RecruitingNAINTERVENTIONAL

Effects of Local Vibrations Program of Dorsiflexor Muscles on Neuromotor Recovery in Subacute Stroke Patients.

This study is investigating if adding gentle, localised vibrations to specific leg muscles can help stroke patients recover their movement and walking ability more effectively. Previous research suggests that vibrations might positively affect how nerves and muscles work together. Researchers want to see if these vibrations, given to the ankle-lifting muscles (dorsiflexors), improve walking speed better than standard physiotherapy alone. One group of patients will receive the vibrations, while another group will have a 'sham' vibration (a placebo) alongside their usual care. This helps scientists understand if the vibrations themselves are making a difference in how well people recover after a stroke.

At a glance

Status

Recruiting

Phase

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Enrolment target

Start

12 Mar 2024

Estimated completion

15 May 2027

Stroke Rehabilitation

What is this study about?

This research study is looking into new ways to help people recover after having a stroke. When someone has a stroke, it can sometimes affect how well they can move parts of their body, especially their arms and legs. This study focuses on helping people improve their walking and movement in their legs.

The main idea behind this study is to see if adding gentle vibrations to a specific muscle in the leg can help people recover better. This muscle, called the 'dorsiflexor' muscle, helps you lift your foot, which is really important for walking. Researchers have found in other studies that vibrating a muscle might help the nerves and muscles work together more effectively. The hope is that by adding these targeted vibrations to a person's usual stroke rehabilitation programme, they might get better at walking more quickly or to a greater extent.

Participants in the study will be divided into two groups. One group will receive the gentle vibrations alongside their standard physiotherapy. The other group will have what's called a 'sham' vibration – this means they will experience something that feels like the vibration but isn't actually treating them, acting like a placebo. This helps the researchers figure out if any improvements seen are truly due to the vibrations themselves, or just to the standard rehabilitation. The main thing they will be looking for is if the group receiving the real vibrations shows better improvements in their walking speed.

Key takeaways

This study explores if gentle leg muscle vibrations improve stroke recovery.
It aims to make walking better for people who recently had a stroke.
Participants will receive either real vibrations or a 'sham' (placebo) vibration.
The study measures walking speed and other movements to see the effects.
You can withdraw from the study at any time without affecting your care.

Who may be eligible?

This study is looking for people who have recently had a stroke, specifically between 14 days and 3 months ago. You need to be between 18 and 80 years old, and your stroke should have affected the movement in your legs, making them weaker (doctors use a special scale where your initial score on a leg movement test needs to be less than 4). Your stroke can be either an ischaemic stroke (a blockage) or a haemorrhagic stroke (a bleed).

It's important that your stroke is the only major neurological problem you have. You shouldn't have other long-term nerve conditions that affect your movement. Also, if you've had certain ankle problems or a specific injection (Botulinum toxin) in your lower leg recently, or if you have certain blood clot risks (like phlebitis), you wouldn't be able to join. Your doctors will check all these details carefully. If you're considering joining, you'll need to understand what the study involves and give your written consent.

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.

I am aged between 18 and 80 years old.
I had a stroke between 2 weeks and 3 months ago.
My stroke has affected the strength or movement in my leg.
I do not have other serious nerve conditions apart from my stroke.
I have not had a Botulinum toxin injection in my leg recently.

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will continue with your usual stroke rehabilitation. In addition, you will be assigned to one of two groups: one group will receive gentle vibrations to a muscle in their lower leg, and the other group will receive a 'sham' (placebo) vibration. You won't know which group you are in. Researchers will take various measurements to see how your recovery is progressing.

These measurements will include walking tests (like seeing how far you can walk in 2 minutes or over 10 metres), assessments of your muscle strength and movement, questionnaires about your daily activities and quality of life, and possibly tests that measure muscle activity (electromyograms) or how you walk using special equipment. These assessments help the research team understand if the vibrations are making a difference. The total time you'll be involved in the study will depend on the full study plan, but treatments will start during the subacute phase of stroke recovery (within 3 months of your stroke).

Potential risks and benefits

Taking part in this study might offer you the potential benefit of improved walking ability and movement compared to standard rehabilitation alone, but there's no guarantee. There may be some minor discomfort from the vibration device, and like any medical study, there's always a small chance of unforeseen effects, though the vibrations are generally considered safe. You will be closely monitored by medical professionals throughout the study. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (7)

Centre Hospitalier Georges Claudinon
Verified postcode
Le Chambon-Feugerolles, France· Not yet recruiting
Hôpital Marrel
Verified postcode
Rive-de-Gier, France· Recruiting
Centre Hospitalier de Roanne
Verified postcode
Roanne, France· Not yet recruiting
Service de SSR Val-Rosay
Verified postcode
Saint-Didier-au-Mont-d'Or, France· Not yet recruiting
Hôpital Bellevue, CHU de Saint-etienne
Verified postcode
Saint-Etienne, France· Recruiting
Service de SSR du Centre Le Clos Champirol
Verified postcode
Saint-Etienne, France· Not yet recruiting
Hospices Civils de Lyon, site Henry Gabrielle
Verified postcode
Saint-Genis-Laval, France· Not yet recruiting

Common questions

What muscles will be vibrated?

The study will apply gentle vibrations to the 'dorsiflexor' muscles in your leg. These are the muscles that help you lift your foot upwards, which is important for walking.

Will I feel the vibration?

Yes, if you are in the vibration group, you will feel a gentle sensation. If you are in the 'sham' vibration group, you might feel something similar but without the active treatment.

How long will the study treatment last?

The study focuses on the 'subacute' phase of stroke recovery, which means between 14 days and 3 months after your stroke. The exact duration of the vibration sessions will be detailed by the study team.

Can I stop participating if I want to?

Yes, absolutely. You can withdraw from the study at any time, for any reason, without it affecting your medical care or relationship with your healthcare team.

What is 'standard rehabilitation'?

Standard rehabilitation refers to the usual physiotherapy and other therapies you receive to help you recover after a stroke, which will continue during this study.

How to find out more

Bruno FERNANDEZ, MD

bruno.fernandez@chu-st-etienne.fr (0)477120638 Official trial record

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