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

Study Overview
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Brief Summary
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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.

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

Conditions
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Systemic Sclerosis, Face, Facial Involvement, Rehabilitation

Intervention / Treatment
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* Procedure: Personalized rehabilitation program of facial involvement in systemic sclerosis
* Other: Delivery of a standard prescription for facial rehabilitation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Personalized rehabilitation program of facial involvement in systemic sclerosis<br>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 | Procedure: Personalized rehabilitation program of facial involvement in systemic sclerosis<br>* Personalized rehabilitation program of facial involvement in systemic sclerosis<br>|
| Other: Routine care<br>Delivery of a standard prescription for facial rehabilitation | Other: Delivery of a standard prescription for facial rehabilitation<br>* Delivery of a standard prescription for facial rehabilitation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mouth Handicap In Systemic Sclerosis (MHISS) score | A 12-item questionnaire specifically quantifying mouth disability in systemic sclerosis | Week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mouth Handicap In Systemic Sclerosis (MHISS) score | A 12-item questionnaire specifically quantifying mouth disability in systemic sclerosis | Week 2 | 
| Mouth Handicap In Systemic Sclerosis (MHISS) score | A 12-item questionnaire specifically quantifying mouth disability in systemic sclerosis | Week12 | 
| Interincisal distance measurement | Interincisal distance measurement in mm | Week 6 | 
| Interincisal distance measurement | Interincisal distance measurement in mm | Week 12 | 
| Rodnan skin score on the face | a measure of skin thickness | Week 6 | 
| Rodnan skin score on the face | a measure of skin thickness | Week 12 | 
| Visual Analog Scale (VAS) for pain |  | Week 2 | 
| Visual Analog Scale (VAS) for pain |  | Week 6 | 
| Visual Analog Scale (VAS) for pain |  | Week12 | 
| HAQ questionnaire | Health Assessment Questionnaire | Week 6 | 
| HAQ questionnaire | Health Assessment Questionnaire | Week 12 | 
| SF12 questionnaire (12-item Short Form Survey) | a 12-item general health questionnaire | Week 6 | 
| SF12 questionnaire (12-item Short Form Survey) | a 12-item general health questionnaire | Week 12 | 
| Weight | Weight in kg | Week 12 | 
| Total number of rehabilitation sessions |  | Week 6 | 
| Total duration of rehabilitation sessions |  | Week 6 | 
| Total number of rehabilitation sessions |  | Week 12 | 
| Total duration of rehabilitation sessions |  | Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Face, Facial involvement, Rehabilitation, Systemic sclerosis