<?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>IRCT20180517039699N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-07-08</date_registration>
      <primary_sponsor>University of social welfare and rehabilitation sciences</primary_sponsor>
      <public_title>The effect of cognitive rehabilitation based on information processing speed on occupational performance in people with Multiple Sclerosis</public_title>
      <acronym></acronym>
      <scientific_title>The effect of cognitive rehabilitation based on information processing speed on occupational performance in people with Multiple Sclerosis (MS)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-07-07</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/31305</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Supportive, Randomization description: Patients in two Rofaydeh and Sina centers are randomly divided into control and intervention groups ( refer odd days to Sina hospital for control group and refer even days to Rofaydeh hospital for intervention group). This division was done by draw with cup, Blinding description: َAfter receiving consent from patients, the way of intervention will be explained to them. But the impact of intervention on evaluation tests and mobility and balance will not be mentioned.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Multiple sclerosis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention group will receive a cognitive rehabilitation program based on the information processing speed through the Can Tab system for 12 sessions. They will also receive common therapies of occupational therapy that include flexibility and balance exercises. Intervention 2: Control group: The control group will receive common therapies of occupational therapy that include  include flexibility and balance exercises for 12 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>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>Zahra Yaghoobi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 55 , Sadaf Town., Nakhl Ave., Artesh Hwy</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1955756753</zip>
        <telephone>+98 21 2244 1197</telephone>
        <email>Z.yaghoobi1993@gmail.com</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Yaghoobi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 55 , Sadaf Town., Nakhl Ave., Artesh Hwy</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1955756753</zip>
        <telephone>+98 21 2244 1197</telephone>
        <email>Z.yaghoobi1993@gmail.com</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The person would be willing to participate in the research.
The person has a definite diagnosis of MS by a specialist.
The person has an EDSS score of 5 down.
The person has a FSS score of 9-35.
The person can work with the camputer.
The person has no other neurological diseases.
The person has not taken corticosteroids 28 days before the intervention.
The person has no psychological disorders.
The age of the person is 20 to 60 years.
Gender of patients has no limit.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G35</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Multiple sclerosis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The intervention group will receive a cognitive rehabilitation program based on the information processing speed through the Can Tab system for 12 sessions. They will also receive common therapies of occupational therapy that include flexibility and balance exercises.</i_keyword>
      <i_keyword>Control group: The control group will receive common therapies of occupational therapy that include  include flexibility and balance exercises for 12 sessions.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Balance score in the Balance Evaluation System Test. Timepoint: The balance will be evaluated before the beginning intervention, after the end of intervention and two months after the end of intervention. Method of measurement: The Balance Evaluation System Test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The information processing speed score in Paced Auditory Serial Addition Test (PASAT). Timepoint: The information processing speed will be evaluated before the beginning intervention, after the end of intervention and two months after the end of intervention. Method of measurement: The Paced Auditory Serial Addition Test.</sec_outcome>
      <sec_outcome>The information processing speed score in the Symbol Digit Modalities Test (SDMT). Timepoint: The information processing speed will be evaluated before the beginning intervention, after the end of intervention and two months after the end of intervention. Method of measurement: The Symbol Digit Modalities Test (SDMT).</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>2018-02-26</approval_date>
        <contact_name>Ethics committee of University of Social Welfare and Rehabilitation Sciences</contact_name>
        <contact_address>Koudakyar dead end, Daneshjou blvd, Evin, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
