xml: <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/NCT05981313</url>
    </required_header>
    <id_info>
      <org_study_id>2023/52</org_study_id>
      <nct_id>NCT05981313</nct_id>
    </id_info>
    <brief_title>Viscoelastic Properties of Lower Extremity Muscles in Patients With Hemophilia</brief_title>
    <official_title>Evaluation of Viscoelastic Properties of Lower Extremity Muscles in Patients With Hemophilia</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hasan Kalyoncu University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Hasan Kalyoncu 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 our study is to evaluate the viscoelastic properties of lower extremity muscles in&#xD;
        patients with hemophilia A and hemophilia B secondarily to compare them with their healthy&#xD;
        peers.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Hemophilia is a rare inherited coagulation disorder that develops as a result of factor VIII&#xD;
        (hemophilia A) or factor IX (hemophilia B) deficiency, and is a chronic group of diseases&#xD;
        that mainly manifests with intra-articular (hemarthrosis) and intramuscular (hematoma)&#xD;
        bleeding, affecting quality of life. The presence of easy ecchymosis formation in early&#xD;
        childhood, especially intra-articular and intramuscular spontaneous bleeding, interventions&#xD;
        and a history of bleeding that lasted longer than expected after trauma should suggest&#xD;
        hemophilia. The severity of bleeding findings is directly related to the degree of deficiency&#xD;
        of hemophilia A and B. Hemarthroses due to bleeding in the joint (80%) and hematomas due to&#xD;
        intramuscular bleeding (20%) cause joint degeneration and muscle atrophy. The joint in which&#xD;
        hemarthrosis is most common is the knee joint, however, bleeding into the lower extremity&#xD;
        muscles seriously affects the activities of daily living and lower extremity functionality.&#xD;
        For this reason, the researchers aimed to evaluate the viscoelastic properties of lower&#xD;
        extremity muscles in hemophilia patients and, secondarily, to compare them with their healthy&#xD;
        peers.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 15, 2023</start_date>
    <completion_date type="Anticipated">December 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">August 16, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Lower extremity moscle tone (Hz)</measure>
      <time_frame>through of the study, average 6 months</time_frame>
      <description>The tone (Hz) of lower extremity muscles (Vastus Medialis Obliquus, Rectus Femoris, Vastus Lateralis, Biceps Femoris, Tibialis Anterior, Gastrocnemius) will be evaluated with MyotonPro device (Myoton Ltd). Vastus Medialis Obliquus, Rectus Femoris, Vastus Lateralis and Tibialis Anterior muscle measurements will be made from the reference points determined in the supine relaxed position, while Biceps Femoris and Gastrocnemius measurements will be made in the prone position with the ankle in the neutral position. Participants will be allowed to rest on the table for 10 minutes before the measurements are taken. The viscoelastic measurement will be repeated three times by determining the reference points (cm) of the relevant muscles and the averages will be recorded. Only measurements with a coefficient of variation less than 3% will be taken into account, otherwise the measurements will be repeated.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Lower extremity stiffness (N/m)</measure>
      <time_frame>through of the study, average 6 months</time_frame>
      <description>The stiffness (N/m) of lower extremity muscles (Vastus Medialis Obliquus, Rectus Femoris, Vastus Lateralis, Biceps Femoris, Tibialis Anterior, Gastrocnemius) will be evaluated with MyotonPro device (Myoton Ltd). Vastus Medialis Obliquus, Rectus Femoris, Vastus Lateralis and Tibialis Anterior muscle measurements will be made from the reference points determined in the supine relaxed position, while Biceps Femoris and Gastrocnemius measurements will be made in the prone position with the ankle in the neutral position. Participants will be allowed to rest on the table for 10 minutes before the measurements are taken. The viscoelastic measurement will be repeated three times by determining the reference points (cm) of the respective muscles and the averages will be recorded. Only measurements with a coefficient of variation less than 3% will be taken into account, otherwise the measurements will be repeated.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Lower extremity elasticity (log)</measure>
      <time_frame>through of the study, average 6 months</time_frame>
      <description>The elasticity (log) of lower extremity muscles (Vastus Medialis Obliquus, Rectus Femoris, Vastus Lateralis, Biceps Femoris, Tibialis Anterior, Gastrocnemius) will be evaluated with MyotonPro device (Myoton Ltd). Vastus Medialis Obliquus, Rectus Femoris, Vastus Lateralis and Tibialis Anterior muscle measurements will be made from the reference points determined in the supine relaxed position, while Biceps Femoris and Gastrocnemius measurements will be made in the prone position with the ankle in the neutral position. Participants will be allowed to rest on the table for 10 minutes before the measurements are taken. The viscoelastic measurement will be repeated three times by determining the reference points (cm) of the respective muscles and the averages will be recorded. Only measurements with a coefficient of variation less than 3% will be taken into account, otherwise the measurements will be repeated.</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Hemophilia</condition>
    <condition>Hemophilia A</condition>
    <condition>Hemophilia B</condition>
    <arm_group>
      <arm_group_label>Hemophilia Group</arm_group_label>
      <description>The viscoelastic properties (tone, stiffness, elasticity) of the lower extremity muscles (Vastus Medialis Obliquus, Rectus Femoris, Vastus Lateralis, Biceps Femoris, Tibialis Anterior, Gastrocnemius) of hemophilia patients who meet the study criteria will be evaluated with the MyotonPro device (Myoton Ltd).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <description>The viscoelastic properties (tone, stiffness, elasticity) of the lower extremity muscles (Vastus Medialis Obliquus, Rectus Femoris, Vastus Lateralis, Biceps Femoris, Tibialis Anterior, Gastrocnemius) of healthy children meeting the study criteria will be evaluated with the MyotonPro device (Myoton Ltd).</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Pediatric group hemophilia A and hemophilia B children living in Gaziantep constitute the&#xD;
          study population.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Children aged 4-17 years&#xD;
  &#xD;
            -  Those who have been diagnosed with Hemophilia A and Hemophilia B by a physician&#xD;
  &#xD;
            -  No history of acute bleeding&#xD;
  &#xD;
            -  Children who have family consent and volunteer to participate in the study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Those with a history of lower extremity surgery&#xD;
  &#xD;
            -  Those with neurological disease&#xD;
  &#xD;
            -  Those with a history of lower extremity hemarthrosis or hematoma in the last 1 month&#xD;
  &#xD;
            -  Patients with inhibitor positive&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Hemophilia A and B disease is an X-linked recessive disease. Therefore, girls become carriers and do not show muscle joint problems.</gender_description>
      <minimum_age>4 Years</minimum_age>
      <maximum_age>17 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Tuğba GÖNEN, Asst. Prof.</last_name>
      <phone>05050905846</phone>
      <email>tugba.badat@hku.edu.tr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Hasan Kalyoncu University</name>
        <address>
          <city>Gaziantep</city>
          <state>Şahinbey</state>
          <zip>27100</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <reference>
      <citation>Srivastava A, Santagostino E, Dougall A, Kitchen S, Sutherland M, Pipe SW, Carcao M, Mahlangu J, Ragni MV, Windyga J, Llinas A, Goddard NJ, Mohan R, Poonnoose PM, Feldman BM, Lewis SZ, van den Berg HM, Pierce GF; WFH Guidelines for the Management of Hemophilia panelists and co-authors. WFH Guidelines for the Management of Hemophilia, 3rd edition. Haemophilia. 2020 Aug;26 Suppl 6:1-158. doi: 10.1111/hae.14046. Epub 2020 Aug 3. No abstract available. Erratum In: Haemophilia. 2021 Jul;27(4):699.</citation>
      <PMID>32744769</PMID>
    </reference>
    <reference>
      <citation>Schafer GS, Valderramas S, Gomes AR, Budib MB, Wolff AL, Ramos AA. Physical exercise, pain and musculoskeletal function in patients with haemophilia: a systematic review. Haemophilia. 2016 May;22(3):e119-29. doi: 10.1111/hae.12909. Epub 2016 Apr 14.</citation>
      <PMID>27075748</PMID>
    </reference>
    <reference>
      <citation>De la Corte-Rodriguez H, Rodriguez-Merchan EC. The role of physical medicine and rehabilitation in haemophiliac patients. Blood Coagul Fibrinolysis. 2013 Jan;24(1):1-9. doi: 10.1097/MBC.0b013e32835a72f3.</citation>
      <PMID>23103725</PMID>
    </reference>
    <reference>
      <citation>Usgu S, Ramazanoglu E, Yakut Y. The Relation of Body Mass Index to Muscular Viscoelastic Properties in Normal and Overweight Individuals. Medicina (Kaunas). 2021 Sep 26;57(10):1022. doi: 10.3390/medicina57101022.</citation>
      <PMID>34684059</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 16, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Hasan Kalyoncu University</investigator_affiliation>
      <investigator_full_name>Tuğba GÖNEN</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <keyword>Hemophilia</keyword>
    <keyword>Muscle tone</keyword>
    <keyword>Stiffness</keyword>
    <keyword>Elasticity</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hemophilia A</mesh_term>
      <mesh_term>Hemophilia B</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05981313
  org study id: 2023/52
  nct id: NCT05981313
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of our study is to evaluate the viscoelastic properties of lower extremity muscles in
        patients with hemophilia A and hemophilia B secondarily to compare them with their healthy
        peers.
  Hemophilia is a rare inherited coagulation disorder that develops as a result of factor VIII
        (hemophilia A) or factor IX (hemophilia B) deficiency, and is a chronic group of diseases
        that mainly manifests with intra-articular (hemarthrosis) and intramuscular (hematoma)
        bleeding, affecting quality of life. The presence of easy ecchymosis formation in early
        childhood, especially intra-articular and intramuscular spontaneous bleeding, interventions
        and a history of bleeding that lasted longer than expected after trauma should suggest
        hemophilia. The severity of bleeding findings is directly related to the degree of deficiency
        of hemophilia A and B. Hemarthroses due to bleeding in the joint (80%) and hematomas due to
        intramuscular bleeding (20%) cause joint degeneration and muscle atrophy. The joint in which
        hemarthrosis is most common is the knee joint, however, bleeding into the lower extremity
        muscles seriously affects the activities of daily living and lower extremity functionality.
        For this reason, the researchers aimed to evaluate the viscoelastic properties of lower
        extremity muscles in hemophilia patients and, secondarily, to compare them with their healthy
        peers.
  observational model: Case-Control
  time perspective: Prospective
  measure: Lower extremity moscle tone (Hz)
  time frame: through of the study, average 6 months
  description: The tone (Hz) of lower extremity muscles (Vastus Medialis Obliquus, Rectus Femoris, Vastus Lateralis, Biceps Femoris, Tibialis Anterior, Gastrocnemius) will be evaluated with MyotonPro device (Myoton Ltd). Vastus Medialis Obliquus, Rectus Femoris, Vastus Lateralis and Tibialis Anterior muscle measurements will be made from the reference points determined in the supine relaxed position, while Biceps Femoris and Gastrocnemius measurements will be made in the prone position with the ankle in the neutral position. Participants will be allowed to rest on the table for 10 minutes before the measurements are taken. The viscoelastic measurement will be repeated three times by determining the reference points (cm) of the relevant muscles and the averages will be recorded. Only measurements with a coefficient of variation less than 3% will be taken into account, otherwise the measurements will be repeated.
  measure: Lower extremity stiffness (N/m)
  time frame: through of the study, average 6 months
  description: The stiffness (N/m) of lower extremity muscles (Vastus Medialis Obliquus, Rectus Femoris, Vastus Lateralis, Biceps Femoris, Tibialis Anterior, Gastrocnemius) will be evaluated with MyotonPro device (Myoton Ltd). Vastus Medialis Obliquus, Rectus Femoris, Vastus Lateralis and Tibialis Anterior muscle measurements will be made from the reference points determined in the supine relaxed position, while Biceps Femoris and Gastrocnemius measurements will be made in the prone position with the ankle in the neutral position. Participants will be allowed to rest on the table for 10 minutes before the measurements are taken. The viscoelastic measurement will be repeated three times by determining the reference points (cm) of the respective muscles and the averages will be recorded. Only measurements with a coefficient of variation less than 3% will be taken into account, otherwise the measurements will be repeated.
  measure: Lower extremity elasticity (log)
  time frame: through of the study, average 6 months
  description: The elasticity (log) of lower extremity muscles (Vastus Medialis Obliquus, Rectus Femoris, Vastus Lateralis, Biceps Femoris, Tibialis Anterior, Gastrocnemius) will be evaluated with MyotonPro device (Myoton Ltd). Vastus Medialis Obliquus, Rectus Femoris, Vastus Lateralis and Tibialis Anterior muscle measurements will be made from the reference points determined in the supine relaxed position, while Biceps Femoris and Gastrocnemius measurements will be made in the prone position with the ankle in the neutral position. Participants will be allowed to rest on the table for 10 minutes before the measurements are taken. The viscoelastic measurement will be repeated three times by determining the reference points (cm) of the respective muscles and the averages will be recorded. Only measurements with a coefficient of variation less than 3% will be taken into account, otherwise the measurements will be repeated.
  arm group label: Hemophilia Group
  description: The viscoelastic properties (tone, stiffness, elasticity) of the lower extremity muscles (Vastus Medialis Obliquus, Rectus Femoris, Vastus Lateralis, Biceps Femoris, Tibialis Anterior, Gastrocnemius) of hemophilia patients who meet the study criteria will be evaluated with the MyotonPro device (Myoton Ltd).
  arm group label: Control Group
  description: The viscoelastic properties (tone, stiffness, elasticity) of the lower extremity muscles (Vastus Medialis Obliquus, Rectus Femoris, Vastus Lateralis, Biceps Femoris, Tibialis Anterior, Gastrocnemius) of healthy children meeting the study criteria will be evaluated with the MyotonPro device (Myoton Ltd).
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Male
  gender based: Yes
  gender description: Hemophilia A and B disease is an X-linked recessive disease. Therefore, girls become carriers and do not show muscle joint problems.
  minimum age: 4 Years
  maximum age: 17 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Tuğba GÖNEN, Asst. Prof.
  phone: 05050905846
  email: tugba.badat@hku.edu.tr
  facility: 
  country: Turkey
  citation: Srivastava A, Santagostino E, Dougall A, Kitchen S, Sutherland M, Pipe SW, Carcao M, Mahlangu J, Ragni MV, Windyga J, Llinas A, Goddard NJ, Mohan R, Poonnoose PM, Feldman BM, Lewis SZ, van den Berg HM, Pierce GF; WFH Guidelines for the Management of Hemophilia panelists and co-authors. WFH Guidelines for the Management of Hemophilia, 3rd edition. Haemophilia. 2020 Aug;26 Suppl 6:1-158. doi: 10.1111/hae.14046. Epub 2020 Aug 3. No abstract available. Erratum In: Haemophilia. 2021 Jul;27(4):699.
  PMID: 32744769
  citation: Schafer GS, Valderramas S, Gomes AR, Budib MB, Wolff AL, Ramos AA. Physical exercise, pain and musculoskeletal function in patients with haemophilia: a systematic review. Haemophilia. 2016 May;22(3):e119-29. doi: 10.1111/hae.12909. Epub 2016 Apr 14.
  PMID: 27075748
  citation: De la Corte-Rodriguez H, Rodriguez-Merchan EC. The role of physical medicine and rehabilitation in haemophiliac patients. Blood Coagul Fibrinolysis. 2013 Jan;24(1):1-9. doi: 10.1097/MBC.0b013e32835a72f3.
  PMID: 23103725
  citation: Usgu S, Ramazanoglu E, Yakut Y. The Relation of Body Mass Index to Muscular Viscoelastic Properties in Normal and Overweight Individuals. Medicina (Kaunas). 2021 Sep 26;57(10):1022. doi: 10.3390/medicina57101022.
  PMID: 34684059
  responsible party type: Principal Investigator
  investigator affiliation: Hasan Kalyoncu University
  investigator full name: Tuğba GÖNEN
  investigator title: Assistant Professor
  mesh term: Hemophilia A
  mesh term: Hemophilia B
  sharing ipd: No