<?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>IRCT20210621051643N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-06-22</date_registration>
      <primary_sponsor>University of social welfare and rehabilitation sciences</primary_sponsor>
      <public_title>Investigating effects of CO-OP approach on people with Multiple Sclerosis</public_title>
      <acronym></acronym>
      <scientific_title>Comparing effects of Cognitive Orientation to daily Occupational Performance (CO-OP) approach and exercise training on participation, and fatigue in people with Multiple Sclerosis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-07-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/56983</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: we use simple sampling method and simple randomization for allocation of samples into the two group in the present study. For this purpose, before starting the study, a sequence of letters a and b (so that both are equal) is created through randomization.com, according to the sample size. After the start of the study, each participant who met the entry requirements will receive a number based on the time of entry into the study and will receive intervention a or b from a pre-prepared sequence list, Blinding description: The people in charge of the initial and final evaluations as well as the people in charge of data analysis are not aware of the category of participants. Depending on the nature of the study, researchers and participants will be aware of the type of categorization.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Multiple Sclerosis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The CO-OP approach is implemented in 10 sessions. In the first session, performance goals are determined by the authorities using the COPM questionnaire. The therapist then teaches the general problem-solving strategies (goal, plan, execution, check) and how to use field-specific strategies to design and execute the plan and achieve the intended goal. Then, for example, an experimental goal is selected and the general and specific strategies of the field for that goal are practiced with the authorities. From the third session onwards, work on the selected goals of the clients begins. The client plans for its own purposes. The therapist, as an active observer, guides the client through guided discovery, if, given his or her expertise, the program is likely to pose a risk to the client or contain items that make it impossible to reach the target. Guides. Upon entering the program implementation section, dynamic activity analysis is performed by the therapist to identify the needs and obstacles of program implementation at each stage and eliminate them using field-specific cognitive strategies. Intervention 2: Control group: Participants in the control group will receive stretching exercises, strengthening exercises and balance exercises for 6 weeks, 3 sessions per week and a total of 18 sessions of 45 minutes. These exercises will be performed in the clinic. At the discretion of experts, the type of exercise and the duration and intensity of each exercise may vary according to the circumstances of each client.</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 Since the all rights of this study are at the disposal of the University of Social Welfare and Rehabilitation Sciences, any decision regarding the publication of data is at the disposal of this university.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyed Ali Hosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>kodakyar Ave., daneshjo Blvd.,Evin, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985713871</zip>
        <telephone>+98 21 2218 0083</telephone>
        <email>alihosse@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</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985713831</zip>
        <telephone>+98 21 2218 0037</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>Diagnosis of multiple sclerosis by a neurologist
Age between 18-50 years
EDSS score between 3 and 5.5
Score more than 26 in the MoCA assessment</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Recurrence of symptoms or the onset of a new attack during the intervention period
History of receiving CO-OP treatment or similar treatments
Existence of neurological, rheumatic or orthopedic disorders that interfere with treatment</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 CO-OP approach is implemented in 10 sessions. In the first session, performance goals are determined by the authorities using the COPM questionnaire. The therapist then teaches the general problem-solving strategies (goal, plan, execution, check) and how to use field-specific strategies to design and execute the plan and achieve the intended goal. Then, for example, an experimental goal is selected and the general and specific strategies of the field for that goal are practiced with the authorities. From the third session onwards, work on the selected goals of the clients begins. The client plans for its own purposes. The therapist, as an active observer, guides the client through guided discovery, if, given his or her expertise, the program is likely to pose a risk to the client or contain items that make it impossible to reach the target. Guides. Upon entering the program implementation section, dynamic activity analysis is performed by the therapist to identify the needs and obstacles of program implementation at each stage and eliminate them using field-specific cognitive strategies.</i_keyword>
      <i_keyword>Control group: Participants in the control group will receive stretching exercises, strengthening exercises and balance exercises for 6 weeks, 3 sessions per week and a total of 18 sessions of 45 minutes. These exercises will be performed in the clinic. At the discretion of experts, the type of exercise and the duration and intensity of each exercise may vary according to the circumstances of each client.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Participation and Satisfaction in Activity of Daily Living (ADL). Timepoint: Before the intervention ,After the intervention, follow-up period of 3 months. Method of measurement: Canadian Occupational Performance Measure (COPM).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Depression score. Timepoint: Before intervention, after intervention, 3-month follow-up period. Method of measurement: Beck Depression Inventory II (BDI-II).</sec_outcome>
      <sec_outcome>Quality of life score. Timepoint: Before intervention, after intervention, 3-month follow-up period. Method of measurement: Multiple Sclerosis Impact Scale (MSIS-29).</sec_outcome>
      <sec_outcome>Social participation. Timepoint: Before intervention, after intervention, 3-month follow-up period. Method of measurement: Community Integration Questionnaire (CIQ).</sec_outcome>
      <sec_outcome>Intensity and effect of fatigue. Timepoint: Before intervention, after intervention, 3-month follow-up period. Method of measurement: Fatigue Impact Scale (FIS) &amp; Fatigue Severity Scale (FSS).</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>2020-06-22</approval_date>
        <contact_name>Ethics committee of َUniversity 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>
