Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05177380

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

Led by University Hospital, Strasbourg, France · Updated on 2026-06-08

60

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research focuses on systemic sclerosis, a rare autoimmune disease that affects the skin and tissues, especially the face. Facial involvement causes stiffness, joint problems, dry mouth, and difficulties with mouth opening, eating, dental care, and weight loss. These issues significantly affect daily life and appearance, but are often overlooked and not well treated with current medicines. The study aims to evaluate if a personalized facial rehabilitation program can improve these facial problems compared to standard care in patients with systemic sclerosis. Participants in the study will be randomly assigned to one of two groups. The experimental group will receive a personalized rehabilitation program consisting of three 2-hour sessions over two weeks at the hospital. These sessions include physiotherapy with facial and mouth massages and exercises, speech therapy for swallowing and speech, educational workshops on dry mouth and oral care, therapeutic makeup, motivational interviewing, a personalized self-rehabilitation notebook, and a video tutorial. They will also perform facial self-rehabilitation at home. The comparison group will receive a standard prescription for facial rehabilitation. During the study, participants will be assessed using the Mouth Handicap In Systemic Sclerosis (MHISS) score at weeks 2, 6, and 12 to evaluate facial function and aesthetics. Other measures include mouth opening distance, skin scoring on the face, pain scale, quality of life questionnaires, weight, and rehabilitation session details. The study involves regular evaluations over 12 weeks to monitor progress, with the main outcome measured at week 6. The total study duration and follow-up will extend to at least 12 weeks.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Diagnosed with systemic sclerosis according to the 2013 ACR/EULAR classification criteria
  • Facial involvement defined by a Mouth Handicap In Systemic Sclerosis (MHISS) score greater than 6
  • Stable immunosuppressive and/or anti-fibrosis treatment for at least 1 month
  • Ability to understand the study and give informed consent
  • Enrollment in the health insurance scheme
Not Eligible

You will not qualify if you...

  • Pregnancy
  • Previous participation in a facial rehabilitation program
  • Patient under legal protection
  • Unable to provide clear information or consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - 2 weeks

Participants undergo a personalized rehabilitation program of facial involvement in systemic sclerosis or receive routine care with a standard prescription for facial rehabilitation.

3 sessions of 2 hours of facial rehabilitation in hospital over 2 weeks plus facial self-rehabilitation sessions at home

Trial Site Locations

Total: 1 location

1

Hôpitaux Universitaire de Strasbourg

Strasbourg, Bas-Rhin, France, 67300

Actively Recruiting

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Research Team

E

Emmanuel CHATELUS, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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