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NCT05177380
Efficacy of a Personalized Rehabilitation Program of Facial Involvement in Systemic Sclerosis
Conditions: Systemic Sclerosis, Face, Facial Involvement, Rehabilitation
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 60
Sponsor: University Hospital, Strasbourg, France
Location: Hôpitaux Universitaire de Strasbourg Strasbourg Bas-Rhin
Summary
Systemic sclerosis is a rare autoimmune disorder characterized by microangiopathy, activation of the immune system, and sclerosis of tissues including the skin. Facial involvement is frequent and disabling. It causes significant functional and aesthetic discomfort, and a major deterioration in quality of life. It results in a loss of suppleness of the skin and subcutaneous tissues, dysfunction of the temporomandibular joint, peribuccal rhagades, microstomia, and dry mouth causing difficulties in mouth opening, feeding, dental care, and weight loss.
Facial involvement in systemic sclerosis can be assessed using the Mouth Handicap in Systemic Sclerosis (MHISS) score, a validated patient questionnaire assessing the functional and aesthetic consequences of systemic sclerosis on the face.
Although common and disabling, facial involvement is underestimated and poorly managed. Immunosuppressive and/or anti-fibrosis drugs are not very effective. Facial rehabilitation could significantly improve the mouth handicap but facial rehabilitation is not currently performed in standard care in systemic sclerosis patients.
The aim of the study is to evaluate the efficacy of a personalized rehabilitation program vs standard care in facial involvement of systemic sclerosis patients.
Eligibility Criteria
Inclusion Criteria:
* Age ≥ 18 yo
* Systemic sclerosis according to the 2013 ACR/EULAR (American College of Rheumatology) classification criteria
* Systemic sclerosis with facial involvement defined by a MHISS score \> 6
* Immunosuppressive and/or anti-fibrosis treatment stable for at least 1 month
* Subject able to understand the objectives and risks of research and to give informed consent
* Subject enrolment in the health insurance scheme
Exclusion Criteria:
* Pregnancy
* Previous participation in a rehabilitation program of facial involvement
* Patient under legal protection
* Impossibility to give clear information of subject
Source: ClinicalTrials.gov (NCT05177380). StuddyBuddy aggregates publicly available trial information.