<?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>IRCT20211022052835N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-12-01</date_registration>
      <primary_sponsor>Shifa Tameer-e-Millat University</primary_sponsor>
      <public_title>Comparison of Semont and Epley's maneuver in vertigo</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of Semont and Epley's maneuver in Patients with benign paroxysmal positional vertigo</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-04-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>56</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/59543</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: N/A, Randomization description: In this study simple random sampling technique is used by sealed envelop method by using a computerized random number generator. The sequence of random allocation is done by an individual who has not directly involved in the study. Random numbers is written on index cards and placed in thick and opaque sealed envelops before the study. After taking consent from the patient for their participation in the study, the therapist opens the envelop and give the respective treatments to the patients . The study is single blinded as participants is not aware of the intervention group they are placed in, Blinding description: Participants are single blinded as they don't know which treatment plan or intervention is given to them.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Benign paroxysmal positional vertigo is a spinning sensation in head that leads to vertigo and dizziness. it can be treated with rehabilitative techniques and positioning maneuvers..</hc_freetext>
      <i_freetext>Intervention 1: Intervention group1 : Epley's Group  is given Epley's maneuver has sequential movement of the head into four positions  staying in each position for roughly 30 seconds. It includes supine lying, 45 degree head rotation, head extension , head rotation and then sitting. It is intended to move debris or "ear otoconia" out of the sensitive part of the ear (posterior canal) to a less sensitive location. It is also sometimes called the "canalith repositioning maneuver". Intervention 2: Intervention group 2: Semont Group  is given Semont maneuver in which patient sit on the edge of bed. First patient head is turned 45 degrees to the right and then quickly lie down him on left side. This position is maintained for 30 seconds. And then the patient is quickly move to lie down on the opposite end of the bed. After that return him slowly to sitting and wait a few minutes.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fouzia Batool</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pitras Bukhari Road, Shifa Tameer-e-Millat University, H-8/4, Islamabad</address>
        <city>Islamabad</city>
        <country1>Pakistan</country1>
        <zip>44000</zip>
        <telephone>+92 332 7120385</telephone>
        <email>fouzia_dpt.ahs@stmu.edu.pk</email>
        <affiliation>Shifa Tameer-e-Millat University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shiza Rizwan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>House no :44, St :05 ,british homes I-12 Islamabad</address>
        <city>Islamabad</city>
        <country1>Pakistan</country1>
        <zip>46060</zip>
        <telephone>+92 336 5498116</telephone>
        <email>shizarizwan2@gmail.com</email>
        <affiliation>Shifa tameer-e- millat university islamabad</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosed Benign paroxysmal positional vertigo
Patients with active daily life Activities  between ages 25 to 65 years
Patients having positional dizziness
Patients with recurrent rotatory vertigo attacks proceeded by rapid and/or gravity-dependent head movements</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients who have any neuromuscular comorbidity
Patients on any kind of drug or sedative during study
Patients with epilepsy or on epileptic drugs
Patient with highly impaired vision
Bilateral Benign paroxysmal positional vertigo</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>H81.10</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Benign paroxysmal positional vertigo, unspecified ear</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group1 : Epley's Group  is given Epley's maneuver has sequential movement of the head into four positions  staying in each position for roughly 30 seconds. It includes supine lying, 45 degree head rotation, head extension , head rotation and then sitting. It is intended to move debris or "ear otoconia" out of the sensitive part of the ear (posterior canal) to a less sensitive location. It is also sometimes called the "canalith repositioning maneuver".</i_keyword>
      <i_keyword>Intervention group 2: Semont Group  is given Semont maneuver in which patient sit on the edge of bed. First patient head is turned 45 degrees to the right and then quickly lie down him on left side. This position is maintained for 30 seconds. And then the patient is quickly move to lie down on the opposite end of the bed. After that return him slowly to sitting and wait a few minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>To compare the effects of Semont and Epley’s maneuver in patients with BPPV using Patient Specific functional scale and Activity based Confidence scale. Timepoint: Single session, before and after treatment. Method of measurement: Patient specific functional scale and Activity based confidence scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>To determine the effects of Semont and Epley’s maneuver in patients with BPPV using Patient Specific functional scale and Activity based confidence scale. Timepoint: Single session, before and after treatment. Method of measurement: Patient specific functional scale and Activity based confidence scale.</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>Shifa Tameer-e-Millat University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-04-01</approval_date>
        <contact_name>Institutional review board and ethical committee shifa tameer-e-millat and shifa international hospi</contact_name>
        <contact_address>Pitras Bukhari Road, Shifa international hospital Ltd. sector h-8/4 Islamabad Islamabad Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
