Systemic Sclerosis (SSc) Clinical Trials

Find Systemic Sclerosis (SSc) Clinical Trials Near You

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

Status: Recruiting
Location: See location...
Intervention Type: Other, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Hôpitaux Universitaire de Strasbourg
RECRUITING
Strasbourg
Contact Information
Primary
Emmanuel CHATELUS, MD
emmanuel.chatelus@chru-strasbourg.fr
+33 3 88 12 71 40
Time Frame
Start Date: 2022-10-13
Estimated Completion Date: 2029-12
Participants
Target number of participants: 60
Treatments
Experimental: 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
Other: Routine care
Delivery of a standard prescription for facial rehabilitation
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Strasbourg, France

This content was sourced from clinicaltrials.gov