<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT2016013126279N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-04-26</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences (TUMS)</primary_sponsor>
      <public_title>Effects of rehabilitation treatment on vestibulo-ocular reflex</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the vestibulo-ocular reflex in patients with posterior semicircular canal benign paroxysmal positional vertigo before and after rehabilitation treatment assessed by video head impulse test</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/21817</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Benign paroxysmal positional vertigo.</hc_freetext>
      <i_freetext>With the patient sitting upright, the head is turned 45 degrees to the patient’s affected side. The patient is then moved from the sitting position to the supine position with the head hanging below the top end of the examination&#13;
table at an angle of 20 degrees. The head is turned 90 degrees toward the unaffected&#13;
left side.The head is then turned another 90 degrees, to a face-down position,and the trunk is turned 90 degrees in the same direction,&#13;
so that the patient is lying on the unaffected&#13;
side. The patient is then moved to the sitting position. Each position should be maintained until the induced nystagmus and vertigo resolve, but always for a minimum of 30 seconds. The rahabilitation procedure is performed in maximum two sessions (with one week interval)..</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mansoureh Adel Ghahraman</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Audiology, School of Rehabilitation, Tehran University of Medical Sciences (TUMS)</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>002177535132</telephone>
        <email>madel@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences (TUMS)</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mansoureh Adel Ghahraman</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Audiology, School of Rehabilitation, Tehran University of Medical Sciences (TUMS)</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>002177535132</telephone>
        <email>madel@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: posterior semicircular canal benign paroxysmal positional vertigo; no other vestibular disorders; no cervical problem; no peripheral disorder in the right eye.&#13;
Exclusion criteria: reluctant to cooperation during treatment sessions; no vertigo release after second rehabilitation session; occurrence of other vestibular disorders during study; feeling pain in cervical area during vHIT; nausea or vomiting during vHIT.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>H81.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Benign paroxysmal vertigo</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>With the patient sitting upright, the head is turned 45 degrees to the patient’s affected side. The patient is then moved from the sitting position to the supine position with the head hanging below the top end of the examination&#13;
table at an angle of 20 degrees. The head is turned 90 degrees toward the unaffected&#13;
left side.The head is then turned another 90 degrees, to a face-down position,and the trunk is turned 90 degrees in the same direction,&#13;
so that the patient is lying on the unaffected&#13;
side. The patient is then moved to the sitting position. Each position should be maintained until the induced nystagmus and vertigo resolve, but always for a minimum of 30 seconds. The rahabilitation procedure is performed in maximum two sessions (with one week interval).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Mean vetibulo-ocular reflex gain in each semicircular canal. Timepoint: before and after treatment. Method of measurement: ICS impulse (GN Otometrics, USA).</prim_outcome>
      <prim_outcome>Covert saccades. Timepoint: before and after treatment. Method of measurement: ICS impulse (GN Otometrics, USA).</prim_outcome>
      <prim_outcome>Overt saccades. Timepoint: before and after treatment. Method of measurement: ICS impulse (GN Otometrics, USA).</prim_outcome>
      <prim_outcome>Gain symmetry. Timepoint: before and after treatment. Method of measurement: calculation.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Tehran University of Medical Sciences (TUMS)</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-11-22</approval_date>
        <contact_name>Tehran University of Medical Sciences (TUMS)</contact_name>
        <contact_address>Enqelab Ave. Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
