<?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>IRCT20160131026279N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-09-02</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Effect of rehabilitation and electrical stimulation on treatment of unilateral vestibular impairment</public_title>
      <acronym></acronym>
      <scientific_title>Comparison the effect of galvanic vestibular stimulation combined with conventional vestibular rehabilitation program or virtual reality rehabilitation on cognitive and balance performance of patients with unilateral vestibular impairment</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>52</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/58375</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization method: Individual random assignment to four equal groups with block randomization method using blocks of size 4; Randomization and random sequential allocation: done with Random Allocation Software; Allocation concealment: done with sequentially numbered, sealed, opaque envelopes.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Vestibular disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1 (VRT): receiving vestibular rehabilitation program (Cooksey-Cawthorne exercises), 30 min, twice a day, 4 weeks. Intervention 2: Intervention group 2 (VRT+ GVS): receiving vestibular rehabilitation program with noisy galvanic vestibular stimulation (subliminal, 20 min, once a week, 3 weeks). Intervention 3: Intervention group 3 (VR): receiving virtual-vestibular rehabilitation (eight 45-minute sessions of Nintendo Wii fit plus exercises, twice a week, 4 weeks). Intervention 4: Intervention group 4 (VR+GVS): receiving virtual-vestibular rehabilitation and GVS.</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:
Reporting as a PhD dissertation and papers

When:
2023 and after

To whom:
All people

Conditions:
Dissertation: In accordance with Tehran University of Medical Sciences copyright 
Paper: In accordance with the journal's policies to access the published paper

Where to obtain:
Dissertation: The library of the School of Rehabilitation, TUMS
Papers: Databases

How to obtain:
For the dissertation, studying in the library
For papers depends on the journal's policy.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mansoureh Adel Ghahraman</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Enghelab Ave.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1148956111</zip>
        <telephone>+98 21 7753 4364</telephone>
        <email>madel@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mansoureh Adel Ghahraman</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Enghelab Ave.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1148956111</zip>
        <telephone>+98 21 7753 4364</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>Diagnosed uncompensated chronic unilateral vestibular disorder (such as Vestibular neuritis) with canal paralysis&gt; 25% using caloric test,
Age range of 20-50 years,
No benign paroxysmal positional vertigo,
Complaints of vertigo and imbalance during movement,
No central nervous system involvement,
No previous Vestibular rehabilitation program,
Normal or corrected visual acuity with glasses (20/20) using the Snellen chart in order to view the target point on the vHIT test and perform cognitive tests,
Normal hearing ability or corrected hearing loss with hearing aid in order to hear the stimulus in the force plate test,
Having diploma at least.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Drug consumptions that result in suppressing vestibular system compensation
Neck pain and limited range of motion of the neck
Alcoholism or addiction
Orthopedic problems in the last 6 months
Obvious lower extremity deformities such as scoliosis and kyphosis according to observation of a physiotherapist
Rheumatic and/or metabolic diseases
Professionalism in various fields of sports, art and music because of their impact on the cognitive fields</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>H81</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Disorders of vestibular function</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1 (VRT): receiving vestibular rehabilitation program (Cooksey-Cawthorne exercises), 30 min, twice a day, 4 weeks</i_keyword>
      <i_keyword>Intervention group 2 (VRT+ GVS): receiving vestibular rehabilitation program with noisy galvanic vestibular stimulation (subliminal, 20 min, once a week, 3 weeks)</i_keyword>
      <i_keyword>Intervention group 3 (VR): receiving virtual-vestibular rehabilitation (eight 45-minute sessions of Nintendo Wii fit plus exercises, twice a week, 4 weeks)</i_keyword>
      <i_keyword>Intervention group 4 (VR+GVS): receiving virtual-vestibular rehabilitation and GVS</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Dizziness Handicap Inventory score. Timepoint: Before and after intervention. Method of measurement: Dizziness Handicap Inventory.</prim_outcome>
      <prim_outcome>Response latency. Timepoint: Before and after intervention. Method of measurement: Choice reaction time test.</prim_outcome>
      <prim_outcome>Response accuracy. Timepoint: Before and after intervention. Method of measurement: Choice reaction time test.</prim_outcome>
      <prim_outcome>Response latency. Timepoint: Before and after intervention. Method of measurement: Visual Stroop test.</prim_outcome>
      <prim_outcome>Response accuracy. Timepoint: Before and after intervention. Method of measurement: Visual Stroop test.</prim_outcome>
      <prim_outcome>Interference score. Timepoint: Before and after intervention. Method of measurement: Visual Stroop test.</prim_outcome>
      <prim_outcome>Working memory span. Timepoint: Before and after intervention. Method of measurement: Backward digit span test.</prim_outcome>
      <prim_outcome>Total number of correct words. Timepoint: Before and after intervention. Method of measurement: Verbal fluency test.</prim_outcome>
      <prim_outcome>Response accuracy. Timepoint: Before and after intervention. Method of measurement: Serial sevens subtraction task.</prim_outcome>
      <prim_outcome>Total test time. Timepoint: Before and after intervention. Method of measurement: Serial sevens subtraction task.</prim_outcome>
      <prim_outcome>Visuospatial span length. Timepoint: Before and after intervention. Method of measurement: Corsi block test.</prim_outcome>
      <prim_outcome>Treatment benefit score. Timepoint: Before and after intervention. Method of measurement: Treatment benefit questionnaire.</prim_outcome>
      <prim_outcome>Vestibulo-ocular reflex gain. Timepoint: Before and after intervention. Method of measurement: video head impulse test (vHIT).</prim_outcome>
      <prim_outcome>Frequency of overt and covert saccades. Timepoint: Before and after intervention. Method of measurement: video head impulse test (vHIT).</prim_outcome>
      <prim_outcome>Displacement of center of pressure in both anterior-posterior and medial-lateral directions. Timepoint: Before and after intervention. Method of measurement: Static posturography on force-plate.</prim_outcome>
      <prim_outcome>Velocity of displacement of center of pressure in both anterior-posterior and medial-lateral directions. Timepoint: Before and after intervention. Method of measurement: Static posturography on force-plate.</prim_outcome>
      <prim_outcome>Phase plane. Timepoint: Before and after intervention. Method of measurement: Static posturography on force-plate.</prim_outcome>
      <prim_outcome>Displacement of center of pressure in both anterior-posterior and medial-lateral directions in anticipation, weight transfer, and locomotion. Timepoint: Before and after intervention. Method of measurement: Dynamic posturography on force-plate.</prim_outcome>
      <prim_outcome>Velocity of center of pressure displacement in both anterior-posterior and medial-lateral directions in anticipation, weight transfer, and locomotion. Timepoint: Before and after intervention. Method of measurement: Dynamic posturography on force-plate.</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</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-06-08</approval_date>
        <contact_name>School of Nursing and Midwifery &amp; Rehabilitation - Tehran University of Medical Sciences</contact_name>
        <contact_address>Enghelab Ave. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-02-09</approval_date>
        <contact_name>School of Nursing and Midwifery &amp; Rehabilitation - Tehran University of Medical Sciences</contact_name>
        <contact_address>Enghelab Ave. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
