<?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>IRCT20230814059142N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-08-21</date_registration>
      <primary_sponsor>Institute for Cognitive Science Studies</primary_sponsor>
      <public_title>Developing a Rehabilitation Program in Patients with Stroke</public_title>
      <acronym></acronym>
      <scientific_title>Developing a Group Attention Rehabilitation Program and Investigating its Efficacy on Attention and Emotional Outcomes in Patients with Ischemic Stroke</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72077</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Simple Randomization, Based on the Last Digit of the National Identity Code of Each Participant (Even or Odd); Even Numbers will be in the Intervention Group and Odd Numbers will be in the Control Group, Blinding description: The Main Purpose of this Study and the Provided Interventions are Not Directly Told to the Participants; They are Only Told that the Interventions They Receive are Aimed to Improve their Quality of Life after Stroke. Also, the Participants of Each Group will Not be in Contact with the Other Group. Moreover, the Analyst does Not Know the code of Intervention Which would be Assigned to Each Participant.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Ischemic Stroke.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Group Attention Rehabilitation Program. Intervention 2: Control group: General Education about the Disease and its Course.</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>Sajjad Montazerghaem</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Institute for Cognitive Science Studies, Cognitive Science Blvd, Edalat Roundabout, Pardis</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1658344575</zip>
        <telephone>+98 21 7629 1130</telephone>
        <email>sajjad.montazerghaem@gmail.com</email>
        <affiliation>Institute for Cognitive Science Studies</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Javad Hatami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Institute for Cognitive Science Studies, Cognitive Science Blvd, Edalat Roundabout, Pardis</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1658344575</zip>
        <telephone>+98 21 7629 1130</telephone>
        <email>hatamijm@gmail.com</email>
        <affiliation>Institute for Cognitive Science Studies</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having Diagnostic Criteria for Ischemic Stroke
Signing the Ethical Consent Form to Participate in the Study (by the person himself/herself or his/her First-Degree Companions)
Age between 18 and 65 years
Being in the Sub-Acute and Chronic Stage of Stroke, according to Specialist Diagnosis
Having the Ability to Read and Write in Persian
Obtaining a score of 22 or lower in Montreal Cognitive Assessment (MoCA)</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Obtaining a score of 10 or lower in Montreal Cognitive Assessment (MoCA)
Having an Unstable Medical Condition, as Diagnosed by a Specialist (eg, Epilepsy or Uncontrolled Diabetes)
Having Other Severe Neuro-Cognitive Disorders, as Diagnosed by a Specialist (eg, Aphasia)
Drug or Alcohol Addiction
Having Movement Limitations that Prevent Training and Intervention Exercises
Getting Another Cognitive Rehabilitation Method</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I63</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Cerebral infarction</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Group Attention Rehabilitation Program</i_keyword>
      <i_keyword>Control group: General Education about the Disease and its Course</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sustained Attention. Timepoint: Before the Intervention, After the Intervention, 1 Month after the Intervention. Method of measurement: Integrated Visual and Auditory Continuous Performance Test - 2 (IVACPT - 2) and Trail Making Test - Part A (TMT-A).</prim_outcome>
      <prim_outcome>Selective Attention. Timepoint: Before the Intervention, After the Intervention, 1 Month after the Intervention. Method of measurement: Stroop Test.</prim_outcome>
      <prim_outcome>Alternating Attention. Timepoint: Before the Intervention, After the Intervention, 1 Month after the Intervention. Method of measurement: Trail Making Test - Part B (TMT-B).</prim_outcome>
      <prim_outcome>Divided Attention. Timepoint: Before the Intervention, After the Intervention, 1 Month after the Intervention. Method of measurement: Letter-Number Sequencing Test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Anxiety. Timepoint: Before the Intervention, After the Intervention, 1 Month after the Intervention. Method of measurement: Beck Anxiety Inventory (BAI).</sec_outcome>
      <sec_outcome>Depression. Timepoint: Before the Intervention, After the Intervention, 1 Month after the Intervention. Method of measurement: Beck Depression Inventory (BAI).</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>Institute for Cognitive Science Studies</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-06-10</approval_date>
        <contact_name>Research Ethics Committee of Institute for Cognitive Science Studies</contact_name>
        <contact_address>Institute for Cognitive Science Studies, Cognitive Science Blvd, Edalat Roundabout, Pardis Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
