<?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>IRCT20221016056197N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-01-29</date_registration>
      <primary_sponsor>University of social welfare and rehabilitation sciences</primary_sponsor>
      <public_title>Auditory Spatial Attention Training in Stroke</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Auditory Spatial Attention Training on Auditory Spatial and Dichotic Processing in Subjects with Right Brain Stroke</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-02-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>8</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66338</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: This study will investigate a number of stroke patients in two groups. One group (intervention group) receives rehabilitation and the other group (control group) don't receive any intervention, Randomization description: For random allocation, we will use 8 cards A (treatment group) and 8 cards B (control group) and put them in 16 envelopes with the same shape that is not clear inside them. After reshuffling them several times, we will mark them whit serial numbers from 1 to 16. when each participant enters, an envelope is opened and the patient group is determined.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Stroke.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: auditory lateralization training is performed for 12 sessions of 45 minutes. Auditory stimulus is high-pass and low-pass noise with a cut-off frequency of 2 kHz, which were simulated in 9 hypothetical spatial locations (in the form of 9 speakers in a semicircular horizontal plane) by interaural time difference (ITD) under MATLAB software. The sounds were presented binaurally with different ITDs (0, ±220, ±440, ±660 and ±880 microseconds) at comfortable level via headphones, to induce a sense of displacement of the sound source. Positive and negative numbers and zero indicate stimulus presentation from the right and left angles, and center position, respectively. The subjects should lateralize the sounds and point to a schematic picture of speakers in front of them with right hand. Intervention 2: Control group: they do not receive any intervention.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Eshaghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Koudakyar St., Daneshjoo Blvd., Evin</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985713871</zip>
        <telephone>+98 21 2218 0066</telephone>
        <email>zah.eshaghi@uswr.ac.ir</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Eshaghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Koudakyar St., Daneshjoo Blvd., Evin</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985713871</zip>
        <telephone>+98 21 2218 0066</telephone>
        <email>zah.eshaghi@uswr.ac.ir</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Consent to participate in the study
Right Hemisphere Stroke Diagnosed by a Neurologist
Unilateral Spatial Neglect Diagnosed by a Neurologist
Stability of the Medical Condition after the Acute Phase of Stroke
Right-Handedness
Normal Hearing (Average Hearing Thresholds of Frequencies 500, 1000 and 2000 Hz Less Than 25 dB HL in Both Ears and Symmetrical Hearing)</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Other Neurological Diseases
Cognitive Problems Based on Persian version of Mini–Mental State Examination (MMSE) (Minimum Score of 21)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>stroke</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>stroke</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: auditory lateralization training is performed for 12 sessions of 45 minutes. Auditory stimulus is high-pass and low-pass noise with a cut-off frequency of 2 kHz, which were simulated in 9 hypothetical spatial locations (in the form of 9 speakers in a semicircular horizontal plane) by interaural time difference (ITD) under MATLAB software. The sounds were presented binaurally with different ITDs (0, ±220, ±440, ±660 and ±880 microseconds) at comfortable level via headphones, to induce a sense of displacement of the sound source. Positive and negative numbers and zero indicate stimulus presentation from the right and left angles, and center position, respectively. The subjects should lateralize the sounds and point to a schematic picture of speakers in front of them with right hand.</i_keyword>
      <i_keyword>Control group: they do not receive any intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Number of auditory lateralization errors. Timepoint: Before the intervention, after the last session (0 to 48 hours after the last session) and one month later. Method of measurement: Interaural Time  and Intensity Difference (ITD and IID) auditory lateralization test.</prim_outcome>
      <prim_outcome>Spatial monosyllabic word recognition score in noise. Timepoint: Before the intervention, after the last session (0 to 48 hours after the last session) and one month later. Method of measurement: Auditory lateralization of monosyllabic words in noise test.</prim_outcome>
      <prim_outcome>Right and left ear scores in Randomized Dichotic Digit Test (RDDT). Timepoint: Before the intervention, after the last session (0 to 48 hours after the last session) and one month later. Method of measurement: Persian version of randomized dichotic digit test.</prim_outcome>
      <prim_outcome>Laterality index in Randomized Dichotic Digit Test (RDDT). Timepoint: Before the intervention, after the last session (0 to 48 hours after the last session) and one month later. Method of measurement: Persian version of randomized dichotic digit test.</prim_outcome>
      <prim_outcome>Speech , Spatial , Quality of Hearing Scale (SSQ) questionnaire score. Timepoint: Before the intervention, after the last session (0 to 48 hours after the last session) and one month later. Method of measurement: Speech , Spatial , Quality of Hearing Scale (SSQ) questionnaire.</prim_outcome>
      <prim_outcome>Number of auditory lateralization errors. Timepoint: Before the intervention, after the last session (0 to 48 hours after the last session) and one month later. Method of measurement: Auditory lateralization of monosyllabic words in noise test.</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>University of social welfare and rehabilitation sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-01-14</approval_date>
        <contact_name>Ethics Committee of the University of Social Welfare and Rehabilitation Sciences</contact_name>
        <contact_address>Koudakyar St., Daneshjoo Blvd., Evin Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
