Disease Progression in Facioscapulohumeral Muscular Dystrophy - 1 Year MRI Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Fat infiltration
研究概览
简要总结
An investigation of disease progression in adult danish patients with facioscapulohumeral muscular dystrophy. The disease progression is followed for a year with two test-days, including functional muscle tests and a MRI scan of muscles in the back and legs.
详细描述
A cohort of adult danish patients with facioscapulohumeral muscular dystrophy is invited to perform a MRI scan to describe the relation between backpain and disease affection in back muscles. After one year they are re-invited to perform another MRI scan to follow the disease progression.
The MRI scan is done to measure the quantity and quality of the muscles in the back, thigh and calf. Further, investigators investigate the muscle function by measuring of muscle strength in legs and in the back together with three functional tests. A walking test (6MWT), a stair test (14SST), and a chair test (5-TSTST). Self-assessment of back pain is measured by a standardized questionnaire about backpain.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with FSHD type 1
排除标准
- •Pregnant or breastfeeding women.
- •Patients with claustrophobia.
- •Patients with implanted metallic parts in the body.
结局指标
主要结局
Fat infiltration
时间窗: 1 year
Change in the distribution of fat infiltration in back, thigh and calves muscles seen at the MRI images.
次要结局
- Back pain(1 year)
- Muscle strength(1 year)
- Muscle structure(1 year)
- Muscle function(1 year)
研究者
Grete Andersen, MD
Medical doctor
Rigshospitalet, Denmark