NCT05177380

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University Hospital, Strasbourg, France · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	Personalized rehabilitation program of facial involvement in systemic sclerosis	Personalized rehabilitation program of facial involvement in systemic sclerosis
OTHER	Delivery of a standard prescription for facial rehabilitation	Delivery of a standard prescription for facial rehabilitation

Timeline

• Start date: 2022-09-01
• Primary completion: 2024-04-01
• Completion: 2024-04-01
• First posted: 2022-01-04
• Last updated: 2022-08-18