Efficiency Clinical Study of NOVATEX MEDICAL Compression Garments in Patients With Ehlers-Danlos Syndrome
试验速览
- 阶段
- 不适用
- 入组人数
- 106
- 试验地点
- 20
- 主要终点
- Improvement of Functional Independence Measure (FIM) scale from 4 months at 8 months
研究概览
简要总结
Objective of this study is to assess the efficiency of NOVATEX MEDICAL compression garments in patients with an Ehlers-Danlos syndrome (EDS).
To answer this objectif a comparison before/after use of compression garments will be performed for all patients.
详细描述
Inclusion period: 1 year Follow-up period: 26 months Study period : 38 months
Patient visits will be organized as follow:
- V0: first visit at inclusion, clinical evaluation
- V1: 4 months after inclusion, clinical evaluation without compression garments and presure garments prescription
- V2: 8 months after inclusion, clinical evaluation with compression garments
- V3: 14 months after inclusion, clinical evaluation with compression garments
- V4: 20 months after inclusion, clinical evaluation with compression garments
- V5: 26 months after inclusion, clinical evaluation with compression garments
Only the first two visits are specific to the study to be able to compare before and after the use of compression garments. Next visits are the usual visits (every 6 months) for the use of compression garments in patients with an EDS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient between 15 and 60 years old
- •Ehlers-Danlos Syndrome type: " classical ", " classical-like ", " hypermobile ", " arthrochalasia ", " kyphoscoliotic ", " musculocontractural " ou " myopathic ", as defined in the new international EDS classification 2017
- •Patient who have never used compression garments
- •Patient for whom compression garments will be prescribed at 4 months
- •Patient who have dated and signed a consent form
- •Patient who have understood the study
- •Patient who are affiliated to French social health insurance system and/or in compliance with the recommendations of the national law in force relating to biomedical research
排除标准
- •patient under guardianship or enabled to complete questionnaires
- •pregnant or breastfeeding woman
- •patient who presents allergy to one of compression garments components
- •patient with a current medical history who promotes postural disorders
- •patient with an asymptomatic "Hypermobile Sprectrum Disorder" type of EDS as defined in the new international EDS classification 2017
- •patient with a current or recent (<3months) participation in another investigational study
结局指标
主要结局
Improvement of Functional Independence Measure (FIM) scale from 4 months at 8 months
时间窗: month 4, month 8
Functional Independence Measure (FIM) is an 18- Item of physical, psychological and social function. The FIM uses the level of assistance an individual needs to grade the functional status of a person. For each item, disability level is coded from 1 (Total Assistance or not Testable) to 7 (Complete Independence) A total score is calculated using an addition of all items. Thus, score ranges are \[18;126\]. More the score is high, better is the independence. The proportion of patients who present an improvement of 10% of the FIM score between 4 months and 8 months will be calculated.
次要结局
- Patient characteristics(Inclusion)
- Evolution of Pain (before and after compression garments using)(Inclusion, month 4, month 8, month 14, month 20, month 26)
- Evolution of Tiredness from inclusion at each visit (4 months, 8 months, 14 months, 20 months, 26 months)(Inclusion, month 4, month 8, month 14, month 20, month 26)
- Relative improvement of Functional Independence Measure (FIM) scale at 8 months(month 4, month 8)
- Evolution of Anxiety and depression from inclusion at each visit (4 months, 8 months, 14 months, 20 months, 26 months)(Inclusion, month 4, month 8, month 14, month 20, month 26)
- Evolution of Functional Independence Measure (FIM) scale at long-term from inclusion at 14 months, 20 months and 26 months(Inclusion, month 14, month 20, month 26)
- Evolution of Quality of Life from inclusion at each visit (4 months, 8 months, 14 months, 20 months, 26 months)(Inclusion, month 4, month 8, month 14, month 20, month 26)
- Evolution of Compliance(Month 8, month 14, month 20, month 26)
- Evolution of the Use of concomitant medication from inclusion at each visit (4 months, 8 months, 14 months, 20 months, 26 months)(Inclusion, month 4, month 8, month 14, month 20, month 26)
- Compression garments safety(month 26)
- Evolution of Patient satisfaction(month 8, month 14, month 20, month 26)