<?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>IRCT20160808029260N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-05-13</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the impact of occupational therapy based on daily life activities on the performance and satisfaction level of stroke patients</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Occupational Therapy Intervention Process Model (OTIPM) on occupational performance and satisfaction of patients with chronic stroke and comparing it with conventional occupational therapy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69941</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using a table of random numbers by a person who has no contact with the patients, the patients are placed in two groups in the form of random blocks, the patients in the first group received conventional occupational therapy treatments and in the second group received occupational therapy based on the OTIPM model (the main intervention), Blinding description: The present study is single blind (evaluator).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Stroke.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention of the second occupational therapy group is based on the OTIPM model (main intervention). In this group, once the client has prioritized which activities of daily living should be addressed, the occupational therapist, after observing the challenging activities of daily living of the person in the natural context of the client, analyzes the ineffective skills and tasks in performing the performance of each prioritized task (occupation). And it takes into account person effective factors, including body function, task needs, or the influence of the environment in the implementation of occupation. After completing the performance analysis, the occupational therapist and the clients work together to create client-centered and occupation-centered goals, and there are four choices in the intervention stage: compensatory, educational, acquisition, and restoration (steps of implementing this intervention in the attached file) The full length has been described (23, 33). This group of interventions with the presence of an occupational therapist at home and three sessions a week, for ten weeks and each session is one hour, These interventions are implemented by the researcher who has trained the model implementation courses. Intervention 2: Control group: The intervention of the first group includes conventional occupational therapy interventions. These interventions included neurodevelopmental treatment, Bobath technique, facilitation of neuromuscular proprioception, pain management, hand manipulation skills and dexterity training were provided to the participants. These interventions are performed in the outpatient occupational therapy center in three sessions per week, for ten weeks and each session is one hour, These interventions are implemented by an occupational therapist who has at least 2 years of practical experience.</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:
Demographic data of the study participants after making them unidentifiable; Primary and secondary outcome information

When:
After publishing the results of the study

To whom:
Researchers who are working in academic and scientific institutions

Conditions:
For doing meta-analysis review studies

Where to obtain:
Esmail sadeghi Phone number:00989120302534 Email address: sadeghi.ot87@gmail.com Address: School of Rehabilitation, Madadkaran Alley, Shahnazari Street, Madar Square, Mirdamad Boulevard, Tehran, Iran 2) Afsoon Hassani Mehraban Phone number: 0098 21 22228051 Email address: mehraban.a@iums.ac.ir Address: School of Rehabilitation, Madadkaran Alley, Shahnazari Street, Madar Square, Mirdamad Boulevard, Tehran, Iran

How to obtain:
The researcher can access the data of this research up to one month after sending the request and attaching the registered protocol of the review article to the introduced emails.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Afsoon hassani mehraban</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mirdamad</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>13487-15459</zip>
        <telephone>+98 21 2222 7124</telephone>
        <email>Mehraban.a@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Esmail Sadeghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mirdamad</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>13487-15459</zip>
        <telephone>+98 21 2222 7124</telephone>
        <email>sadeghi.ot87@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Occurrence of a stroke
Age 18 to 65 years
Branstrom above 3
MMSE above 21
Living at home
At least 6 months have passed since the stroke
The doctor has referred the person to receive occupational therapy services</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>People have acute heart diseases (such as acute heart attack)
People have serious psychological diseases (such as depression and psychiatric disorders)
People have neurological diseases (such as recurrent stroke, Parkinson's, dementia, seizures)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I67</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other cerebrovascular diseases</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 of the second occupational therapy group is based on the OTIPM model (main intervention). In this group, once the client has prioritized which activities of daily living should be addressed, the occupational therapist, after observing the challenging activities of daily living of the person in the natural context of the client, analyzes the ineffective skills and tasks in performing the performance of each prioritized task (occupation). And it takes into account person effective factors, including body function, task needs, or the influence of the environment in the implementation of occupation. After completing the performance analysis, the occupational therapist and the clients work together to create client-centered and occupation-centered goals, and there are four choices in the intervention stage: compensatory, educational, acquisition, and restoration (steps of implementing this intervention in the attached file) The full length has been described (23, 33). This group of interventions with the presence of an occupational therapist at home and three sessions a week, for ten weeks and each session is one hour, These interventions are implemented by the researcher who has trained the model implementation courses.</i_keyword>
      <i_keyword>Control group: The intervention of the first group includes conventional occupational therapy interventions. These interventions included neurodevelopmental treatment, Bobath technique, facilitation of neuromuscular proprioception, pain management, hand manipulation skills and dexterity training were provided to the participants. These interventions are performed in the outpatient occupational therapy center in three sessions per week, for ten weeks and each session is one hour, These interventions are implemented by an occupational therapist who has at least 2 years of practical experience.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Occupational performance (a dynamic interaction involving the person, context/environment, and activity or occupation) is the focus of occupational therapy practice. including skills (purposeful actions to perform occupations such as motor skills, processing skills, social interaction skills), patterns (temporal elements of occupation such as routines, habits, roles, rituals) and domains (work/productivity, play/leisure (such as play), sports, hobbies) are the basic and functional activities of daily living such as rest/sleep). Timepoint: Before the intervention, after 10 weeks of intervention, the first and third month after the end of the intervention. Method of measurement: Occupational performance is measured with the help of COPM and ADL taxonomy scores.</prim_outcome>
      <prim_outcome>Satisfaction: the degree of satisfaction of people with occupational performance and the match between occupational participation and performance expectations. Timepoint: Before the intervention, after 10 weeks of intervention, the first and third month after the end of the intervention. Method of measurement: The score of the COPM questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Functional performance: Physiological functions of body systems. Timepoint: Before the intervention, after 10 weeks of intervention, the first and third month after the end of the intervention. Method of measurement: In this study, body functions are measured with the help of ARAT, FMA and SIS questionnaire scores.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-05-01</approval_date>
        <contact_name>Research Ethics Committees of Iran University of Medical Sciences</contact_name>
        <contact_address>Iran University of Medical Sciences, Next to Milad tower, Hemmat Highway Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
