NCT02742298已完成不适用
Electrical Impedance Myography and Muscle Ultrasound: Longitudinal Measures in Pompe Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Percent change in muscle ultrasound echointensity as compared to baseline
研究概览
简要总结
Study Objectives:
- Determine the correlation between quantitative muscle ultrasound (QMUS), electrical impedance myography (EIM) and currently accepted measures of physical function.
- Determine the reliability of EIM measures performed in the home through use of a hand held device.
- Determine if QMUS and EIM can detect pre-clinical changes in Pompe disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- Single (Investigator)
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
- •Genetically confirmed diagnosis of Pompe disease.
排除标准
- •Age <18 years
- •Inability to provide informed consent.
结局指标
主要结局
Percent change in muscle ultrasound echointensity as compared to baseline
时间窗: Baseline, 1-2 years
Percent change in muscle electrical impedance myography as compared to baseline
时间窗: Baseline, 1-2 years
次要结局
- Inter-rater reliability of muscle ultrasound and electrical impedance myography measures(1-2 years)
研究者
研究点 (2)
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