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NCT Number: NCT03786913

Quantitative Muscle Ultrasound as a Marker of Progression in Children With Muscular Diseases

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.

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Key information

Conditions

Inflammatory Myopathy Congenital, Hereditary, and Neonatal Diseases and Abnormalities Duchenne Muscular Dystrophy Genetic Diseases, Inborn Genetic Diseases, X-Linked Muscular Diseases Muscular Disorders, Atrophic Muscular Dystrophies Muscular Dystrophy, Duchenne Musculoskeletal Diseases Myositis Nervous System Diseases Neuromuscular Diseases

Age range

2 year–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Benha University Hospital

Banhā, Qalyubia Governorate, 13518, Egypt

About this study

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

  • Complete history taking.
  • Thorough clinical examination.
  • Body mass index (BMI) assessment.
  • Quantitative muscle strength tests
  • Functional grading
  • Childhood Myositis Assessment Scale. 7 (B) Laboratory assessment:

All patients will be subjected to the following measurements:

  • Serum creatine kinase levels (CK).
  • Serum Lactate dehydrogenase levels
  • Serum of Liver enzymes (SGOT& SGPT) levels.

(C) Electromyographic (EMG) assessment:

(D) Musculoskeletal ultrasound assessment (E) Statistical analysis

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Quantitative muscle ultrasound measurements

Diagnostic Test

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.

Primary outcomes

  1. 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)

  2. 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)

  3. Serum creatine kinase (CK) levels

    Time frame: 24 months

    CK measured in U/L using ELISA

  4. Serum Lactate dehydrogenase (LDH) levels

    Time frame: 24 months

    CK measured in IU/L using ELISA

  5. Aspartate aminotransferase (AST)

    Time frame: 24 MONTHS

    AST measured in U/L using ELISA

  6. alanine aminotransferase (ALT)

    Time frame: 24 months

    ALT measured in U/L using ELISA

  7. 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.

  8. 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

  9. 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 .

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Dec 26, 2018
Registry last updated
Feb 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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