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

B

Benha University

Status

Completed

Conditions

Inflammatory Myopathy
Duchenne Muscular Dystrophy

Treatments

Diagnostic Test: Quantitative muscle ultrasound measurements

Study type

Observational

Funder types

Other

Identifiers

NCT03786913
BenhaU122018

Details and patient eligibility

About

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.

Full 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

Enrollment

48 patients

Sex

All

Ages

2 to 16 years old

Volunteers

No Healthy Volunteers

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.

Trial design

48 participants in 2 patient groups

children with muscle disease
Description:
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.
Treatment:
Diagnostic Test: Quantitative muscle ultrasound measurements
control group
Description:
20 healthy children matching age and sex as control group in whom Quantitative muscle ultrasound measurement will be performed at baseline
Treatment:
Diagnostic Test: Quantitative muscle ultrasound measurements

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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