An observational study in Inflammatory Myopathy and Duchenne Muscular Dystrophy, sponsored by Benha University. Completed at 1 site in Egypt. Open to participants aged 2 Years to 16 Years. Per ClinicalTrials.gov, last updated 2019-02-08.
Sponsored by Benha University · Observational
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.
This study will be carried out on two groups:
Group (II): including 20 healthy children matching age and sex as control group.
patients will be subjected to
(A) Clinical evaluation
All patients will be subjected to the following measurements:
(C) Electromyographic (EMG) assessment:
(D) Musculoskeletal ultrasound assessment (E) Statistical analysis
548 studies on the registry are indexed under Muscular Dystrophies; 89 are open to participants now.
This study's enrollment of 48 is below the median of 69 across 179 observational studies indexed under Muscular Dystrophies.
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the study will be performed on 2 groups Group (I): fifty children diagnosed to have inflammatory myositis and Duchenne muscular dystrophy Group (II): including 20 healthy children matching age and sex as control group.
Exclusion Criteria:
fifty children diagnosed to have inflammatory myositis or Duchenne muscular dystrophy in whom Quantitative muscle ultrasound measurements will be performed .The captured images will be analyzed for echo intensity by means of computer-assisted grayscale histogram analysis at baseline and after 24 months.
Diagnostic Test: Quantitative muscle ultrasound measurements
20 healthy children matching age and sex as control group in whom Quantitative muscle ultrasound measurement will be performed at baseline
Diagnostic Test: Quantitative muscle ultrasound measurements
Quantitative ultrasound measurements will be performed to biceps, forearm flexors, quadriceps and tibialis anterior according to a standard protocol; for each muscle three consecutive measurements will be made to minimize variation in echo intensity during analysis .The captured images will be analyzed offline for echo intensity by means of computer-assisted grayscale histogram analysis.
Kendall's manual muscle testing
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)
Time frame: 24 months
Childhood myositis assessment scale
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)
Time frame: 24 months
Serum creatine kinase (CK) levels
CK measured in U/L using ELISA
Time frame: 24 months
Serum Lactate dehydrogenase (LDH) levels
CK measured in IU/L using ELISA
Time frame: 24 months
Aspartate aminotransferase (AST)
AST measured in U/L using ELISA
Time frame: 24 MONTHS
alanine aminotransferase (ALT)
ALT measured in U/L using ELISA
Time frame: 24 months
motor unit potential (MUP) duration
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.
Time frame: 24 months
motor unit peak-to-peak amplitude
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
Time frame: 24 months
motor unit area to amplitude ratio (AAR)
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 .
Time frame: 24 months
Plan to share: No
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This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Benha University