<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/NCT02199639</url>
  </required_header>
  <id_info>
    <org_study_id>ibHEro</org_study_id>
    <secondary_id>ibHEro</secondary_id>
    <nct_id>NCT02199639</nct_id>
  </id_info>
  <brief_title>Transcultural Multidisciplinary Evaluation of Patients With Hemophili</brief_title>
  <acronym>ibHEro</acronym>
  <official_title>Multidisciplinary Evaluation of Patients With Hemophilia of Spain, El Salvador and Bolivia. An Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad Católica San Antonio de Murcia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad Católica San Antonio de Murcia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Multidisciplinary evaluation of patients with hemophilia Spain, El Salvador and Bolivia. It&#xD;
      aims to analyze and evaluate the skeletal muscle of patients affected with hemophilia Spain,&#xD;
      El Salvador and Bolivia; describe deficit mobility and muscular strength, depending on the&#xD;
      degree of injury, age, presence of inhibitors and the development of physical activity;&#xD;
      identify the relationship between the functional deficit by clinical assessment performed&#xD;
      with the use of validated measurement scales, the assessment of the degree of injury to&#xD;
      specific scales of hemophilia; detect biomechanical alterations of the lower limbs and their&#xD;
      impact on gait in patients with hemophilia; and evaluate the factors that influence the&#xD;
      perception of illness and quality of life of patients with hemophilia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Descriptive study of joint involvement in patients with hemophilia Spain, El Salvador and&#xD;
      Bolivia.&#xD;
&#xD;
      Descriptive study of abnormal joint mobility and muscle strength as a result of acute&#xD;
      conditions or the development of chronic articular sequelae.&#xD;
&#xD;
      Descriptive study of biomechanical changes in lower limb joints and their impact on gait in&#xD;
      patients with hemophilia.&#xD;
&#xD;
      Descriptive study of the overall articular involvement (crepitus, pain, biomechanical and&#xD;
      functional changes) in patients with hemophilia.&#xD;
&#xD;
      Descriptive study of the relationship between skeletal muscle pathology in patients with&#xD;
      hemophilia and their perception of it, and their quality of life.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>March 2014</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Anticipated">August 2015</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>Assessment of range of motion of elbow, knee and ankle</measure>
    <time_frame>Screening visit</time_frame>
    <description>We will use a goniometric evaluation, along the lines indicated by Querol for assessing the range of motion in patients with hemophilia</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of muscle strength of arm, thigh and leg</measure>
    <time_frame>Screening visit</time_frame>
    <description>We will use a measure of muscular balance with the guidelines outlined by Daniels, with the adaptation of Querol for assessing muscle strength in patients with hemophilia</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of perception of joint pain</measure>
    <time_frame>Screening visit</time_frame>
    <description>We will use the visual analogue scale (VAS) for the assessment of joint pain in patients with hemophilia, with a scale from 0 (no pain) to 10 (maximum pain).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of the status joint</measure>
    <time_frame>Screening visit</time_frame>
    <description>We will use the specific questionnaire haemophilia: Haemophilia Joint Healts Score (HJHS) for the assessment of joint status</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluation of the performance of activities of daily living</measure>
    <time_frame>Screening visit</time_frame>
    <description>We will use the questionnaire Haemophilia Activities List (HAL), specific for patients with hemophilia</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of physical performance of patients with hemophilia</measure>
    <time_frame>Screening visit</time_frame>
    <description>We will use the Physical Functioning scale (HEP-Test-Q), specific for patients with hemophilia</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of personality traits of children</measure>
    <time_frame>Screening visit</time_frame>
    <description>We will use the questionnaire Eysenck Personality Questionnaire Junior (EPQJ)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluation of perceived quality of life for patients with hemophilia</measure>
    <time_frame>Screening visit</time_frame>
    <description>We will use the Hemophilia-QoL and the Child Health and Illness Profile (CHIP-CE) questionnaires for children; and the Hemophilia-QoL and A36 and 36 Health Survey (SF36) questionnairesfor adults .</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical variables of patients with hemophilia</measure>
    <time_frame>Screening visit</time_frame>
    <description>Age (years); weight (kg); Size (cm); type of haemophilia (A or B); severity of hemophilia (severe / moderate / mild); pharmacological treatment (prophylactic / on demand); presence of inhibitors; central venous catheter; family history of hemophilia; hemarthrosis in the last month; arthropathy diagnosed in some joint; use of orthoses</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Socio-demographic variables of patients with hemophilia</measure>
    <time_frame>Screening visit</time_frame>
    <description>Number of hospital visits per year (reason); Distance to hospital (km); Academic formation of the patient (university studies / vocational training / basic studies / no studies); academic formation of the parents (university studies / vocational training / basic studies / no studies); patient employment (self-employment / employment has as an employed person / unemployed / retirement); parents employment (self-employment / employment has as an employed person / unemployed / retirement);</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Patients With Haemophilia</condition>
  <arm_group>
    <arm_group_label>Spain</arm_group_label>
    <description>Group of patients with hemophilia recruited in the Region of Murcia (Spain) and evaluated in the Universidad Católica San Antonio between June and July 2014.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>El Salvador</arm_group_label>
    <description>Group of patients with hemophilia recruited in the city of San Salvador (El Salvador) and evaluated in the Hospital Nacional Rosales and the Hospital Nacional de niños &quot;Benjamín Bloom&quot; from San Salvador in April 2014.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bolivia</arm_group_label>
    <description>Group of patients with hemophilia recruited in the city of Santa Cruz (Bolivia) and evaluated at the Hospital Nacional de niños in Santa Cruz August 2014.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with haemophilia from Spain, El Salvador and Bolivia&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with hemophilia A and B.&#xD;
&#xD;
          -  Patients of all ages (pediatric, adolescents, youth and adults).&#xD;
&#xD;
          -  With or without joint involvement clinically diagnosed, and with or without a previous&#xD;
             history of hemarthrosis joint load legs.&#xD;
&#xD;
          -  Patients with or without inhibitors.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients without prior ambulation capacity.&#xD;
&#xD;
          -  Patients diagnosed with other congenital coagulopathy (von Willebrand disease, etc..).&#xD;
&#xD;
          -  Patients with neurological or cognitive impairments that prevent understanding the&#xD;
             questionnaires and physical tests.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>RUBEN CUESTA-BARRIUSO, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidad Católica San Antonio</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>RUBÉN CUESTA-BARRIUSO, PhD</last_name>
    <phone>968278806</phone>
    <email>ruben.cuestab@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Universidad Católica San Antonio de Murcia</name>
      <address>
        <city>Murcia</city>
        <zip>30107</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>RUBÉN CUESTA-BARRIUSO, PhD</last_name>
      <phone>968278806</phone>
      <email>ruben.cuestab@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>ANA TORRES-ORTUÑO, PhD</last_name>
      <phone>968278806</phone>
      <email>atorres.ortuno@gmail.com</email>
    </contact_backup>
    <investigator>
      <last_name>RUBÉN CUESTA-BARRIUSO, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>ANA TORRES-ORTUÑO, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>JOAQUÍN NIETO-MUNUERA, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>March 2014</verification_date>
  <study_first_submitted>July 23, 2014</study_first_submitted>
  <study_first_submitted_qc>July 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 24, 2014</study_first_posted>
  <last_update_submitted>April 29, 2015</last_update_submitted>
  <last_update_submitted_qc>April 29, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 30, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad Católica San Antonio de Murcia</investigator_affiliation>
    <investigator_full_name>RUBÉN CUESTA-BARRIUSO</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <keyword>Haemophilia</keyword>
  <keyword>Arthropathy</keyword>
  <keyword>Range of Movement</keyword>
  <keyword>Strength</keyword>
  <keyword>Proprioception</keyword>
  <keyword>Gait</keyword>
  <keyword>Quality of Life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT02199639
org study id: ibHEro
secondary id: ibHEro
nct id: NCT02199639
lead sponsor: 
has dmc: No
Multidisciplinary evaluation of patients with hemophilia Spain, El Salvador and Bolivia. It
      aims to analyze and evaluate the skeletal muscle of patients affected with hemophilia Spain,
      El Salvador and Bolivia; describe deficit mobility and muscular strength, depending on the
      degree of injury, age, presence of inhibitors and the development of physical activity;
      identify the relationship between the functional deficit by clinical assessment performed
      with the use of validated measurement scales, the assessment of the degree of injury to
      specific scales of hemophilia; detect biomechanical alterations of the lower limbs and their
      impact on gait in patients with hemophilia; and evaluate the factors that influence the
      perception of illness and quality of life of patients with hemophilia.
Descriptive study of joint involvement in patients with hemophilia Spain, El Salvador and
      Bolivia.

      Descriptive study of abnormal joint mobility and muscle strength as a result of acute
      conditions or the development of chronic articular sequelae.

      Descriptive study of biomechanical changes in lower limb joints and their impact on gait in
      patients with hemophilia.

      Descriptive study of the overall articular involvement (crepitus, pain, biomechanical and
      functional changes) in patients with hemophilia.

      Descriptive study of the relationship between skeletal muscle pathology in patients with
      hemophilia and their perception of it, and their quality of life.
observational model: Cohort
time perspective: Prospective
measure: Assessment of range of motion of elbow, knee and ankle
time frame: Screening visit
description: We will use a goniometric evaluation, along the lines indicated by Querol for assessing the range of motion in patients with hemophilia
measure: Assessment of muscle strength of arm, thigh and leg
time frame: Screening visit
description: We will use a measure of muscular balance with the guidelines outlined by Daniels, with the adaptation of Querol for assessing muscle strength in patients with hemophilia
measure: Assessment of perception of joint pain
time frame: Screening visit
description: We will use the visual analogue scale (VAS) for the assessment of joint pain in patients with hemophilia, with a scale from 0 (no pain) to 10 (maximum pain).
measure: Assessment of the status joint
time frame: Screening visit
description: We will use the specific questionnaire haemophilia: Haemophilia Joint Healts Score (HJHS) for the assessment of joint status
measure: Evaluation of the performance of activities of daily living
time frame: Screening visit
description: We will use the questionnaire Haemophilia Activities List (HAL), specific for patients with hemophilia
measure: Assessment of physical performance of patients with hemophilia
time frame: Screening visit
description: We will use the Physical Functioning scale (HEP-Test-Q), specific for patients with hemophilia
measure: Assessment of personality traits of children
time frame: Screening visit
description: We will use the questionnaire Eysenck Personality Questionnaire Junior (EPQJ)
measure: Evaluation of perceived quality of life for patients with hemophilia
time frame: Screening visit
description: We will use the Hemophilia-QoL and the Child Health and Illness Profile (CHIP-CE) questionnaires for children; and the Hemophilia-QoL and A36 and 36 Health Survey (SF36) questionnairesfor adults .
measure: Clinical variables of patients with hemophilia
time frame: Screening visit
description: Age (years); weight (kg); Size (cm); type of haemophilia (A or B); severity of hemophilia (severe / moderate / mild); pharmacological treatment (prophylactic / on demand); presence of inhibitors; central venous catheter; family history of hemophilia; hemarthrosis in the last month; arthropathy diagnosed in some joint; use of orthoses
measure: Socio-demographic variables of patients with hemophilia
time frame: Screening visit
description: Number of hospital visits per year (reason); Distance to hospital (km); Academic formation of the patient (university studies / vocational training / basic studies / no studies); academic formation of the parents (university studies / vocational training / basic studies / no studies); patient employment (self-employment / employment has as an employed person / unemployed / retirement); parents employment (self-employment / employment has as an employed person / unemployed / retirement);
arm group label: Spain
description: Group of patients with hemophilia recruited in the Region of Murcia (Spain) and evaluated in the Universidad Católica San Antonio between June and July 2014.
arm group label: El Salvador
description: Group of patients with hemophilia recruited in the city of San Salvador (El Salvador) and evaluated in the Hospital Nacional Rosales and the Hospital Nacional de niños "Benjamín Bloom" from San Salvador in April 2014.
arm group label: Bolivia
description: Group of patients with hemophilia recruited in the city of Santa Cruz (Bolivia) and evaluated at the Hospital Nacional de niños in Santa Cruz August 2014.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 6 Years
maximum age: 65 Years
healthy volunteers: No
last name: RUBEN CUESTA-BARRIUSO, PhD
role: Principal Investigator
affiliation: Universidad Católica San Antonio
last name: RUBÉN CUESTA-BARRIUSO, PhD
phone: 968278806
email: ruben.cuestab@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Universidad Católica San Antonio de Murcia
investigator full name: RUBÉN CUESTA-BARRIUSO
investigator title: PhD
mesh term: Hemophilia A