<?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>IRCT20230709058728N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-09-24</date_registration>
      <primary_sponsor>The University of Faisalabad</primary_sponsor>
      <public_title>The effect of vestibular rehabilitation using Epley’s Maneuver in patients with canalithiasis due to forward head posture; a randomized clinical trial</public_title>
      <acronym></acronym>
      <scientific_title>The effect of vestibular rehabilitation using Epley’s Maneuver in patients with canalithiasis due to forward head posture; a randomized clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-03-28</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>48</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71218</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple random sampling via lottery method. The IDs of all the participants were written on the slips of paper having same color and size and mix it up. Then blindfold selection were made.</study_design>
      <phase>0 (exploratory trials)</phase>
      <hc_freetext>Vertigo; dizziness.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Epley’s maneuver contains a sequence of 4 consecutive movements. 45° head rotation towards the affected side in reference to the body is made in sitting, 45° head rotation towards the affected side and slight extension of head below the level of the plinth in supine (the first step), now 45° head rotation towards the healthy side and slight extension of head below the level of the plinth in supine (the second step), 135° head rotation towards the healthy side in position of lateral decubitus also known as 135° sound-ear down position (the third step), the last step is then sitting in the upright position(the fourth step). Intervention 2: Control group: received Vestibular rehabilitation therapy in which participants receive gaze and head stability exercises. Gaze stabilization exercises were performed while participants were seated and the individuals have to follow the card through gaze by moving their eyes and head.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
The effect of vestibular rehabilitation using EPLEY's maneuver in patients with canalithiasis due to forward head posture; A randomized clinical trial

When:
Data will be available after the completion of the study and will remain available till 6 months

To whom:
Data will be available for other people almost 6 months after the completion of study

Conditions:
The data/document could be used by communicating with the principle investigator Maryam Asif

Where to obtain:
Maryam Asif 
drmaryamasifpt@gmail.com

How to obtain:
The data/document could be used by communicating with the principle investigator Maryam Asif

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Asif</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Canal Road, Faisal Town, Faisalabad.</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38800</zip>
        <telephone>+92 41 8750971</telephone>
        <email>drmaryamasifpt@gmail.com</email>
        <affiliation>The University of Faisalabad</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Tayyaba Falak</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faisal Town, West Canal Road</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38800</zip>
        <telephone>+92 41 8750971</telephone>
        <email>tayyabafalak14@gmail.com</email>
        <affiliation>The University of Faisalabad</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Craniovertebral Angle that is less than 50-53 degrees
Gender: Both male and female
Computer/ laptop users
IT students of final year
Positive Dix-Hallpike maneuver
age 20-24</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>24 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>CVA (cerebrovascular accident)
Vestibular migraine
Cervical spondylosis
History of skull fracture
Upper cross syndrome
Already diagnosed with BPPV
Other musculoskeletal conditions
Other neurological conditions
Mentally or emotionally unstable
Carcinoma of brain
ear infections
hypertension</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>H81.10</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Benign paroxysmal 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 group: Epley’s maneuver contains a sequence of 4 consecutive movements. 45° head rotation towards the affected side in reference to the body is made in sitting, 45° head rotation towards the affected side and slight extension of head below the level of the plinth in supine (the first step), now 45° head rotation towards the healthy side and slight extension of head below the level of the plinth in supine (the second step), 135° head rotation towards the healthy side in position of lateral decubitus also known as 135° sound-ear down position (the third step), the last step is then sitting in the upright position(the fourth step)</i_keyword>
      <i_keyword>Control group: received Vestibular rehabilitation therapy in which participants receive gaze and head stability exercises. Gaze stabilization exercises were performed while participants were seated and the individuals have to follow the card through gaze by moving their eyes and head.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Dizziness. Timepoint: Dizziness handicap inventory. Method of measurement: The DHI have 25 items, and a total score of 0-100 points , The patient is asked to answer each question as it pertains to dizziness, specifically considering their condition during the last month. Questions are designed to incorporate functional (F), physical (P), and emotional (E) impacts on disability. Positional (F3) sub-scale shows maximum scoring in BPPV cases.</prim_outcome>
      <prim_outcome>Vertigo. Timepoint: Visual Vertigo Analogue scale. Method of measurement: The VVAS is a visual analog scale that rates the intensity of visual vertigo in 9 challenging situations of visual motions that particularly provoke dizziness.</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>The University of Faisalabad</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-03-25</approval_date>
        <contact_name>The University of Faisalabad</contact_name>
        <contact_address>Canal road, Faisalabad Faisalabad Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
