<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/NCT03766698</url>
  </required_header>
  <id_info>
    <org_study_id>SankoUniversity</org_study_id>
    <nct_id>NCT03766698</nct_id>
  </id_info>
  <brief_title>Muscle Architecture of Lower Extremity In Multiple Sclerosis</brief_title>
  <official_title>Muscle Architecture of Lower Extremity In Multiple Sclerosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sanko University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sanko University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <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 this study was to determine the muscle architecture of the lower extremity muscles&#xD;
      (pennation angle, muscle fiber length and muscle thickness) in patients with multiple&#xD;
      sclerosis. Lower extremity muscles of patients with multiple sclerosis and healthy&#xD;
      individuals; rectus femoris, biceps femoris, tibialis anterior, gastrosoleus and&#xD;
      gastrocnemius muscles will be examined by ultrasound method.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Multiple sclerosis (MS) is characterised by complex and heterogeneous symptoms, often leading&#xD;
      to reduced quality of life and impaired functional capacity. The latter is related to reduced&#xD;
      muscle strength of predominately the lower limbs . The mechanisms underlying the observed&#xD;
      strength deficits are of muscular as well as neural origin . At the whole muscle level, a&#xD;
      number of studies have examined skeletal muscle characteristics of MS patients, with some&#xD;
      studies but not all, reporting loss of muscle mass and decreased or comparable maximal muscle&#xD;
      strength.&#xD;
&#xD;
      However, there is no study describing the features of lower extremity muscle architecture in&#xD;
      multiple sclerosis. Muscle architecture is defined as the alignment of muscle fibers with&#xD;
      respect to the axis of force. Although the diameters of the muscles of different sizes are&#xD;
      quite similar to the diameters of the fibers, the sequences of these fibers contain several&#xD;
      differences. The alignment of the muscle forming fibers has a significant effect on the force&#xD;
      of muscle formation. The parameters that determine muscle architecture characteristics are&#xD;
      the muscle fiber length, pennation angle, the physiological cross-sectional area. For each&#xD;
      muscle these parameters may differ from each other. Any type of load in the case is the&#xD;
      result of an adaptation process that results in muscle development. Muscle architecture&#xD;
      allows the macroscopic understanding and interpretation of this adaptation process.&#xD;
&#xD;
      Determining the muscle architecture of multiple sclerosis patients by ultrasound will guide&#xD;
      the rehabilitation process.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 18, 2018</start_date>
  <completion_date type="Actual">February 15, 2020</completion_date>
  <primary_completion_date type="Actual">January 18, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>Muscle Architecture Pennation Angle</measure>
    <time_frame>The evaluation will be made on the first 1 day.</time_frame>
    <description>Pennation Angle will be assesed by ultrasound imaging.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Muscle Architecture Muscle Fiber Lengh</measure>
    <time_frame>The evaluation will be made on the first 1 day.</time_frame>
    <description>Muscle Fiber Lenght will be assesed by ultrasound imaging.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Muscle Architecture Muscle Thickness</measure>
    <time_frame>The evaluation will be made on the first 1 day.</time_frame>
    <description>Muscle Thickness will be assesed by ultrasound imaging.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Muscle Strength</measure>
    <time_frame>The evaluation will be made on the first 1 day.</time_frame>
    <description>Ouadriceps, Hamstring, Gastrosoleus and Gastrocnemius muscle Strenght will be asses with digital hand-held dynamometer (Commander PowerTrack II muscle tester).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Circumference Measurement of Thigh</measure>
    <time_frame>The evaluation will be made on the first 1 day.</time_frame>
    <description>Thigh circumference will be measured with a tape measure. Thigh circumference measurement will be measured from the midline of the inguinal line and superior patella.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Circumference Measurement of shin</measure>
    <time_frame>The evaluation will be made on the first 1 day.</time_frame>
    <description>Shin circumference will be measured with a tape measure.Shin circumference measurement will be measured from the poplital line and the middle point of the achilles.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Thickness of subcutaneous fat from anterior thigh</measure>
    <time_frame>The evaluation will be made on the first 1 day.</time_frame>
    <description>Subcutaneous fat will be assesed with skinfold from anterior thigh. At the same time the thickness of subcutaneous fat will also be evaluated by ultrasound imaging.</description>
  </other_outcome>
  <other_outcome>
    <measure>Thickness of subcutaneous fat from posterior leg</measure>
    <time_frame>The evaluation will be made on the first 1 day.</time_frame>
    <description>Subcutaneous fat will be assesed with skinfold from posterior leg. At the same time the thickness of subcutaneous fat will also be evaluated by ultrasound imaging.</description>
  </other_outcome>
  <enrollment type="Actual">35</enrollment>
  <condition>Multiple Sclerosis</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Study Population consists of Multiple Sclerosis Patients and Healthy Volunteers.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-50 years old&#xD;
&#xD;
          -  Individuals who agree to be voluntary,&#xD;
&#xD;
          -  With the EDSS 4 and below&#xD;
&#xD;
          -  Without pregnancy&#xD;
&#xD;
          -  Do not receive corticosteroid treatment in the last month&#xD;
&#xD;
          -  Do not take any medicine that will affect walking in the last 1 month&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Those who refuse to volunteer,&#xD;
&#xD;
          -  EDSS over 4&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Corticosteroid therapy within 1 month&#xD;
&#xD;
          -  Any medication that will affect walking in the last 1 month&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zekiye İpek Katırcı Kırmacı</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sanko University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sanko University</name>
      <address>
        <city>Gaziantep</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/25264868</url>
    <description>Multiple Sclerosis and Skeletal Muscle</description>
  </link>
  <results_reference>
    <citation>Wens I, Dalgas U, Vandenabeele F, Krekels M, Grevendonk L, Eijnde BO. Multiple sclerosis affects skeletal muscle characteristics. PLoS One. 2014 Sep 29;9(9):e108158. doi: 10.1371/journal.pone.0108158. eCollection 2014.</citation>
    <PMID>25264868</PMID>
  </results_reference>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>December 4, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 2018</study_first_posted>
  <last_update_submitted>March 17, 2020</last_update_submitted>
  <last_update_submitted_qc>March 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sanko University</investigator_affiliation>
    <investigator_full_name>zekiye ipek katırcı kırmacı</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Multiple Sclerosis</keyword>
  <keyword>Muscle Architecture</keyword>
  <keyword>Lower extremity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Sclerosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Sharing of data information has not yet been decided.</ipd_description>
  </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/NCT03766698
org study id: SankoUniversity
nct id: NCT03766698
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study was to determine the muscle architecture of the lower extremity muscles
      (pennation angle, muscle fiber length and muscle thickness) in patients with multiple
      sclerosis. Lower extremity muscles of patients with multiple sclerosis and healthy
      individuals; rectus femoris, biceps femoris, tibialis anterior, gastrosoleus and
      gastrocnemius muscles will be examined by ultrasound method.
Multiple sclerosis (MS) is characterised by complex and heterogeneous symptoms, often leading
      to reduced quality of life and impaired functional capacity. The latter is related to reduced
      muscle strength of predominately the lower limbs . The mechanisms underlying the observed
      strength deficits are of muscular as well as neural origin . At the whole muscle level, a
      number of studies have examined skeletal muscle characteristics of MS patients, with some
      studies but not all, reporting loss of muscle mass and decreased or comparable maximal muscle
      strength.

      However, there is no study describing the features of lower extremity muscle architecture in
      multiple sclerosis. Muscle architecture is defined as the alignment of muscle fibers with
      respect to the axis of force. Although the diameters of the muscles of different sizes are
      quite similar to the diameters of the fibers, the sequences of these fibers contain several
      differences. The alignment of the muscle forming fibers has a significant effect on the force
      of muscle formation. The parameters that determine muscle architecture characteristics are
      the muscle fiber length, pennation angle, the physiological cross-sectional area. For each
      muscle these parameters may differ from each other. Any type of load in the case is the
      result of an adaptation process that results in muscle development. Muscle architecture
      allows the macroscopic understanding and interpretation of this adaptation process.

      Determining the muscle architecture of multiple sclerosis patients by ultrasound will guide
      the rehabilitation process.
observational model: Other
time perspective: Cross-Sectional
measure: Muscle Architecture Pennation Angle
time frame: The evaluation will be made on the first 1 day.
description: Pennation Angle will be assesed by ultrasound imaging.
measure: Muscle Architecture Muscle Fiber Lengh
time frame: The evaluation will be made on the first 1 day.
description: Muscle Fiber Lenght will be assesed by ultrasound imaging.
measure: Muscle Architecture Muscle Thickness
time frame: The evaluation will be made on the first 1 day.
description: Muscle Thickness will be assesed by ultrasound imaging.
measure: Muscle Strength
time frame: The evaluation will be made on the first 1 day.
description: Ouadriceps, Hamstring, Gastrosoleus and Gastrocnemius muscle Strenght will be asses with digital hand-held dynamometer (Commander PowerTrack II muscle tester).
measure: Circumference Measurement of Thigh
time frame: The evaluation will be made on the first 1 day.
description: Thigh circumference will be measured with a tape measure. Thigh circumference measurement will be measured from the midline of the inguinal line and superior patella.
measure: Circumference Measurement of shin
time frame: The evaluation will be made on the first 1 day.
description: Shin circumference will be measured with a tape measure.Shin circumference measurement will be measured from the poplital line and the middle point of the achilles.
measure: Thickness of subcutaneous fat from anterior thigh
time frame: The evaluation will be made on the first 1 day.
description: Subcutaneous fat will be assesed with skinfold from anterior thigh. At the same time the thickness of subcutaneous fat will also be evaluated by ultrasound imaging.
measure: Thickness of subcutaneous fat from posterior leg
time frame: The evaluation will be made on the first 1 day.
description: Subcutaneous fat will be assesed with skinfold from posterior leg. At the same time the thickness of subcutaneous fat will also be evaluated by ultrasound imaging.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Zekiye İpek Katırcı Kırmacı
role: Principal Investigator
affiliation: Sanko University
facility: 
country: Turkey
url: https://www.ncbi.nlm.nih.gov/pubmed/25264868
description: Multiple Sclerosis and Skeletal Muscle
citation: Wens I, Dalgas U, Vandenabeele F, Krekels M, Grevendonk L, Eijnde BO. Multiple sclerosis affects skeletal muscle characteristics. PLoS One. 2014 Sep 29;9(9):e108158. doi: 10.1371/journal.pone.0108158. eCollection 2014.
PMID: 25264868
responsible party type: Principal Investigator
investigator affiliation: Sanko University
investigator full name: zekiye ipek katırcı kırmacı
investigator title: Principal Investigator
mesh term: Multiple Sclerosis
mesh term: Sclerosis
sharing ipd: Undecided
ipd description: Sharing of data information has not yet been decided.