Quantitative Muscle Ultrasound as a Monitoring Tool of Disease Progression in Children With Inflammatory Myositis and Duchenne Muscular Dystrophy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- motor unit peak-to-peak amplitude
研究概览
简要总结
The aim of our study is to Assess skeletal muscle structural status in children with inflammatory myositis and Duchenne muscular dystrophy using musculoskeletal ultrasound and to perform a longitudinal follow up of these changes over 2 years and to assess the relation between these findings with clinical parameters, functional scales, biochemical and electromyographic tests.
详细描述
This study will be carried out on two groups:
• Group (I): fifty children diagnosed to have duchenne muscular dystrophy and inflammatory myositis.
Group (II): including 20 healthy children matching age and sex as control group.
patients will be subjected to
(A) Clinical evaluation
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
- 2 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children with Duchenne muscular dystrophy (DMD). Diagnosis with DMD was established according to DMD diagnostic criteria (Jennekens et al., 1991).
- •children with juvenile dermatomyositis (JDM) according to Bohan and Peter diagnostic criteria ( (Bohan and Peter, 1975).
排除标准
- •Patients with age less than 2 years were excluded from the study due to inability to perform manual muscle testing and functional scales.
- •If no final diagnosis could be established.
- •The presence of a concomitant illness that may result in peripheral neuropathy or myopathy.
结局指标
主要结局
motor unit peak-to-peak amplitude
时间窗: 24 months
quantitative electromyography (QEMG) in the most affected rectus femoris and biceps brachii muscles will be performed and The motor unit potentials will be reviewed offline for the needle-detected EMG signals will be analyzed by the device software for the peak-to-peak amplitude measured in microvolt
motor unit area to amplitude ratio (AAR)
时间窗: 24 months
quantitative electromyography (QEMG) in the most affected rectus femoris and biceps brachii muscles will be performed and The motor unit potentials will be reviewed offline for the needle-detected EMG signals will be analyzed by the device software for the motor unit AAR .
Serum creatine kinase (CK) levels
时间窗: 24 months
CK measured in U/L using ELISA
Serum Lactate dehydrogenase (LDH) levels
时间窗: 24 months
CK measured in IU/L using ELISA
Aspartate aminotransferase (AST)
时间窗: 24 MONTHS
AST measured in U/L using ELISA
alanine aminotransferase (ALT)
时间窗: 24 months
ALT measured in U/L using ELISA
Kendall's manual muscle testing
时间窗: 24 months
Kendall's 0 -10 point scale measures strength of each muscle group score 0 is the weakest (worst) and 10 is the strongest (best). The following muscles were tested bilaterally: the biceps brachii muscle (BB), the forearm flexors (FF), the rectus femoris muscle (RF), the tibialis anterior muscle (TA)
Childhood myositis assessment scale
时间窗: 24 months
used to assess the severity of muscle involvement in children with dermatomyositis. The scores for the 14 items are summated to give a total score ranging from 0 (worst) to 52 (best)
motor unit potential (MUP) duration
时间窗: 24 months
quantitative electromyography (QEMG) in the most affected rectus femoris and biceps brachii muscles will be performed and The motor unit potentials will be reviewed offline for the needle-detected EMG signals will be analyzed by the device software for the MUP duration measured in milliseconds.
次要结局
未报告次要终点
研究者
Waleed Ahmed Salaheldeen Hassan
Assistant professor
Benha University