<?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>IRCT20200114046134N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-07-29</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the effectiveness of speech therapy and Arm Ability Training (AAT) in aphasia</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effectiveness of speech therapy interventions and Arm Ability Training (AAT) on naming skill, sentence comprehension, memory and hand dexterity in people with mild to moderate aphasia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-09-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/45038</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Simple randomization using a table of random numbers, Blinding description: In this study, due to the inability to hide the type of treatment from the samples and therapists, evaluators will not know the type of treatment that samples receive when assessing the skills before the start of 
treatment and on days 7,14 and 21 after starting treatment.
Analysts will also not know the type of treatment that samples receive when analyzing the data from the evaluation of the skills.</study_design>
      <phase>N/A</phase>
      <hc_freetext>aphasia.</hc_freetext>
      <i_freetext>Intervention 1: First intervention group: nine sessions of speech therapy and each session lasts for 40 minutes. After evaluating the patient, each of the different levels of language, including semantics, phonology, morphology and syntax, reading and writing is targeted according to the degree of damage in each person. Intervention 2: Second intervention group: nine sessions of Arm Ability Training (AAT) and each session lasts for 40 minutes. Due to the individual limitations, eight-step exercises are performed with the aim of increasing speed, accuracy and coordination. Intervention 3: Third intervention group: nine speech therapy and Arm Ability Training (AAT) are simultaneous, 20 minutes of speech therapy sessions and 20 minutes of Arm Ability Training sessions.</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 There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Reihane Sabermoghadam Majidzade</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 15 , Samane Ave. Ferdowsi Blvd.</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9197989735</zip>
        <telephone>+98 51 3763 6953</telephone>
        <email>sabermr971@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sobhani-rad Davood</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Paramedicine school, Mashhad University of Medical Science</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177948964</zip>
        <telephone>+98 51 3884 6715</telephone>
        <email>SobhaniD@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Confirmation of lesion in frontal and temporal lobes of left hemisphere using Magnetic Resonance Imaging (MRI) findings of brain/ The right hand is the recipient/ Confirmation of impairment in language skills (comprehension and expression) through speech therapy using aphasia test of Dr Nilipour/ Mild to moderate confirmation of aphasia by speech therapy using Dr Nilipour aphasia test/ Mild to moderate of mental status by MiniMental Status Evaluation (MMSE) test/ Assessment of right-hand motor weakness by a physiotherapist/ At least one month to two years after stroke/ Patients with age spectrum 35-70/ Patients' satisfaction and willingness to enter the study</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Severe upper extremity disorders/ Psychiatric symptoms such as mood and emotional disorders, sleep disorders, depression, cognitive disorders, etc./ Chronic liver, kidney and heart disease/ Progressive diseases/ Subsequent strokes/ Patient non-cooperation</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>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First intervention group: nine sessions of speech therapy and each session lasts for 40 minutes. After evaluating the patient, each of the different levels of language, including semantics, phonology, morphology and syntax, reading and writing is targeted according to the degree of damage in each person.</i_keyword>
      <i_keyword>Second intervention group: nine sessions of Arm Ability Training (AAT) and each session lasts for 40 minutes. Due to the individual limitations, eight-step exercises are performed with the aim of increasing speed, accuracy and coordination.</i_keyword>
      <i_keyword>Third intervention group: nine speech therapy and Arm Ability Training (AAT) are simultaneous, 20 minutes of speech therapy sessions and 20 minutes of Arm Ability Training sessions.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Score of naming skill. Timepoint: Before starting the intervention and 7,14 and 21 days after starting the treatment. Method of measurement: Subtest of picture naming from Dr. Nilipour's set of aphasia batteries.</prim_outcome>
      <prim_outcome>Score of sentences comprehension. Timepoint: Before starting the intervention and 7,14 and 21 days after starting the treatment. Method of measurement: Subtest of sentences comprehension from a Bilingual Aphasia Test (BAT).</prim_outcome>
      <prim_outcome>Score of memory skill. Timepoint: Before starting the intervention and 7, 14 and 21 days after starting treatment. Method of measurement: Wechesler test.</prim_outcome>
      <prim_outcome>Hand dexterity. Timepoint: Before starting the intervention and 7, 14 and 21 days after starting treatment. Method of measurement: Test d'Evaluation des Membres suprrieurs des Personnes Agres (TEMPA).</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-07-19</approval_date>
        <contact_name>Ethics committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Across the No. 18 ,Daneshgah Ave Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
