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

NCT ID: NCT03786913

Last Updated: 2019-02-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 48 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-03-08
• Study Completion Date: 2019-02-02

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

Conditions

Inflammatory Myopathy; Duchenne Muscular Dystrophy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

children with muscle disease

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.

Quantitative muscle ultrasound measurements

Intervention Type: 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.

control group

20 healthy children matching age and sex as control group in whom Quantitative muscle ultrasound measurement will be performed at baseline

Quantitative muscle ultrasound measurements

Intervention Type: 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.

Interventions

Quantitative muscle ultrasound measurements

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.

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Benha University

OTHER

Sponsor Role: lead

Responsible Party

Waleed Ahmed Salaheldeen Hassan

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Waleed Hassan, MD

Role: PRINCIPAL_INVESTIGATOR

Benha university- Qaluibya- Egypt

Locations

Benha University Hospital

Banhā, Qalyubia Governorate, Egypt

Countries

Egypt

Other Identifiers

BenhaU122018

Identifier Type: -

Identifier Source: org_study_id