Efficacy of a Personalized Rehabilitation Program of Facial Involvement in Systemic Sclerosis (PREVISS)

University Hospital, Strasbourg, France

Status: Not yet enrolling

Conditions: Rehabilitation; Face; Systemic Sclerosis; Facial Involvement

Treatments: Procedure: Personalized rehabilitation program of facial involvement in systemic sclerosis; Other: Delivery of a standard prescription for facial rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT05177380

2020-A03314-35 (Other Identifier)

8072

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Personalized rehabilitation program of facial involvement in systemic sclerosis

Experimental group

Description:

3 sessions of 2 hours of facial rehabilitation in hospital over 2 weeks including: * Physiotherapy with facial and endo-oral massages, self-massages, active and passive exercises of the face and mouth, tongue exercises * Speech therapy with mobilization of the orofacial sphere applied to swallowing and speech difficulties * Individual workshop on the theme of dry mouth, dry mouth, swallowing disorders, and oral care * Individual therapeutic makeup workshop * A motivational interview * A patient notebook with a personalized protocol for self-rehabilitation of the face * A video tutorial for self-rehabilitation of the face Facial self-rehabilitation sessions at home

Treatment:

Procedure: Personalized rehabilitation program of facial involvement in systemic sclerosis

Routine care

Other group

Description:

Delivery of a standard prescription for facial rehabilitation

Treatment:

Other: Delivery of a standard prescription for facial rehabilitation