<?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>IRCT20210901052356N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-09-20</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Investigating effects of CO-OP approach in Individuals with Parkinson’s Disease</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of Cognitive Orientation to daily Occupational Performance (CO-OP) on Satisfaction and Occupational Performance in Individuals with Parkinson’s Disease</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-09-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/58501</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will select by convenience sampling. we use simple randomization for allocation of samples into the control and CO-OP group. For this purpose, before starting the intervention, through the site randomization.com, according to the sample size, a sequence of placing participants in two groups ( both are equal) is created. After the start of the study, each participant who was eligible to enter the study will receive a control or co-op intervention from a pre-prepared sequence list, Blinding description: Participants will not be aware of the group that they are entered. The assessments will be performed by participants and trained assessor who are blind to the study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Parkinson's disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention group receives the CO-OP approach in 12 sessions of 45-60 minutes and 2 sessions per week. This approach has a specific protocol. The first stage is preparation phase. In this stage, the necessary prerequisites for this approach are checked in the clients and also the purpose of treatment is given to the clients. The first session will be after the preparation phase and is evaluation session. In this session, participants select three performance goals based on the Canadian occupational performance measure Scale (COPM), And they score satisfaction and performance of three goals based on a ten-point scale. The second session will give the necessary explanations about the global cognitive strategy (Goal-Plan-Do-Check) to the clients, the focus of this session is on teaching this global strategy. Sessions three to eleven people acquire skills using these strategies, in these sessions the focus is on learning skills, in these sessions, dynamic performance analysis, guided discovery and the Enabling principles are used continuously, and session twelve Assessments are also performed again. Intervention 2: Control group: Patients in the control group received conventional occupational therapy. Evidence suggests that these interventions often include stretching and strengthening exercises, improving postural control, improving balance, relaxation techniques, breathing exercises, and gait training.</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:
Article

When:
March 2022

To whom:
The researcher and occupational therapists

Conditions:
Other research, critics, check and clinical usage

Where to obtain:
Tehran university of Medical Science, School of Rehabilitation Sciences, Occupational Therapy department

How to obtain:
The data and results of the study are available in the final version and are available at the Faculty of Rehabilitation.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Atefeh Taheri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran University of Medical Sciences - School of Rehabilitation, Enghelab St, Pich-e-Shemiran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1148965111</zip>
        <telephone>+98 913 577 7223</telephone>
        <email>Taheri.atefeh.ot@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Seyedeh tahmineh mousavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran University of Medical Sciences, School of Rehabilitation, Occupational Therapy department, Enghelab street, Piche-shemiran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1148965111</zip>
        <telephone>+98 21 7753 4133</telephone>
        <email>t.mousavi@alumni.ubc.ca</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosis of Parkinson’s Disease  by a neurologist
Hoehn and Yahr scale score between stages 1-3
A minimum score of 16 out of 30 on the Montreal Test
No other neurological or psychological problems
Not having a verbal problem
And the ability to understand the global strategy of the  CO-OP approach</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Comorbidity with cognitive impairments such as: Alzheimer, stroke, brain injury, multiple sclerosis, etc.
Lack of cooperation and willingness to continue cooperation</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G20</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Parkinson's disease</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 receives the CO-OP approach in 12 sessions of 45-60 minutes and 2 sessions per week. This approach has a specific protocol. The first stage is preparation phase. In this stage, the necessary prerequisites for this approach are checked in the clients and also the purpose of treatment is given to the clients. The first session will be after the preparation phase and is evaluation session. In this session, participants select three performance goals based on the Canadian occupational performance measure Scale (COPM), And they score satisfaction and performance of three goals based on a ten-point scale. The second session will give the necessary explanations about the global cognitive strategy (Goal-Plan-Do-Check) to the clients, the focus of this session is on teaching this global strategy. Sessions three to eleven people acquire skills using these strategies, in these sessions the focus is on learning skills, in these sessions, dynamic performance analysis, guided discovery and the Enabling principles are used continuously, and session twelve Assessments are also performed again.</i_keyword>
      <i_keyword>Control group: Patients in the control group received conventional occupational therapy. Evidence suggests that these interventions often include stretching and strengthening exercises, improving postural control, improving balance, relaxation techniques, breathing exercises, and gait training.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Performance and satisfaction scores of client-chosen goal. Timepoint: pretest , post test and follow-up (one months after last session). Method of measurement: Canadian Occupational Performance Measurement (COPM).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Goal Attainment. Timepoint: Pretest, post test and follow-up. Method of measurement: Goal Attainment Scale (GAS).</sec_outcome>
      <sec_outcome>Activities of Daily Living. Timepoint: Pretest, post test and follow-up. Method of measurement: Functional Independence Measure (FIM).</sec_outcome>
      <sec_outcome>Fatigue. Timepoint: Pretest, post test and follow-up. Method of measurement: Parkinson Fatigue Scale (PFS).</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>2020-02-12</approval_date>
        <contact_name>Ethics committee of Tehran university of medical sciences</contact_name>
        <contact_address>Tehran university of medical sciences, school of rehabilitation, Enghelab St, Pich-e-Shemiran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
