RecruitingNAINTERVENTIONAL

Efficacy of a Personalized Rehabilitation Program of Facial Involvement in Systemic Sclerosis

This study is for people with systemic sclerosis, a condition that can make skin, including on the face, stiff. This can cause problems with opening the mouth, eating, and dental care, affecting how people feel about themselves and their quality of life. Current medications often don't help much with these face issues. This research wants to find out if a special, custom-made exercise program for the face can make a real difference. Participants will either get this new personalized program or continue with standard care. The goal is to see if the personalized exercises can reduce face-related difficulties and improve comfort and appearance more effectively.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Strasbourg, France

Enrolment target

Start

13 Oct 2022

Estimated completion

01 Dec 2029

Systemic Sclerosis Face Facial Involvement Rehabilitation

What is this study about?

Systemic sclerosis is a rare condition that affects the body's immune system, leading to changes in small blood vessels and hardening of tissues, often including the skin. When this affects the face, it can cause a lot of discomfort and make everyday things like opening your mouth, eating, and looking after your teeth much harder. This can really impact how you feel about your appearance and your overall quality of life.

Even though these face problems are common and can be very difficult, they aren't always given the attention they need, and current medicines don't always help a great deal. However, there's a belief that certain exercises for the face could significantly improve these issues. But, at the moment, facial exercises aren't a standard part of care for people with systemic sclerosis.

This study is designed to explore whether a personalized exercise program for the face can be truly effective. We'll compare this special program with the usual care people receive to see if it helps reduce the difficulties linked to face involvement in systemic sclerosis, and ultimately, improve people's quality of life. This research aims to understand if there's a better way to manage these challenging face-related symptoms.

Key takeaways

This study explores a new exercise program for face problems in systemic sclerosis.
It aims to make everyday tasks like eating and speaking easier.
The program is personalized, meaning it's made to fit your specific needs.
Current medications don't always help with facial stiffness, so new approaches are needed.
The study compares the personalized program with standard care to see which is more effective.

Who may be eligible?

To join this study, you need to be at least 18 years old and have a confirmed diagnosis of systemic sclerosis with face involvement. This means you experience some difficulties with your face due to your condition, which will be checked using a special questionnaire.

It's important that any medication you're taking for your condition has been stable for at least a month before starting the study. You must also be able to understand what the study involves and agree to take part, and be registered with a health insurance scheme.

There are a few reasons why you might not be able to join. If you are pregnant, have previously taken part in a face exercise program for your condition, or are under legal protection that prevents you from making your own choices, you won't be able to participate. Also, if there's any reason you can't clearly understand or provide information about yourself, you wouldn't be able to join.

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?
Have you been diagnosed with systemic sclerosis, and does it affect your face?
Has your current medication for systemic sclerosis been unchanged for at least one month?
Are you pregnant? (If yes, you cannot participate).
Are you able to understand and agree to take part in the study?
Have you participated in a face exercise program for your condition before? (If yes, you cannot participate).

Answer every question to see your result.

What does participation involve?

If you join this study, you will either take part in a personalized rehabilitation program for your face or receive standard care. The specific details of what the personalized program involves, such as the types of exercises, the number of sessions, and how long each session lasts, would be explained fully if you decide to take part. You would also have regular check-ups to see how you are getting on and to assess any changes in your facial involvement using questionnaires. The total duration of your participation in the study and the number of visits required would be clearly outlined by the study team.

Potential risks and benefits

Taking part in this study may offer the benefit of potentially improving your face-related symptoms and quality of life if you receive the personalized exercise program. However, as with any new treatment approach, there might be potential risks, which will be fully explained by the study team. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Hôpitaux Universitaire de Strasbourg
Verified postcode
Strasbourg, France· Recruiting

Common questions

What is systemic sclerosis?

It's a rare condition where your body's immune system affects your small blood vessels and can cause your skin and other tissues to become stiff.

Why is my face involved in this study?

Many people with systemic sclerosis experience tightness or stiffness in their face, which can make it hard to open their mouth, eat, or even smile comfortably.

What is a personalized rehabilitation program?

It's a special exercise plan designed specifically for you to help improve the movement and comfort of your face.

Will I have to take new medicines?

This study focuses on exercises, not new medications. Your current medications need to be stable before you can join.

How long will the study last?

The study team will tell you the exact length of time you'll be involved if you decide to participate.

How to find out more

Emmanuel CHATELUS, MD

emmanuel.chatelus@chru-strasbourg.fr +33 3 88 12 71 40 Official trial record

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