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

NCT ID: NCT05177380

Last Updated: 2022-08-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-30
• Study Completion Date: 2024-04-30

Brief 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.

Conditions

Systemic Sclerosis; Face; Facial Involvement; Rehabilitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Personalized rehabilitation program of facial involvement in systemic sclerosis

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

Group Type: EXPERIMENTAL

Personalized rehabilitation program of facial involvement in systemic sclerosis

Intervention Type: PROCEDURE

Personalized rehabilitation program of facial involvement in systemic sclerosis

Routine care

Delivery of a standard prescription for facial rehabilitation

Group Type: OTHER

Delivery of a standard prescription for facial rehabilitation

Intervention Type: OTHER

Delivery of a standard prescription for facial rehabilitation

Interventions

Personalized rehabilitation program of facial involvement in systemic sclerosis

Personalized rehabilitation program of facial involvement in systemic sclerosis

Intervention Type: PROCEDURE

Delivery of a standard prescription for facial rehabilitation

Delivery of a standard prescription for facial rehabilitation

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Strasbourg, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Emmanuel CHATELUS, MD

Role: CONTACT

emmanuel.chatelus@chru-strasbourg.fr

+33 3 88 12 71 40

Other Identifiers

8072

Identifier Type: -

Identifier Source: org_study_id

2020-A03314-35

Identifier Type: OTHER

Identifier Source: secondary_id