<?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>IRCT20191112045415N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-12-08</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Effect of verb treatment on sentence production in aggrammatism</public_title>
      <acronym></acronym>
      <scientific_title>The comparison of effectiveness of regular and irregular past tense treatment on sentence production and neural function in patients with agrammatic aphasia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>6</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/43603</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>aphasia.</hc_freetext>
      <i_freetext>Intervention group: ACTION treatment will be performed on patients with agrammatic aphasia with a focus on verb learning and its tense inflection in sentence structure. The treatment steps are as follows: Stage 1 Syntactic Level: Recovery of nonverbal verbs in sentence context.  a picture is shown with a sentence under it, in which the verb, in infinitival form, is left out.The participant reads the sentence (if necessary with the help of the therapist) and has to fill in the missing verb orally. Step 2: Syntactic-syntactic step: Retrieves the verb in the context of the sentence. As in step 1, but here the verb tense has to be inflected correctly . a picture is shown with a sentence under it, in which the verb, in infinitival form, is left out.The participant reads the sentence (if necessary with the help of the therapist) and has to fill in the missing verb orally. Step 3. Sentence construction: An image is shown to the participant and he or she must make a grammatical sentence..</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Vahid Valinejad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Enghelab square, kargar shomali Blvd, Borhany Alley, Enghelab 5 Dormitory</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>14179-33791</zip>
        <telephone>+98 84 2442 3269</telephone>
        <email>valinejad.vahid@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Vahid Valinejad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Enghelab square, kargar shomali Blvd, Borhany Alley, Enghelab 5 Dormitory</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>14179-33791</zip>
        <telephone>+98 84 2442 3269</telephone>
        <email>valinejad.vahid@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patient symptoms of non-fluent aphasia and aphasia quotient (AQ) between 51 to 75 on the test P-DAB-1 that represents the moderate aphasia
Earn more than 50% on the subscales of Auditory Comprehension and Continuous Instructions on the P-DAB-1 test
Agrammatic sentence production according to descriptive speech (Bird's Nest) and story retelling (three kids) in a way that speech is distorted and non-fluent; the percentage of sentences is reduced, and production of grammatical morphemes and verbs is reduced
Difficulty in the verb tense inflection with less than 50 % in accuracy of regular and irregular verb tense inflection
The ability to read in the subtest of single word reading in  Bilingual Aphasia Test (BAT)
Right-handed patient (using Edinburgh scale)
Patients who are Persian monolingual or are fluent in Persian if they are bilingual
Normal or near normal visual ability
Normal or near normal hearing
Minimum 9th grade education
The patient has a stroke lesion on the left side of the brain, which last at least six months of its occurrence
Aged between 18 - 65 years old</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of neurological and psychological problems, speech and language problems, and learning problems
Patients with apraxia
Patients with Dysarthria in informal assessment
Sign of claustrophobia
Pregnant female subjects
Subjects who have metal prosthesis</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R47.01</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Aphasia</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: ACTION treatment will be performed on patients with agrammatic aphasia with a focus on verb learning and its tense inflection in sentence structure. The treatment steps are as follows: Stage 1 Syntactic Level: Recovery of nonverbal verbs in sentence context.  a picture is shown with a sentence under it, in which the verb, in infinitival form, is left out.The participant reads the sentence (if necessary with the help of the therapist) and has to fill in the missing verb orally. Step 2: Syntactic-syntactic step: Retrieves the verb in the context of the sentence. As in step 1, but here the verb tense has to be inflected correctly . a picture is shown with a sentence under it, in which the verb, in infinitival form, is left out.The participant reads the sentence (if necessary with the help of the therapist) and has to fill in the missing verb orally. Step 3. Sentence construction: An image is shown to the participant and he or she must make a grammatical sentence.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Trained and generalization verb tense inflection score. Timepoint: verb tense inflection assessment for 17 times: 3 baselines, 12 during treatment (once per week for 12 weeks), 14 and 30 days after treatment. Method of measurement: verb tense inflection assessment test.</prim_outcome>
      <prim_outcome>Trained and generalization sentence production score. Timepoint: sentence production assessment for 17 times: 3 baselines, 12 during treatment (once per week for 12 weeks), 14 and 30 days after treatment. Method of measurement: sentence production test.</prim_outcome>
      <prim_outcome>The place of the activated brain area. Timepoint: brain activation imaging 2 times: once pre-treatment and once after treatment. Method of measurement: functional magnetic resonance imaging.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Sentence production score. Timepoint: sentence production assessment for 17 times: 3 baselines, 12 during treatment (once per week for 12 weeks), 14 and 30 days after treatment. Method of measurement: sentence production assessment test.</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>2019-10-22</approval_date>
        <contact_name>Ethics committee of Tehran University of Medical Science</contact_name>
        <contact_address>Floor 13, Block A, Ministry of Health &amp; Medical Education Headquarters, Between Zarafashan &amp; South Falamak, Qods Town, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
