<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/NCT04406519</url>
  </required_header>
  <id_info>
    <org_study_id>Necmettin Erb. Physiotherapy-3</org_study_id>
    <nct_id>NCT04406519</nct_id>
  </id_info>
  <brief_title>Evaluation of Static Postural Balance in Children With Hemophilia and Its Relationship With Joint Health</brief_title>
  <official_title>Static Postural Balance Evaluation in Children With Severe Haemophilia and Investigation of Its Relationship With Joint Health: a Cross-sectional Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Necmettin Erbakan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Necmettin Erbakan 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>
      Hemophilia is a rare hematological disorder characterized by a partial or complete deficiency&#xD;
      of clotting factor VIII or IX.Bleeding disorders mainly affect the musculoskeletal system.&#xD;
      Intra-articular bleeding is an important complication related to hemophilia and usually&#xD;
      occurs in large synovial joints such as knees and ankles. Initially, these bleeds occur&#xD;
      non-specific spontaneously and usually affect one joint, and repeated bleeding makes that&#xD;
      joint a target joint. Postural balance can be defined as the ability to maintain a stable&#xD;
      posture for maximum duration with minimal body sway, or to hold the body centre of gravity&#xD;
      (CoG) over its base support in varying conditions (1). Somatosensorial information from&#xD;
      mechanoreceptors, visual and vestibular receptors is required to maintain postural balance.&#xD;
      Postural balance is tried to be controlled by the postural adjustments provided by the&#xD;
      contraction of the lower limb muscles and trunk muscles before perturbation. Spontaneous&#xD;
      hemarthrosis is a distinctive feature of severe haemophilia, and that recurrent bleedings may&#xD;
      likely to cause postural balance disorders by disrupting proprioceptive inputs from&#xD;
      mechanoreceptors in the joint. Data on how bleeding affects postural balance in children with&#xD;
      hemophilia is unclear.In the relationship between the clinical evaluation of hemophilia and&#xD;
      postural balance, there is little research in the literature.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study was to investigate the changes in static postural balance parameters&#xD;
      more reliably and comprehensively with a longer test duration and to reveal the relationship&#xD;
      between balance parameters and joint health score in children with hemophilia. The&#xD;
      investigator's hypothesis was that in children with hemophilia (CwH), postural balance was&#xD;
      correlated with joint health status and had poor static postural balance compared to healthy&#xD;
      peers.&#xD;
&#xD;
      Twenty-one CwH aged 6 to 18 years who developed hemophilic arthropathy in at least one of the&#xD;
      lower limb joints due to severe hemophilia and twenty-one healthy peers were included in the&#xD;
      study.&#xD;
&#xD;
      The Hemophilia Joint Health Score (HJHS), a valid and reliable test, was used to measure the&#xD;
      joint health in CwH. Muscle strengths were measured with digital dynamometer. The kinetic&#xD;
      devices most commonly used to evaluate in the laboratory evaluation of postural balance are&#xD;
      the force platform and are considered the gold standard method. In the postural balance&#xD;
      evaluation, changes in the X and Y axis were used. The amplitude of these changes, the&#xD;
      standard deviation of the displacement, and the velocity were evaluated. In addition, the&#xD;
      ellipse area and perimeter were measured.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2018</start_date>
  <completion_date type="Actual">May 15, 2019</completion_date>
  <primary_completion_date type="Actual">July 1, 2018</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>Hemophilia Joint Health Score</measure>
    <time_frame>1 month</time_frame>
    <description>The score for each index-joint range from 0 to 20 and the lower limb joint score from 0 to 80. A high score indicates that the joint health is worse.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Center of Pressure (CoP)- CoPX and CoPY</measure>
    <time_frame>1 month</time_frame>
    <description>Amplitude of CoP is the difference between the biggest and smallest CoP displacement for X-axis (CoPX) and Y-axis (CoPY), the smaller the score, the better the postural stability.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Velocity- Mediolateral (MLV) and Anteroposterior (APV)</measure>
    <time_frame>1 month</time_frame>
    <description>The velocity is calculated by dividing the CoP excursion by trial time and expressed in mm/sec. It reflects the effectiveness of the postural stability- the bigger the velocity indicates the worse the postural control.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Standard deviation of body sway- Mediolateral (MLSD) and Anteroposterior (APSD)</measure>
    <time_frame>1 month</time_frame>
    <description>The lower standard deviation in the body sway indicates that the postural balance is well.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ellipse Area</measure>
    <time_frame>1 month</time_frame>
    <description>%90 of the total area scanned in the mediolateral and anteroposterior direction is calculated using an ellipse. A high score indicates that postural balance is worse</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Perimeter</measure>
    <time_frame>1 month</time_frame>
    <description>Quantifies the size of the displacement based upon the total distance scanned in mm, and the higher the length of the scanned area considered that postural stability is poor</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Muscle strength</measure>
    <time_frame>1 month</time_frame>
    <description>The flexors and extensors of the knee were measured by giving the resistance from proximal malleoli when the hip and knee were in 90° flexion during sitting position. The dorsi and plantar flexors of ankle were measured in the lower limb stabilized in supine position, giving resistance from the proximal of the metatarsophalangeal joint and was recorded in pounds.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Standard deviation of the trunk</measure>
    <time_frame>1 month</time_frame>
    <description>Total,anteroposterior and mediolateral standard deviation of the trunk were measured in degrees by the sensors. The lower standard deviation in the trunk sway indicates that the postural balance is well.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">42</enrollment>
  <condition>Hemophilia</condition>
  <condition>Arthropathy of Knee</condition>
  <condition>Arthropathy of Ankle or Foot</condition>
  <arm_group>
    <arm_group_label>Hemophilia Group</arm_group_label>
    <description>The inclusion criteria in the hemophilia group were as follows; patients aged 6 to 18 years who developed HA in at least one of the lower limb joints due to severe haemophilia (total lower limb HJHS ≥3); to be receiving prophylaxis but have no major bleeding that could affect the musculoskeletal system in the past two weeks; and who did not perform regular physical activity and sports.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <description>The control group was consisted of healthy peers. The exclusion criteria in the control group were as follows: who had any auditory and visual impairment; who underwent orthopedic injuries including lower limb; and who had any neurological or cognitive impairment that could affect balance.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Hemophilic children in Van province&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 6 to 18 years&#xD;
&#xD;
          -  Participants do not perform regular physical activity and sports.&#xD;
&#xD;
          -  For hemophilia group who developed hemophilic arthropathy in at least one of the lower&#xD;
             limb joints due to severe hemophilia (total lower limb hemophilia joint health score&#xD;
             ≥3).&#xD;
&#xD;
          -  For hemophilia group patients to be receiving prophylaxis but have no major bleeding&#xD;
             that could affect the musculoskeletal system in the past two weeks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have any auditory and visual impairment&#xD;
&#xD;
          -  Undergo any orthopedic injuries including lower limb&#xD;
&#xD;
          -  Have any neurological or cognitive disorders&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ahmet Fayik Oner, Prof.</last_name>
    <role>Study Chair</role>
    <affiliation>Van Yuzuncu Yil University Faculty of Medicine Dept of Pediatric Hematology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kamuran Karaman, Assoc. Prof.</last_name>
    <role>Study Director</role>
    <affiliation>Van Yuzuncu Yil University Faculty of Medicine Dept of Pediatric Hematology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Seyhmus Kaplan, Assoc. Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Van Yuzuncu Yil University Faculty of Medicine Dept of Sports Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yuzuncu Yil University</name>
      <address>
        <city>Van</city>
        <state>Bardakcı</state>
        <zip>65090</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 20, 2020</study_first_submitted>
  <study_first_submitted_qc>May 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>May 23, 2020</last_update_submitted>
  <last_update_submitted_qc>May 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Necmettin Erbakan University</investigator_affiliation>
    <investigator_full_name>Necati Muhammed TAT</investigator_full_name>
    <investigator_title>Lecturer</investigator_title>
  </responsible_party>
  <keyword>haemophilia</keyword>
  <keyword>balance</keyword>
  <keyword>joint health</keyword>
  <keyword>arthropathy</keyword>
  <keyword>children</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Joint Diseases</mesh_term>
    <mesh_term>Hemophilia A</mesh_term>
  </condition_browse>
  <!-- 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/NCT04406519
org study id: Necmettin Erb. Physiotherapy-3
nct id: NCT04406519
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Hemophilia is a rare hematological disorder characterized by a partial or complete deficiency
      of clotting factor VIII or IX.Bleeding disorders mainly affect the musculoskeletal system.
      Intra-articular bleeding is an important complication related to hemophilia and usually
      occurs in large synovial joints such as knees and ankles. Initially, these bleeds occur
      non-specific spontaneously and usually affect one joint, and repeated bleeding makes that
      joint a target joint. Postural balance can be defined as the ability to maintain a stable
      posture for maximum duration with minimal body sway, or to hold the body centre of gravity
      (CoG) over its base support in varying conditions (1). Somatosensorial information from
      mechanoreceptors, visual and vestibular receptors is required to maintain postural balance.
      Postural balance is tried to be controlled by the postural adjustments provided by the
      contraction of the lower limb muscles and trunk muscles before perturbation. Spontaneous
      hemarthrosis is a distinctive feature of severe haemophilia, and that recurrent bleedings may
      likely to cause postural balance disorders by disrupting proprioceptive inputs from
      mechanoreceptors in the joint. Data on how bleeding affects postural balance in children with
      hemophilia is unclear.In the relationship between the clinical evaluation of hemophilia and
      postural balance, there is little research in the literature.
The aim of this study was to investigate the changes in static postural balance parameters
      more reliably and comprehensively with a longer test duration and to reveal the relationship
      between balance parameters and joint health score in children with hemophilia. The
      investigator's hypothesis was that in children with hemophilia (CwH), postural balance was
      correlated with joint health status and had poor static postural balance compared to healthy
      peers.

      Twenty-one CwH aged 6 to 18 years who developed hemophilic arthropathy in at least one of the
      lower limb joints due to severe hemophilia and twenty-one healthy peers were included in the
      study.

      The Hemophilia Joint Health Score (HJHS), a valid and reliable test, was used to measure the
      joint health in CwH. Muscle strengths were measured with digital dynamometer. The kinetic
      devices most commonly used to evaluate in the laboratory evaluation of postural balance are
      the force platform and are considered the gold standard method. In the postural balance
      evaluation, changes in the X and Y axis were used. The amplitude of these changes, the
      standard deviation of the displacement, and the velocity were evaluated. In addition, the
      ellipse area and perimeter were measured.
observational model: Case-Control
time perspective: Prospective
measure: Hemophilia Joint Health Score
time frame: 1 month
description: The score for each index-joint range from 0 to 20 and the lower limb joint score from 0 to 80. A high score indicates that the joint health is worse.
measure: Center of Pressure (CoP)- CoPX and CoPY
time frame: 1 month
description: Amplitude of CoP is the difference between the biggest and smallest CoP displacement for X-axis (CoPX) and Y-axis (CoPY), the smaller the score, the better the postural stability.
measure: Velocity- Mediolateral (MLV) and Anteroposterior (APV)
time frame: 1 month
description: The velocity is calculated by dividing the CoP excursion by trial time and expressed in mm/sec. It reflects the effectiveness of the postural stability- the bigger the velocity indicates the worse the postural control.
measure: Standard deviation of body sway- Mediolateral (MLSD) and Anteroposterior (APSD)
time frame: 1 month
description: The lower standard deviation in the body sway indicates that the postural balance is well.
measure: Ellipse Area
time frame: 1 month
description: %90 of the total area scanned in the mediolateral and anteroposterior direction is calculated using an ellipse. A high score indicates that postural balance is worse
measure: Perimeter
time frame: 1 month
description: Quantifies the size of the displacement based upon the total distance scanned in mm, and the higher the length of the scanned area considered that postural stability is poor
measure: Muscle strength
time frame: 1 month
description: The flexors and extensors of the knee were measured by giving the resistance from proximal malleoli when the hip and knee were in 90° flexion during sitting position. The dorsi and plantar flexors of ankle were measured in the lower limb stabilized in supine position, giving resistance from the proximal of the metatarsophalangeal joint and was recorded in pounds.
measure: Standard deviation of the trunk
time frame: 1 month
description: Total,anteroposterior and mediolateral standard deviation of the trunk were measured in degrees by the sensors. The lower standard deviation in the trunk sway indicates that the postural balance is well.
arm group label: Hemophilia Group
description: The inclusion criteria in the hemophilia group were as follows; patients aged 6 to 18 years who developed HA in at least one of the lower limb joints due to severe haemophilia (total lower limb HJHS ≥3); to be receiving prophylaxis but have no major bleeding that could affect the musculoskeletal system in the past two weeks; and who did not perform regular physical activity and sports.
arm group label: Control Group
description: The control group was consisted of healthy peers. The exclusion criteria in the control group were as follows: who had any auditory and visual impairment; who underwent orthopedic injuries including lower limb; and who had any neurological or cognitive impairment that could affect balance.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 6 Years
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ahmet Fayik Oner, Prof.
role: Study Chair
affiliation: Van Yuzuncu Yil University Faculty of Medicine Dept of Pediatric Hematology
last name: Kamuran Karaman, Assoc. Prof.
role: Study Director
affiliation: Van Yuzuncu Yil University Faculty of Medicine Dept of Pediatric Hematology
last name: Seyhmus Kaplan, Assoc. Prof.
role: Principal Investigator
affiliation: Van Yuzuncu Yil University Faculty of Medicine Dept of Sports Medicine
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Necmettin Erbakan University
investigator full name: Necati Muhammed TAT
investigator title: Lecturer
mesh term: Joint Diseases
mesh term: Hemophilia A