<?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>IRCT20120910010806N8</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-06-15</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>the effect of the order of Transcranial direct current stimulation and Computer-based Cognitive Rehabilitation on Improving Cognitive Performance and Activities of Daily Living</public_title>
      <acronym>TDCs</acronym>
      <scientific_title>Comparison of the effect of the order of Transcranial direct current stimulation and Computer-based Cognitive Rehabilitation on Improving Cognitive Performance and Activities of Daily Living Patient with Stroke</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/31853</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: The fourth group of this study receives placebo electrical stimulation, As electrodes are first placed on the headAnd the flow is establishedAnd after 30 seconds, the stream fades out, Randomization description: By convenient method the records of inpatients and outpatients stroke patients who referred to the department of the neurology of hospitals of Iran University of Medical Sciences between 1 to 12 months ago were reviewed. Then simple randomize method used. The blind person to the aim of the study, divided the eligible patients  into four groups by randomization digits table, Blinding description: In this study the assessment will be performed by trained assessors who are blind to the study. After completion of the treatment and completing the assessments, the data will be entered into the SPSS and analyzed by the blind person about the four treatment groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Cerebral Vascular Accident. Condition 2: Cerebral Vascular Accident.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Group 1: First tDCS session on c3 or c4, 2 mA currency  for 20 minutes, then computer based cognitive rehabilitation for 30 to 40 minutes, weekly two sessions and ten sessions totally . Intervention 2: Intervention group: Group 2: First, computer based cognitive rehabilitation for 30 to 40 minutes, and then tDCS on c3 or c4, 2 mA currency  for 20 minutes,weekly two sessions and ten sessions totally . Intervention 3: Intervention group:  Group 3: Simultaneously computer based cognitive rehabilitation for 30 to 40 minutes and tDCS on c3 or c4, 2 mA currency  for 20 minutes,weekly two sessions and ten sessions totally . Intervention 4: Control group: Group 4: Simultaneously sham tDCS  in such a way that the electrical current is applied only for 30 seconds, and then the current is disconnected, and the device is placed somewhere away from the patient's vision and computer based cognitive rehabilitation for 30 to 40 minutes, weekly two sessionsand ten sessions totally .</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Susan Samani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 33, East of Zoroaster, above Vali-e-Asr Square, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1413953461</zip>
        <telephone>+98 21 8880 2063</telephone>
        <email>susan.samani@gmail.com</email>
        <affiliation>Institute for Cognitive Science Studies</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Malahat Akbarfahimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Rehabilitation Sciences, Iran University of Medical Sciences, Workers' Street, Shah Nazari Street, Mother's square, Mirdamad, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>15459-13478</zip>
        <telephone>+98 21 2222 7124</telephone>
        <email>rehab@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>schemic stroke in the anterior and medial cerebral arteries or one of the arteries. Neurologist by MRI
No aphasia and associated neurological disorders (Parkinson's, MS, ALS, Alzheimer's disease)
First stroke of the patient and one to twelve months after the stroke
Admission Age Between 20 and 75 Years
At least 9 successful grades literacy</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Not attending two consecutive treatment sessions
Change the medication during the course of the intervention
Create headaches</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G46.0</hc_code>
      <hc_code>G46.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Middle cerebral artery syndrome</hc_keyword>
      <hc_keyword>Anterior cerebral artery syndrome</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: Group 1: First tDCS session on c3 or c4, 2 mA currency  for 20 minutes, then computer based cognitive rehabilitation for 30 to 40 minutes, weekly two sessions and ten sessions totally .</i_keyword>
      <i_keyword>Intervention group: Group 2: First, computer based cognitive rehabilitation for 30 to 40 minutes, and then tDCS on c3 or c4, 2 mA currency  for 20 minutes,weekly two sessions and ten sessions totally .</i_keyword>
      <i_keyword>Intervention group:  Group 3: Simultaneously computer based cognitive rehabilitation for 30 to 40 minutes and tDCS on c3 or c4, 2 mA currency  for 20 minutes,weekly two sessions and ten sessions totally .</i_keyword>
      <i_keyword>Control group: Group 4: Simultaneously sham tDCS  in such a way that the electrical current is applied only for 30 seconds, and then the current is disconnected, and the device is placed somewhere away from the patient's vision and computer based cognitive rehabilitation for 30 to 40 minutes, weekly two sessionsand ten sessions totally .</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>1-Improvement of executive functions: Spatial Span - One Touch Stockings of Cambridge - latency to correct - mean choices to correct - problem solved on first choices - swtiching cost - Congruency cost - Stop Signal task - direction errors -Proportion of successful stop - reaction time. Timepoint: One day before the first intervention session and one week after the tenth intervention session. Method of measurement: Cambridge Neuropsychological Test Automated Battery (CANTAB) test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Activities of daily living: Those are the skills and tasks that a person pays for them throughout the day and forms the daily routines of the individual's life.These activities include dressing and dressing up, eating, brushing, bathing, going to toilet and dressing yourself. instrumental activities of daily living:These activities are self-care assignments that are usually taught in adolescence and require sophisticated thinking skills, such as the organization of skills.And include activities such as financial management, management of the use of vehicles, purchase of food preparation, traffic management and control how the drugs are. Timepoint: An initial assessment one day before the start of intervention and a secondary assessment is performed one week after the end of the tenth session of intervention. Method of measurement: The activities of daily living are assessed by the Barthel index.The instrumental activities of daily living   are evaluated by the Lawton 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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-05-20</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
