Clinical Trials Directory

Trials / Completed

CompletedNCT03786913

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

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

Status
Completed
Phase
Study type
Observational
Enrollment
48 (actual)
Sponsor
Benha University · Academic / Other
Sex
All
Age
2 Years – 16 Years
Healthy volunteers

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

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTQuantitative muscle ultrasound measurementsQuantitative 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.

Timeline

Start date
2016-03-08
Primary completion
2019-02-02
Completion
2019-02-02
First posted
2018-12-26
Last updated
2019-02-08

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT03786913. Inclusion in this directory is not an endorsement.