive treatments for stroke survivors.
Your decision to join is voluntary and you can leave at any time.

Who may be eligible?

To join this study, you need to be at least 18 years old and have had a stroke more than six months ago. Importantly, your stroke must have caused your foot to turn inwards and point downwards (equinovarus foot) due to muscle stiffness. Doctors will perform a special test to see if your nerve responds well to a temporary block, which helps decide if you're suitable for the treatments being studied. You also need to be well enough to have surgery if that's the treatment you receive, and you shouldn't have any major mental health problems that would make it difficult to understand or take part in the study.

There are several reasons why someone might not be able to join. For example, if you've already had nerve procedures, freezing treatments, or surgery on the same part of your leg. You also can't have received botulinum toxin injections in your leg within the last three months or certain anti-spasm medications just before the nerve test. Severe medical conditions, allergies to cold (for the cryoneurotomy group), or if your foot is severely fixed in a position that can't be corrected, would also prevent you from taking part.

The study also cannot include pregnant or breastfeeding women, people in prison, or those who are unable to give their clear consent to participate.

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 at least 18 years old?
Did you have a stroke more than 6 months ago?
Do you have a stiff, inward-turning foot (equinovarus foot) due to your stroke?
Are you generally well enough for surgery?
Have you avoided botox injections in your leg in the last 3 months?
Are you able to understand and agree to take part in a study?

Answer every question to see your result.

What does participation involve?

If you join this study, you would be randomly assigned to receive one of two treatments: either traditional surgery or the newer cryoneurotomy procedure. Both treatments aim to reduce muscle stiffness in your foot. You will have several appointments for assessments before, during, and after your treatment. These will include checks on your muscle stiffness, how well you can move your foot, and how the treatment is affecting your daily life and pain levels.

After your treatment, you'll be followed up regularly. The main check will be 90 days (about 3 months) after your procedure to see how well it's working. Researchers will then continue to check in with you for a full year (12 months) to make sure any improvements last. You will need to attend all scheduled visits to help the researchers gather full information about the long-term effects of each treatment.

Potential risks and benefits

Participating in this study might offer you a chance to improve your foot stiffness and walking ability, potentially leading to a better quality of life. You'd also be contributing valuable information to help others who develop this condition after a stroke. However, as with any medical procedure, there are potential risks, including discomfort, infection, or other complications related to either surgery or the freezing technique. The study aims to compare safety, but individual risks will be discussed fully with you by the medical team. 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 (7)

Hôpital Raymond Pointcarré
Verified postcode
Garches, France· Recruiting
CHRU Montpellier
Verified postcode
Montpellier, France· Recruiting
C.H.U. Poitiers
Verified postcode
Poitiers, France· Recruiting
CHU Rennes
Verified postcode
Rennes, France· Recruiting
Pôle Saint-Hélier
Verified postcode
Rennes, France· Recruiting
CHU Saint-Etienne
Verified postcode
Saint-Etienne, France· Recruiting
Hôpital Purpan
Verified postcode
Toulouse, France· Not yet recruiting

Common questions

What is 'equinovarus foot'?

It's when your foot turns inwards and points downwards, making it hard to walk. It's often caused by muscle stiffness after a stroke.

What is 'spasticity'?

Spasticity is when muscles become very stiff and tight, sometimes uncontrollably, often due to brain or spinal cord damage like from a stroke.

What's the difference between the two treatments?

One is a traditional surgical operation (surgical neurotomy), and the other is a newer, less invasive method that uses freezing temperatures (cryoneurotomy) to calm nerve activity.

Will I get to choose which treatment I receive?

No, if you join, you will be randomly assigned to one of the two treatments, like flipping a coin, to ensure a fair comparison.

How long will the study last for me?

You will be followed for a full year (12 months) to see how well the treatment works over time.

How to find out more

Romain DAVID, MD

romain.david@chu-poitiers.fr +33 5 49 44 44 54 Official trial record

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