<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03786913</url>
  </required_header>
  <id_info>
    <org_study_id>BenhaU122018</org_study_id>
    <nct_id>NCT03786913</nct_id>
  </id_info>
  <brief_title>Quantitative Muscle Ultrasound as a Marker of Progression in Children With Muscular Diseases</brief_title>
  <official_title>Quantitative Muscle Ultrasound as a Monitoring Tool of Disease Progression in Children With Inflammatory Myositis and Duchenne Muscular Dystrophy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Benha University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Benha University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of our study is to Assess skeletal muscle structural status in children with&#xD;
      inflammatory myositis and Duchenne muscular dystrophy using musculoskeletal ultrasound and to&#xD;
      perform a longitudinal follow up of these changes over 2 years and to assess the relation&#xD;
      between these findings with clinical parameters, functional scales, biochemical and&#xD;
      electromyographic tests.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will be carried out on two groups:&#xD;
&#xD;
      • Group (I): fifty children diagnosed to have duchenne muscular dystrophy and inflammatory&#xD;
      myositis.&#xD;
&#xD;
      Group (II): including 20 healthy children matching age and sex as control group.&#xD;
&#xD;
      patients will be subjected to&#xD;
&#xD;
      (A) Clinical evaluation&#xD;
&#xD;
        1. Complete history taking.&#xD;
&#xD;
        2. Thorough clinical examination.&#xD;
&#xD;
        3. Body mass index (BMI) assessment.&#xD;
&#xD;
        4. Quantitative muscle strength tests&#xD;
&#xD;
        5. Functional grading&#xD;
&#xD;
        6. Childhood Myositis Assessment Scale. 7 (B) Laboratory assessment:&#xD;
&#xD;
      All patients will be subjected to the following measurements:&#xD;
&#xD;
        1. Serum creatine kinase levels (CK).&#xD;
&#xD;
        2. Serum Lactate dehydrogenase levels&#xD;
&#xD;
        3. Serum of Liver enzymes (SGOT&amp; SGPT) levels.&#xD;
&#xD;
      (C) Electromyographic (EMG) assessment:&#xD;
&#xD;
      (D) Musculoskeletal ultrasound assessment (E) Statistical analysis&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 8, 2016</start_date>
  <completion_date type="Actual">February 2, 2019</completion_date>
  <primary_completion_date type="Actual">February 2, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Kendall's manual muscle testing</measure>
    <time_frame>24 months</time_frame>
    <description>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)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Childhood myositis assessment scale</measure>
    <time_frame>24 months</time_frame>
    <description>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)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum creatine kinase (CK) levels</measure>
    <time_frame>24 months</time_frame>
    <description>CK measured in U/L using ELISA</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum Lactate dehydrogenase (LDH) levels</measure>
    <time_frame>24 months</time_frame>
    <description>CK measured in IU/L using ELISA</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Aspartate aminotransferase (AST)</measure>
    <time_frame>24 MONTHS</time_frame>
    <description>AST measured in U/L using ELISA</description>
  </primary_outcome>
  <primary_outcome>
    <measure>alanine aminotransferase (ALT)</measure>
    <time_frame>24 months</time_frame>
    <description>ALT measured in U/L using ELISA</description>
  </primary_outcome>
  <primary_outcome>
    <measure>motor unit potential (MUP) duration</measure>
    <time_frame>24 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>motor unit peak-to-peak amplitude</measure>
    <time_frame>24 months</time_frame>
    <description>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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>motor unit area to amplitude ratio (AAR)</measure>
    <time_frame>24 months</time_frame>
    <description>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 .</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">48</enrollment>
  <condition>Inflammatory Myopathy</condition>
  <condition>Duchenne Muscular Dystrophy</condition>
  <arm_group>
    <arm_group_label>children with muscle disease</arm_group_label>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <description>20 healthy children matching age and sex as control group in whom Quantitative muscle ultrasound measurement will be performed at baseline</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Quantitative muscle ultrasound measurements</intervention_name>
    <description>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.</description>
    <arm_group_label>children with muscle disease</arm_group_label>
    <arm_group_label>control group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        the study will be performed on 2 groups Group (I): fifty children diagnosed to have&#xD;
        inflammatory myositis and Duchenne muscular dystrophy Group (II): including 20 healthy&#xD;
        children matching age and sex as control group.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  children with Duchenne muscular dystrophy (DMD). Diagnosis with DMD was established&#xD;
             according to DMD diagnostic criteria (Jennekens et al., 1991).&#xD;
&#xD;
          -  children with juvenile dermatomyositis (JDM) according to Bohan and Peter diagnostic&#xD;
             criteria ( (Bohan and Peter, 1975).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with age less than 2 years were excluded from the study due to inability to&#xD;
             perform manual muscle testing and functional scales.&#xD;
&#xD;
          -  If no final diagnosis could be established.&#xD;
&#xD;
          -  The presence of a concomitant illness that may result in peripheral neuropathy or&#xD;
             myopathy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Waleed Hassan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Benha university- Qaluibya- Egypt</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Benha University Hospital</name>
      <address>
        <city>Banhā</city>
        <state>Qalubiya</state>
        <zip>13518</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>December 21, 2018</study_first_submitted>
  <study_first_submitted_qc>December 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>February 7, 2019</last_update_submitted>
  <last_update_submitted_qc>February 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Benha University</investigator_affiliation>
    <investigator_full_name>Waleed Ahmed Salaheldeen Hassan</investigator_full_name>
    <investigator_title>Assistant professor</investigator_title>
  </responsible_party>
  <keyword>Inflammatory myositis</keyword>
  <keyword>Duchenne Muscular Dystrophy</keyword>
  <keyword>Musculoskeletal ultrasound</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscular Dystrophies</mesh_term>
    <mesh_term>Muscular Dystrophy, Duchenne</mesh_term>
    <mesh_term>Myositis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03786913
org study id: BenhaU122018
nct id: NCT03786913
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
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
observational model: Cohort
time perspective: Prospective
measure: Kendall's manual muscle testing
time frame: 24 months
description: 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)
measure: Childhood myositis assessment scale
time frame: 24 months
description: 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)
measure: Serum creatine kinase (CK) levels
time frame: 24 months
description: CK measured in U/L using ELISA
measure: Serum Lactate dehydrogenase (LDH) levels
time frame: 24 months
description: CK measured in IU/L using ELISA
measure: Aspartate aminotransferase (AST)
time frame: 24 MONTHS
description: AST measured in U/L using ELISA
measure: alanine aminotransferase (ALT)
time frame: 24 months
description: ALT measured in U/L using ELISA
measure: motor unit potential (MUP) duration
time frame: 24 months
description: 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.
measure: motor unit peak-to-peak amplitude
time frame: 24 months
description: 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
measure: motor unit area to amplitude ratio (AAR)
time frame: 24 months
description: 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 .
arm group label: 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.
arm group label: control group
description: 20 healthy children matching age and sex as control group in whom Quantitative muscle ultrasound measurement will be performed at baseline
intervention type: Diagnostic Test
intervention name: Quantitative muscle ultrasound measurements
description: 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.
arm group label: children with muscle disease
arm group label: control group
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 2 Years
maximum age: 16 Years
last name: Waleed Hassan, MD
role: Principal Investigator
affiliation: Benha university- Qaluibya- Egypt
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Benha University
investigator full name: Waleed Ahmed Salaheldeen Hassan
investigator title: Assistant professor
mesh term: Muscular Dystrophies
mesh term: Muscular Dystrophy, Duchenne
mesh term: Myositis
sharing ipd: No