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Clinical Trials/NCT03786913
NCT03786913
Completed
Not Applicable

Quantitative Muscle Ultrasound as a Monitoring Tool of Disease Progression in Children With Inflammatory Myositis and Duchenne Muscular Dystrophy

Benha University1 site in 1 country48 target enrollmentMarch 8, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Inflammatory Myopathy
Sponsor
Benha University
Enrollment
48
Locations
1
Primary Endpoint
motor unit peak-to-peak amplitude
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

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.

Detailed Description

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 1. Complete history taking. 2. Thorough clinical examination. 3. Body mass index (BMI) assessment. 4. Quantitative muscle strength tests 5. Functional grading 6. Childhood Myositis Assessment Scale. 7 (B) Laboratory assessment: All patients will be subjected to the following measurements: 1. Serum creatine kinase levels (CK). 2. Serum Lactate dehydrogenase levels 3. Serum of Liver enzymes (SGOT\& SGPT) levels. (C) Electromyographic (EMG) assessment: (D) Musculoskeletal ultrasound assessment (E) Statistical analysis

Registry
clinicaltrials.gov
Start Date
March 8, 2016
End Date
February 2, 2019
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Waleed Ahmed Salaheldeen Hassan

Assistant professor

Benha University

Eligibility Criteria

Inclusion Criteria

  • 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).

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

motor unit peak-to-peak amplitude

Time Frame: 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)

Time Frame: 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

Time Frame: 24 months

CK measured in U/L using ELISA

Serum Lactate dehydrogenase (LDH) levels

Time Frame: 24 months

CK measured in IU/L using ELISA

Aspartate aminotransferase (AST)

Time Frame: 24 MONTHS

AST measured in U/L using ELISA

alanine aminotransferase (ALT)

Time Frame: 24 months

ALT measured in U/L using ELISA

Kendall's manual muscle testing

Time Frame: 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

Time Frame: 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

Time Frame: 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.

Study Sites (1)

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