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

NCT05177380 | Unknown

• 2 other identifiers: 80722020-A03314-35
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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

Keywords

Face; Facial involvement; Rehabilitation; Systemic sclerosis

Outcome Measures

Primary Outcomes (1)

• Mouth Handicap In Systemic Sclerosis (MHISS) score

  A 12-item questionnaire specifically quantifying mouth disability in systemic sclerosis

  Week 6

Secondary Outcomes (18)

• Mouth Handicap In Systemic Sclerosis (MHISS) score

  Week 2

• Mouth Handicap In Systemic Sclerosis (MHISS) score

  Week12

• Interincisal distance measurement

  Week 6

• Interincisal distance measurement

  Week 12

• Rodnan skin score on the face

  Week 6

Study Arms (2)

Personalized rehabilitation program of facial involvement in systemic sclerosis

EXPERIMENTAL

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

Routine care

OTHER

Delivery of a standard prescription for facial rehabilitation

Other: Delivery of a standard prescription for facial rehabilitation

Interventions

Personalized rehabilitation program of facial involvement in systemic sclerosis PROCEDURE

Personalized rehabilitation program of facial involvement in systemic sclerosis

Personalized rehabilitation program of facial involvement in systemic sclerosis

Delivery of a standard prescription for facial rehabilitation OTHER

Delivery of a standard prescription for facial rehabilitation

Routine care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy
• Previous participation in a rehabilitation program of facial involvement
• Patient under legal protection
• Impossibility to give clear information of subject

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

MeSH Terms

Conditions

Scleroderma, Systemic; Facies

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Emmanuel CHATELUS, MD

CONTACT

+33 3 88 12 71 40; emmanuel.chatelus@chru-strasbourg.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2021
• First Posted: January 4, 2022
• Study Start: September 1, 2022
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: August 18, 2022

Record last verified: 2022-08