Clinical trial NCT03786913: Quantitative Muscle Ultrasound as a Marker of Progression in Children With Muscular Diseases
Official title: Quantitative Muscle Ultrasound as a Monitoring Tool of Disease Progression in Children With Inflammatory Myositis and Duchenne Muscular Dystrophy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Myopathy
Duchenne Muscular Dystrophy
Keywords: Inflammatory myositis
Duchenne Muscular Dystrophy
Musculoskeletal ultrasound
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2018-12-26
Enrollment: 48
Sex: ALL
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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

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.

Primary outcomes:
measure: Kendall's manual muscle testing
timeFrame: 24 months
measure: Childhood myositis assessment scale
timeFrame: 24 months
measure: Serum creatine kinase (CK) levels
timeFrame: 24 months
measure: Serum Lactate dehydrogenase (LDH) levels
timeFrame: 24 months
measure: Aspartate aminotransferase (AST)
timeFrame: 24 MONTHS
measure: alanine aminotransferase (ALT)
timeFrame: 24 months
measure: motor unit potential (MUP) duration
timeFrame: 24 months
measure: motor unit peak-to-peak amplitude
timeFrame: 24 months
measure: motor unit area to amplitude ratio (AAR)
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Benha University Hospital
state: Qalubiya
Study officials:
affiliation: Benha university- Qaluibya- Egypt
name: Waleed Hassan, MD
role: PRINCIPAL_INVESTIGATOR
References: