<?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>IRCT20180515039676N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-12-11</date_registration>
      <primary_sponsor>University of social welfare and rehabilitation sciences</primary_sponsor>
      <public_title>"Comparing Cognitive Orientation to Daily Occupational Performance with Motivational Interviewing on occupational performance in stroke patients"</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effect of “Cognitive Orientation to Daily Occupational Performance” (CO-OP) with “Motivational Interviewing” (MI) on occupational performance in chronic stroke patients: a randomized controlled trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/74170</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block random allocation method is used for data allocation. This allocation is done in several steps. First, using the website www.sealedenvelope.com, a random sequence with blocks of six is created. Then, to hide the random allocation, sealed and waxed opaque envelopes are used in a random sequence. Based on the size of the research sample, a number of envelopes with aluminum wrapping (in view of the lack of clarity of the contents of the envelopes), preparation and each of the random sequences created on a card are recorded and the cards inside the envelopes are called They are placed in order. In order to preserve the random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed in a box in order. At the time of registration of the participants, according to the order of entry of the eligible participants to the study, one of the letter envelopes will be opened and the assigned group of that participant will be revealed, Blinding description: This will be a single-blind study. It should be noted that all evaluations are done by a trained evaluator therapist who does not know about the allocation of people in each of the groups, which is different from the examiner who performs the intervention in three groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>stroke.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Cognitive Orientation to Daily Occupational Performance (CO-OP). Intervention 2: Intervention group: Motivational Interviewing (MI). Intervention 3: Control group: Usual treatment (occupational therapy).</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All data is potentially shareable after de-identifying individuals.

When:
The access period starts 6 months after the results are published.

To whom:
The data will be available to researchers working in academic and scientific institutions and rehabilitation professionals in clinical settings.

Conditions:
Providing the medical system card to ensure the clinical competence of people to provide services.

Where to obtain:
Sending an email to an address named Shiva Abedi, sending an SMS to the contact number of Shiva Abedi, making a call to the number of Shiva Abedi, visiting in person Dr. Nazila Akbarfahimi at the University of Social Welfare and Rehabilitation Sciences.

How to obtain:
First, the applicant must send a request to receive the documents to an email address named Shiva Abedi, if there is no response after 10 days, send an SMS or call the contact number of Shiva Abedi, then the responsible person ( Abedi) makes the necessary arrangements to send the documents to the applicant. If the responsible person (Abedi) did not respond within 7 days after sending the text message and making the call, the requesting person can send his request to the email address of Dr. Nazila Akbarfahimi.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shiva Abedi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bagh Goldaste Ave., Goldis Center, Isfahan Town</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8145613353</zip>
        <telephone>+98 31 3224 5327</telephone>
        <email>shiva.abedi.ot@gmail.com</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nazila Akbarfahimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>kodakyar Ave., daneshjo Blvd.,Evin., Tehran Town</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985713871</zip>
        <telephone>+98 21 2218 0083</telephone>
        <email>fahimi1970@yahoo.com</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Be a volunteer to enter the study (completion of the consent form)
Chronic ischemic stroke (at least one year has passed since the stroke) diagnosed by a neurologist.
Age 18 years and above
Sufficient cognitive ability (minimum score of 22 on the Montreal Cognitive Test)
Scores 5-18 in the Beck Depression Questionnaire (short form) (minimum level of depression or mild depression to moderate depression)
Being in stage 3 and above Brunnstrom
Absence of disorder in verbal understanding such as Wernicke's and Global aphasia.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patient's non-cooperation during the intervention or unwillingness to continue cooperation in the intervention2- Failure to follow up the patient to participate in at least two treatment sessions3- Reoccurrence of stroke</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>164</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Stroke, not specified as hemorrhage or infarction</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>Intervention group: Cognitive Orientation to Daily Occupational Performance (CO-OP)</i_keyword>
      <i_keyword>Intervention group: Motivational Interviewing (MI)</i_keyword>
      <i_keyword>Control group: Usual treatment (occupational therapy)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Occupational performance. Timepoint: Before the intervention, five weeks and one month after the intervention. Method of measurement: Canadian Occupational Performance Measure Scale (COPM), Performance Quality Rating Scale (PQRS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Self-efficacy. Timepoint: Before the intervention, five weeks and one month after the intervention. Method of measurement: General Self-Efficacy Scale (GSE-10).</sec_outcome>
      <sec_outcome>Independence in daily activities of life. Timepoint: Before the intervention, five weeks and one month after the intervention. Method of measurement: Functional Independence Measurement (FIM).</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>2023-08-28</approval_date>
        <contact_name>Ethics committee of  University of Social Welfare and Rehabilitation Sciences</contact_name>
        <contact_address>kodakyar Ave., daneshjo Blvd.,Evin Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
