NCT02340923已完成不适用
A Device for Rapid, Painless, Bedside Muscle Evaluation of Children
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Skulpt, Inc.
- 入组人数
- 327
- 试验地点
- 5
- 主要终点
- Electrical Impedance Myography Measurements
研究概览
简要总结
The purpose of this protocol is to perform Electrical Impedance Myography (EIM) testing on healthy children and children with duchenne muscular dystrophy so as to develop a new, convenient tool for the office based assessment of children with a wide variety of neuromuscular conditions.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Genetic or histopathologic diagnosis of duchenne muscular dystrophy, or signs and symptoms of DMD and genetic or histopathologic diagnosis in a family member.
排除标准
- •Age over 18
- •Presence of a superimposed neuromuscular or other medical condition that substantially impacts the individual's health or ability to cooperate.
结局指标
主要结局
Electrical Impedance Myography Measurements
时间窗: Baseline (all subjects) & 3 months, 6 months, 1 year for returning subjects only
Up to 11 muscles will be measured using EIM technology. These muscles include: Right Lateral Deltoid, Right Biceps, Right Triceps, Right Wrist Flexors, Right Wrist Extensors, Right Vastus Lateralis, Right Tibialis Anterior, Right Gastrocnemius, Right Gluteus Medius, Right Biceps Femoris, and Right Thoracic Parapinal.
次要结局
未报告次要终点
研究者
研究点 (5)
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