<?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>IRCT20120910010806N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-02-14</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of “Cognitive Orientation to daily Occupational Performance (CO-OP)” on motivation and participation of 8-12 years old children with cerebral palsy</public_title>
      <acronym></acronym>
      <scientific_title>The comparison of “Cognitive Orientation to daily Occupational Performance (CO-OP)” with Current Treatment Approach (CTA) on motivation and participation of 8-12 years old children with cerebral palsy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-02-12</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>9</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/29362</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Cognitive Orientation to Daily Occupational Performance (CO-OP): is a well-explicated top-down, problem solving approach that has been shown to support skill acquisition and a client-centered approach. The CO-OP approach differ from traditional bottom-up interventions in that it is situated in a learning paradigm and use cognitive strategies to facilitate skill acquisition at the ICF activity rather than structure and function level, and draw on motor learning principle to help children discover how to perform everyday activities. The main objective  of CO-OP are skill acquisition, the learning of global problem solving strategy (goal, plan, do, check) and the identification of domain-specific strategies to support generalization to the other environment and transfer to other motor-based tasks. CO-OP can be used to enable the achievement of occupation-based goal while simultaneously promoting self-efficacy. “9 child with inclusion criteria will enter to CO-OP  group., Each sample will receive the intervention two days a week and 2 hours in every day. Each sample will receive 12 hours treatment. Current Treatment Approach(CTA) for children with cerebral palsy: this treatment typically focus on remediation or bottom-up approaches. Many of this therapeutic approaches to managing cerebral palsy are based on neuromaturational models of motor development which focus on improving motor movement (bottom-up approaches) and do not emphasize performance in every day activities. Other approaches implementing these bottom-up strategies, such as casting and positioning techniques, can be effective in achieving in anatomical goals such as increase range of motion and enhancing postural tone. Little evidence exists that achieving these anatomical goals translates into improved task performance or motor-based skill acquisition among children with cp, Randomization description: Participants will select by covenience sampling. Randomizing participants in CO-OP &amp; CTA groups will done with randomization digits table by a blind person to the study, Blinding description: Participants will not aware of the group that are randomized. In this study the assesments will performed by parent, the child and trained assessor who are blind to the study. The data will enter in SPSS and statistically analysis by a blind statistician.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Cerebral Palsy (CP).</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Cognitive orientation to daily occupational performance (CO-OP): is a well-explicated top-down, problem solving approach that has been shown to support skill acquisition and a client-centered approach. The CO-OP approach differ from traditional bottom-up interventions in that it is situated in a learning paradigm and use cognitive strategies to facilitate skill acquisition at the ICF activity rather than structure and function level, and draw on motor learning principle to help children discover how to perform everyday activities. The main objective  of CO-OP are skill acquisition, the learning of global problem solving strategy (goal, plan, do, check) and the identification of domain-specific strategies to support generalization to the other environment and transfer to other motor-based tasks. CO-OP can be used to enable the achievement of occupation-based goal while simultaneously promoting self-efficacy. in this study participant will choose three treatment goals by use of Candian Occupational Performance Model (COPM). Primary sessions of CO-OP include to review the child's  "daily activity log", setting goals and teaching general strategies. Middle sessions include facilitating the learning and use of domain specific strategy and family education . In the final sessions, the suppportive role of therapist  is reduced and the child is prepared for the transfer of general and specific strategies to other tasks. Intervention 2: Control group: Current treatment approach (CTA)Current approach for children with cerebral palsy: this treatment typically focus on remediation or bottom-up approaches. Many of this therapeutic approaches to managing cerebral palsy are based on neuromaturational models of motor development which focus on improving motor movement (bottom-up approaches) and do not emphasize performance in every day activities. Other approaches implementing these bottom-up strategies, such as casting and positioning techniques, can be effective in achieving in anatomical goals such as increase range of motion and enhancing postural tone. Little evidence exists that achieving these anatomical goals translates into improved task performance or motor-based skill acquisition among children with cp. 9 children between age 8-12 will receive twelve 45-minute sessions of intervention on average twice per week.</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 puplished

When:
March 2019

To whom:
The researcher and occupational therapists

Conditions:
Other research, critics, check and clinical usage

Where to obtain:
First person in article

How to obtain:
Send request by email

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Poorzamani Dehkordi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Occupational Therapy department- School of Rehabilitation Sciences- Madadkaran alley- Shah-Nazari street- Madar square- Mirdamad avenue</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1545913487</zip>
        <telephone>+98 21 2222 2059</telephone>
        <email>poorzamani_zp@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Malahat Akbarfahimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Occupational Therapy department- School of Rehabilitation Sciences- Madadkaran alley- Shah-Nazari street- Madar square- Mirdamad avenue</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1545913478</zip>
        <telephone>+98 21 2222 2059</telephone>
        <email>akbarfahimi.m@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 8 and 12 years at the time of sampling
Diagnosis of cerebral palsy that is determined by a neurologist
Level 1, 2, or 3 on the Gross Motor Function Classification Scale (GMFCS)
Level 1,2 or 3 on The Manual Ability Classification System (MACS)
Normal intelligence
Normal or near to normal in hearing and vision
Sufficient language ability to communicate with the therapist and be understood during treatment</inclusion_criteria>
      <agemin>8 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Dissuasion of parents in making response to questions of measurements or bringing students to the intervention sessions
Dissuasion of students in making response to questions of measurements or coming to the intervention sessions
Child had previously received, or is presently receiving, a cognitive treatment</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G80</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Cerebral palsy</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: Cognitive orientation to daily occupational performance (CO-OP): is a well-explicated top-down, problem solving approach that has been shown to support skill acquisition and a client-centered approach. The CO-OP approach differ from traditional bottom-up interventions in that it is situated in a learning paradigm and use cognitive strategies to facilitate skill acquisition at the ICF activity rather than structure and function level, and draw on motor learning principle to help children discover how to perform everyday activities. The main objective  of CO-OP are skill acquisition, the learning of global problem solving strategy (goal, plan, do, check) and the identification of domain-specific strategies to support generalization to the other environment and transfer to other motor-based tasks. CO-OP can be used to enable the achievement of occupation-based goal while simultaneously promoting self-efficacy. in this study participant will choose three treatment goals by use of Candian Occupational Performance Model (COPM). Primary sessions of CO-OP include to review the child's  "daily activity log", setting goals and teaching general strategies. Middle sessions include facilitating the learning and use of domain specific strategy and family education . In the final sessions, the suppportive role of therapist  is reduced and the child is prepared for the transfer of general and specific strategies to other tasks.</i_keyword>
      <i_keyword>Control group: Current treatment approach (CTA)Current approach for children with cerebral palsy: this treatment typically focus on remediation or bottom-up approaches. Many of this therapeutic approaches to managing cerebral palsy are based on neuromaturational models of motor development which focus on improving motor movement (bottom-up approaches) and do not emphasize performance in every day activities. Other approaches implementing these bottom-up strategies, such as casting and positioning techniques, can be effective in achieving in anatomical goals such as increase range of motion and enhancing postural tone. Little evidence exists that achieving these anatomical goals translates into improved task performance or motor-based skill acquisition among children with cp. 9 children between age 8-12 will receive twelve 45-minute sessions of intervention on average twice per week.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Participation. Timepoint: pretest , post test and follow-up (two months after last session). Method of measurement: Life habit questionnaire(LIFE_H) for 5-13 years children with cerebral palsy.</prim_outcome>
      <prim_outcome>Motivation during therapy. Timepoint: sessions 1, 3,7,11 and 12. Method of measurement: The Pediatric motivation scale for children rehabilitation.</prim_outcome>
      <prim_outcome>Mastery motivation. Timepoint: pretest , post test and follow-up (two months after last session). Method of measurement: Dimensions of mastery questionnaire (DMQ) The DMQ parent proxy-report.</prim_outcome>
      <prim_outcome>Volition. Timepoint: pretest , post test and follow-up (two months after last session). Method of measurement: Pediatric volitional questionnaire (PVQ).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Goal achievement. Timepoint: Pretest, post test and follow-up. Method of measurement: Goal Attainment scale (GAS).</sec_outcome>
      <sec_outcome>Performance and satisfaction scores of child-chosen goal. Timepoint: Pretest, post test and follow-up. Method of measurement: Canadian Occupational Performance Measurement (COPM).</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>2018-01-18</approval_date>
        <contact_name>کمیته اخلاق دانشگاه علوم پزشکی و خدمات درمانی ایران</contact_name>
        <contact_address>iran univercity of medical science- shahid Hemmat highway- Tehran- Iran tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
