Hand Function Impairment in Systemic Sclerosis: Outcomes, Mechanisms and Experience (HANDSOME) Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- UMC Utrecht
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Determination of risk factors for hand function impairment in systemic sclerosis (SSc) patients with early disease, very early disease and established hand impairment (contractures) at 2 years follow-up
研究概览
简要总结
Almost 90% of systemic sclerosis (SSc) patients experience hand function limitation, which leads to impaired daily functioning and work participation. An important cause of impaired hand function are contractures of the hand, which are reported in up to a half of patients. With this longitudinal cohort study in patients with SSc and VEDOSS (very early diagnosis of systemic sclerosis) the investigators aim to gain more insight into processes involved in hand function impairment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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 years
排除标准
- •Patients with diabetic cheiroarthropathy and Dupuytren's disease, based on expert opinion
研究组 & 干预措施
VEDOSS
defined as RP, presence of SSc specific autoantibodies (ACA, ATA, ARA), puffy fingers and abnormal nailfold capillaroscopy (giant capillaries or capillary loss with or without haemorrhages), but not fulfilling the EULAR-ACR 2013 classification criteria for SSc
干预措施: Imaging, blood samples, fuctional tests and physical examination (Diagnostic Test)
SSc with disease duration of < 4 years without hand contractures
干预措施: Imaging, blood samples, fuctional tests and physical examination (Diagnostic Test)
SSc with hand contractures
干预措施: Imaging, blood samples, fuctional tests and physical examination (Diagnostic Test)
结局指标
主要结局
Determination of risk factors for hand function impairment in systemic sclerosis (SSc) patients with early disease, very early disease and established hand impairment (contractures) at 2 years follow-up
时间窗: 2 years
次要结局
- Identify underlying mechanisms(2 years)
- - Validation of the Dutch PASTUL questionnaire(2 years)