Efficacy of a Personalized Rehabilitation Program of Facial Involvement in Systemic Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Mouth Handicap In Systemic Sclerosis (MHISS) score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Pregnancy
- •Previous participation in a rehabilitation program of facial involvement
- •Patient under legal protection
- •Impossibility to give clear information of subject
研究组 & 干预措施
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
干预措施: Personalized rehabilitation program of facial involvement in systemic sclerosis (Procedure)
Routine care
Delivery of a standard prescription for facial rehabilitation
干预措施: Delivery of a standard prescription for facial rehabilitation (Other)
结局指标
主要结局
Mouth Handicap In Systemic Sclerosis (MHISS) score
时间窗: Week 6
A 12-item questionnaire specifically quantifying mouth disability in systemic sclerosis
次要结局
- Rodnan skin score on the face(Week 12)
- HAQ questionnaire(Week 12)
- Total number of rehabilitation sessions(Week 12)
- Total duration of rehabilitation sessions(Week 12)
- Mouth Handicap In Systemic Sclerosis (MHISS) score(Week12)
- Interincisal distance measurement(Week 12)
- Visual Analog Scale (VAS) for pain(Week12)
- Weight(Week 12)
- SF12 questionnaire (12-item Short Form Survey)(Week 12)