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2 2021-02-24, 1399/12/06 172500
1 2018-02-14, 1396/11/25 37028
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  • Protocol summary

    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
    The comparison of (CO-OP)” with current treatment approach (CTA) on motivation and participation
    مقایسه رویکرد شناخت گرا به عملکرد کاری روزمره (CO_OP) با درمان های رایج کاردرمانی (CTA) بر انگیزه و مشارکت کودکان فلج مغزی 12-8 سال با هوش عادی
    مقایسه مداخله شناخت گرا CO-OP با درمان های رایج کاردرمانی بر انگیزه و مشارکت
    After approval of the proposal, the ethical code is drawn up. Iran univercity of medical science introduce the researcher to exceptional education organization for recieving license to enter to schools. We will communicate with the families and invite them to examine the child condition and inclusion criteria by Gross motor function classification system (GMFCS), The Manual Ability Classification System (MACS) and colored Raven intelligence scale. we randomize children to groups of A & B (A: CO-OP and B: CTA). people in group A, will choose three intervention goal with parent and child by using Candian Occupational Performance Model (COPM) and will receive twelve 45-minute sessions of intervention on average twice per week. In group B, children recieve 12 sessions of traditional treatment of occupational therapy. To assess volition, we will use "pediatric volitional questionnaire 2.1" that is an observational questionnaire, will fill by a blinded assessor in Pre and post treatment & session 6. This assessor will observe child behavior in the film recorded. The "Pediatric motivation" (PMOT) scale, assesses motivation from children perspective during therapy session. The questionnaire will be filled by the child in sessions 1, 3,7,11 and 12. "Dimensions of mastery questionnaire(DMQ) parent proxy-report" and "Life habit questionnaire" (LIFE_H) for 5-13-years children with cerebral palsy to assess participation will fill at pre and post session by parents.
    consent form will obtain from parents. children who eligible are randomly assigned to CO-OP and CTA groups. partcipant choose their three treatment goals based on COPM. pediatric volitional questionnaire in children are administered by an unaware therapist through video recording pre/post-test and follow-up. On thePediatric motivation" (PMOT) is completed by the child in sessions 1, 3, 7, 12 during intervention. "Dimensions of mastery questionnaire(DMQ), "Life habit questionnaire" (LIFE_H) GAS and COPM will be filled in pre/post test and follow-up. " ,
    پس از تصویب پروپوزال طرح و گرفتن کد اخلاق، دریافت نامه از دانشگاه برای مراکز کادرمانی دانشگاه علوم پزشکی ایران و اداره آموزش و پرورش کل استثنایی انجام می شود. سپس اداره آموزش و پرورش کل نامه معرفی به مدارس را ارائه می¬دهد. سپس با خانواده ها ارتباط برقرار میکنیم و جهت بررسی شرایط کودک و بررسی معیار های ورود از آنها دعوت بعمل می¬آید. کودکان برای ورود به مطالعه ابتدا توسط سیستم طبقه بندی کارکرد حرکتی درشت و سیستم طبقه بندی توانایی دستی و مقیاس هوشی ریون رنگی مورد بررسی قرار می¬گیرند. و پس از آن کودکانی که معیار های ورود را داشته باشند پس از تکمیل فرم رضایت از ورود به مداخله، به هر کودک یک کد اختصاص می دهیم و سپس تخصیص تصادفی کودکان را به دو گروه الف و ب انجام می¬دهیم (گروه الف:CO-OP و گروه ب: CTA ). در طی مطالعه افرادی که وارد گروه الف مطالعه می شوند، ابتدا توسط COPM 3 هدف درمان توسط والدین و کودک انتخاب می شود. سپس کودک تحت 12 جلسه درمان هفتگی شناختی بالا به پایین به مدت 45 تا 60 دقیقه، به مدت 2 ماه قرار می گیرند. جلسات به صورت 2 جلسه در هفته برگزار خواهد شد. در گروه مداخلات ب ، افراد تحت 12 جلسه درمان های پایین به بالا قرار می گیرند. سپس انگیزش آنها توسط پرسشنامه های انگیزه ی انجام کار در کودکان نسخه 2.1 یک پرسشنامه مشاهده ای است. معیار های پرسشنامه توسط درمانگری که در انجام مداخله دخیل نیست، در ابتدا، میانه و انتهای درمان با مشاهده رفتار کودک در فیلم ضبط شده، تکمیل می¬شود. مقیاس انگیزه کودکان توسط خود کودک در چهار مرحله ارزیابی، آمورزش، اکتساب و تثبیت (جلسات قبل درمان،1،3،7،11 و بعد درمان ) انگیزه در حین فعالیت کودکان مورد سنجش واقع می¬شود. پرسشنامه انگیزه ی کودکان دبستانی ، در ابتدا و انتهای درمان مورد سنجش قرار خواهد گرفت، به منظور بررسی بیشتر در میانه جلسات درمان نیز ارزیابی مجدد انجام می گیرد. میزان مشارکت کودکان فلج مغزی با استفاده از پرسشنامه سنجش عادات زندگی نیز قبل و بعد از مداخله توسط والدین کودکان تکمیل می¬گردد. به منظور بررسی های بیشتر از تعدادی از جلسات فیلم تهیه می¬گردد.و همچنین به منظور کورسازی جمع کردن نمرات پرسشنامه و وارد کردن در نرم افزارSpss توسط فردی که نسبت به گروه های مداخله آگاه نیست، انجام می¬شود.
    پس از کسب مجوز و رضایت از والدین، کودکان جهت شرکت در مطالعه، کودکانی که معیارهای ورود را دارندبه دو گروه CO-OP وCTA تخصیص تصادفی داده می‌شوند. دو گروه سه هدف درمانی شان را براساس COPM انتخاب می کنند. پرسشنامه های انگیزه ی انجام کار در کودکان توسط درمانگر نااگاه از طریق ویدیو ظبط شده در پیش/پس درمان و دوره پیگیری انجام می‌شود. در مقیاس انگیزه کودکان) انگیزه در حین فعالیت کودکان توسط خود کودک در جلسات 1،3،7،12 تکمیل می‌شود. پرسشنامه انگیزه ی کودکان دبستانی، پرسشنامه سنجش عادات زندگی، GAS و COPM در ابتدا ، انتهای و دوره پیگیری درمان مورد سنجش قرار خواهد گرفت.به منظور بررسی های بیشتر از تعدادی از جلسات فیلم تهیه می‌گردد.
    Inclusion criteria: age 8 and 12 years of age at the time of intake; diagnosis of cerebral palsy that is determined by 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 that is determined by Raven test; normal or corrected to normal, hearing and vision; sufficient language ability to communicate with and beunderstood during treatment. 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 were presently receiving, a cognitive treatment.
    Inclusion criteria: age 8 and 12 years of age a; diagnosis of cerebral palsy that is determined by neurologist; level 1- 3 on the Gross Motor Function Classification Scale (GMFCS); level 1- 3 on The Manual Ability Classification System (MACS); normal intelligence that is determined by Raven test; normal or corrected to normal hearing and vision; sufficient language ability Exclusion criteria: dissuasion of parents and child ; child had previously received a cognitive treatment.
    سن 8 تا 12 سال در زمان ورود به مطالعه تشخیص اختلال فلج مغزی توسط پزشک نورولوژیست کودکان در سطح 3-1 مقیاس GMFCS کودکان در سطح 3-1 مقیاس MACS هوش نرمال که با انجام تست ریون مشخص می شود حس بینایی و شنوایی نرمال یا نزدیک به نرمال (یا با استفاده از عینک و سمعک به حد نرمال برسد). توانایی کلامی کافی برای ارتباط با درمانگر مشارکت و فهمیدن در طول درمان شرایط عمده عدم ورود به مطالعه قبل از تصادفی سازی - عدم رضایت خانواده در پاسخ به سوالات و ارزیابی ها و یا آوردن کودک به جلسات درمان - عدم تمایل کودک برای پاسخ به سوالات و یا آمدن به جلسه درمان - دریافت درمان های شناختی در حال و گذشته
    سن 8 تا 12 سال ، تشخیص فلج مغزی توسط نورولوژیست، سطح 3-1 مقیاس GMFCS ، سطح 3-1 مقیاس MACS، هوش نرمال براساس تست ریون ، حس بینایی و شنوایی نرمال یا نزدیک به نرمال (یا با استفاده از عینک و سمعک به حد نرمال برسد)، ارتباط کلامی کافی شرایط عمده عدم ورود - عدم رضایت خانواده - عدم تمایل کودک - دریافت درمان های شناختی در گذشته
    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 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.
    CO-OP group: Children choose three goals based on COPM and with the approach of CO-OP", acquire skills, learn general problem-solving strategies (goal, planning, implementation, review and identification of strategies specific to the CO-OP). This study will be presented in 45 to 1 hour sessions twice a week for 12. CTA : 45- to 1-hour sessions will be offered twice a week for 12 sessions.
    در گروه مداخله CO-OP : مداخلات "شناخت گرا بر عملکرد کاری روزمره CO-OP))" یک رویکرد حل مسأله، بالا به پایین است که برای حمایت از اکتساب مهارت ها و رویکرد های مراجع محور طراحی شده است. این رویکرد از رویکرد های سنتی پایین به بالا متفاوت است، زیرا این رویکرد به یادگیری و استفاده از راهبردهای شناختی برای تسهیل اکتساب مهارت ها تأکید دارد. این رویکرد از اصول از یادگیری حرکتی برای کمک به کودکان برای کشف چگونگی انجام فعالیت های روزمره گرفته شده است. هدف اصلی CO-OP اکتساب مهارت ها، یادگیری راهبرد های کلی حل مسأله (هدف، برنامه ریزی، انجام، بررسی و شناسایی راهبرد های حوزه خاص در اهدافی است که توسط خود کودک انتخاب می شود. CO-OP در این مطالعه به صورت جلسات 45 تا 1ساعته به صورت دو بار در هفته به مدت 12 جلسه ارائه خواهد شد. مداخلات رایج کاردرمانی (CTA): بر اساس مدلهای رشد عصبی برای رشد حرکت هستند، که در این درمان ها فرض بر آن است که بهبود پیش نیاز مهارت ها برای رشد عملکرد فعالیت ها ضروری است. این رویکرد های پایین به بالا به بهبود نقص های اساسی و توسعه رشد عصبی تاکید دارد. این درمان ها مبتنی بر اجزا مانند بوبت، یکپارچگی حسی و ... هستند که منجر به اکتساب اهداف بیومکانیکی می شوند. شواهد اندکی وجود دارد که نشان دهد اکتساب اهداف بیوکانیکی منجر به بهبود عملکرد حرکتی وظایف یا اکتساب مهارت های حرکتی در بین کودکان فلج مغزی می شود.
    در گروه مداخله CO-OP : کودکان سه هدف را براساس COPM انتخاب می‌کنند و از راهبرد های کلی حل مسأله (هدف، برنامه ریزی، انجام، بررسی)جهت دستیابی به اهداف استفاده می‌کنند این مطالعه به صورت جلسات 45 تا 1ساعته به صورت دو بار در هفته به مدت 12 جلسه ارائه خواهد شد. مداخلات رایج کاردرمانی (CTA): جلسات 45 تا 1ساعته به صورت دو بار در هفته به مدت 12 جلسه ارائه خواهد شد.
    Participation; Mastery motivation; Volition; Motivation during therapy
    Primary outcomes: Participation, motivation during rehabilitation,Mastery motivation to master, Volition Secondary Outcomes: Satisfaction and Performance Score of COPM, Goal Attainment Scale(GAS)
    مشارکت؛ انگیزه تسلط؛ اراده؛ انگیزه در طول توانبخشی
    پیامدهای اولیه: مشارکت ، انگیزه در طول توانبخشی، انگیزه تسلط، اراده پیامدهای ثانویه: نمره رضایت و عملکرد، دستیابی به اهداف
  • General information

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    2020-01-20, 1398/10/30
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    2020-01-30, 1398/11/10
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    The results of the pilot study showed that the evaluation of the second stage (sixth session) is indeterminate due to interfere with intervention programs for performing second activity goals (we had three goals, each goal approximately required 4 sessions of intervention, the sixth session is one of the goals in the middle of which the results could not be analyzed) Therefore, the evaluation of the second stage was removed and replaced with a follow-up evaluation two months after the last session. In order to assess the achievement of children's goals in the study, with a top-down approach and a client-centered approach, the Assessment of Goal Attainment Scale (GAS) and the Canadian occupational Performance Measurement(COPM) were included to the study as secondary outcomes. The main reasons for not updating on time are: 1- Training of the therapist "Cognitive to daily work performance (CO_OP)" which lasted about four months, 2- The need to run a pilot, the results of which lasted six months, 3- Consequences of the Covid 19 pandemic.4: Edit and summerize the abstract due to word count limitation
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    نتایج مطالعه مقدماتی نشان داد که ارزیابی مرحله دوم (جلسه ششم) بدلیل تداخل با برنامه ها مفید نمی باشد( ما سه هدف داشتیم، هر هدف 4 جلسه مداخله نیاز داشت، جلسه ششم در میانه یکی از اهداف است که نتایج ان قابل انالیز نبود)، لذا ارزیابی مرحله دوم حذف گردید و بجای آن ارزیابی پیگیری دو ماه پس از آخرین جلسه جایگزین گردید. بهمنظور بررسی میزان دستیابیبه اهداف کودکان در مطالعه، با رویکرد بالا به پایین و نگاه مراجع - مدار، ارزیابی مقیاس دستیابی به هدف (GAS)و مقیاس کانادایی عملکرد کاری(COPM) بعنوان پیامدهای ثانویه به مطالعه افزوده شد. اهم دلایل عدم بروزرسانی بموقع عبارتند از: 1- آموزش درمانگر " شناخت گرا به عملکرد کاری روزمره (CO_OP)" که حدودا 6 ماه به طول انجامید، 2- ضرورت اجرای پایلوت، که نتایج ان سه ماه طول کشید، 3- تبعات ناشی ازهمه گیری کووید 19 4 ویرایش چکیده بمنظور خلاصه سازی
  • Health conditions studied

    #1
    G80-G83
    G80
    Cerebral palsy and other paralytic syndromes
    Cerebral palsy
  • Primary outcomes

    #1
    pre and post treatment
    pretest , post test and follow-up (two months after last session)
    قبل و بعد درمان
    قبل از شروع، بعد از اتمام مداخله و پیگیری 2 ماه پس از اتمام مداخله
    #2
    در جلسات 12, 1،3،7،11 سنجیده می شود.
    در جلسات 12, 1،3،7،11
    #3
    Pre and post treatment + session 6
    pretest , post test and follow-up (two months after last session)
    قبل از شروع، میانه و بعد از اتمام مداخله
    قبل از شروع، بعد از اتمام مداخل و پیگیری 2 ماه پس از اتمام مداخله
    Dimensions of mastery questionnaire (DMQ) The DMQparent proxy-report
    Dimensions of mastery questionnaire (DMQ) The DMQ parent proxy-report
    #4
    انگیزه در حین فعالیت
    اراده
    Pre and post treatment + session 6
    pretest , post test and follow-up (two months after last session)
    قبل از شروع، میانه جلسات و پس از اتمام مداخله
    قبل از شروع، بعد از اتمام مداخله و پیگیری 2 ماه پس از اتمام مداخله
  • Secondary outcomes

    #1
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    Goal achievement
    empty
    دستيابي به اهداف
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    Pretest, post test and follow-up
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    قبل /بعد مداخله و دوره پيگيري
    empty
    Goal Attainment scale (GAS)
    empty
    مقياس دستيابي به اهداف (GAS)
    #2
    empty
    Performance and satisfaction scores of child-chosen goal
    empty
    عملکرد و رضايت در اهداف انتخابی
    empty
    Pretest, post test and follow-up
    empty
    قبل /بعد مداخله و دوره پيگيري
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    Canadian Occupational Performance Measurement (COPM)
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    مقياس کانادايي عملکرد کاري (COPM)
  • Person responsible for general inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: zahra poorzamani dehkordi
    Full name of responsible person - Persian: زهرا پورزمانی دهکردی
    Position - English: master candidate of Occupational Therapy
    Position - Persian: دانشجوی کارشناسی ارشد
    Latest degree: bachelor
    Area of specialty/work: 72
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Occupational Therapy department- School of Rehabilitation Sciences- Madadkaran alley- Shah-Nazari street- Madar square- Mirdamad avenue
    Street address - Persian: خیابان میرداماد- میدان مادر- خیابان شاه نظری- کوچه مددکاران- دانشکده توانبخشی- گروه کاردرمانی
    City - English: tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1545913487
    Phone: +98 21 2222 2059
    Mobile: +98 913 880 6955
    Fax:
    Email: poorzamani_zp@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Zahra Poorzamani Dehkordi
    Full name of responsible person - Persian: زهرا پورزمانی دهکردی
    Position - English: master candidate of Occupational Therapy
    Position - Persian: دانشجوی کارشناسی ارشد
    Latest degree: bachelor
    Area of specialty/work: 72
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Occupational Therapy department- School of Rehabilitation Sciences- Madadkaran alley- Shah-Nazari street- Madar square- Mirdamad avenue
    Street address - Persian: خیابان میرداماد- میدان مادر- خیابان شاه نظری- کوچه مددکاران- دانشکده توانبخشی- گروه کاردرمانی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1545913487
    Phone: +98 21 2222 2059
    Mobile: +98 913 880 6955
    Fax:
    Email: poorzamani_zp@yahoo.com
    Web page address:
  • Person responsible for scientific inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: dr malahat akbarfahimi
    Full name of responsible person - Persian: دکتر ملاحت اکبر فهیمی
    Position - English: PhD in neuroscience- Faculty of Iran Univercity of Medical Sciences
    Position - Persian: دکتری تخصصی علوم اعصاب شناختی- عضو هیئت علمی دانشگاه علوم پزشکی ایران
    Latest degree: phd
    Area of specialty/work: 63
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Occupational Therapy department- School of Rehabilitation Sciences- Madadkaran alley- Shah-Nazari street- Madar square- Mirdamad avenue
    Street address - Persian: خیابان میرداماد- میدان مادر- خیابان شاه نظری- کوچه مددکاران- دانشکده توانبخشی- گروه کاردرمانی
    City - English: tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1545913478
    Phone: +98 21 2222 2059
    Mobile: +98 912 336 2925
    Fax:
    Email: akbarfahimi.m@iums.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr Malahat Akbarfahimi
    Full name of responsible person - Persian: دکتر ملاحت اکبرفهیمی
    Position - English: PhD in neuroscience- Faculty of Iran Univercity of Medical Sciences
    Position - Persian: دکتری تخصصی علوم اعصاب شناختی- عضو هیئت علمی دانشگاه علوم پزشکی ایران
    Latest degree: phd
    Area of specialty/work: 63
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Occupational Therapy department- School of Rehabilitation Sciences- Madadkaran alley- Shah-Nazari street- Madar square- Mirdamad avenue
    Street address - Persian: خیابان میرداماد- میدان مادر- خیابان شاه نظری- کوچه مددکاران- دانشکده توانبخشی- گروه کاردرمانی
    City - English: tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1545913478
    Phone: +98 21 2222 2059
    Mobile: +98 912 336 2925
    Fax:
    Email: akbarfahimi.m@iums.ac.ir
    Web page address:
  • Person responsible for updating data


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: zahra poorzamani dehkordi
    Full name of responsible person - Persian: زهرا پورزمانی دهکردی
    Position - English: master candidate of Occupational Therapy
    Position - Persian: دانشجوی کارشناسی ارشد کاردرمانی
    Latest degree: bachelor
    Area of specialty/work: 72
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Occupational Therapy department- School of Rehabilitation Sciences- Madadkaran alley- Shah-Nazari street- Madar square- Mirdamad avenue
    Street address - Persian: خیابان میرداماد- میدان مادر- خیابان شاه نظری- کوچه مددکاران- دانشکده توانبخشی- گروه کاردرمانی
    City - English: tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1545913487
    Phone: +98 21 2222 7124
    Mobile: +98 913 880 6955
    Fax:
    Email: poorzamani_zp@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Zahra Poorzamani Dehkordi
    Full name of responsible person - Persian: زهرا پورزمانی دهکردی
    Position - English: master candidate of Occupational Therapy
    Position - Persian: دانشجوی کارشناسی ارشد کاردرمانی
    Latest degree: bachelor
    Area of specialty/work: 72
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Occupational Therapy department- School of Rehabilitation Sciences- Madadkaran alley- Shah-Nazari street- Madar square- Mirdamad avenue
    Street address - Persian: خیابان میرداماد- میدان مادر- خیابان شاه نظری- کوچه مددکاران- دانشکده توانبخشی- گروه کاردرمانی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1545913487
    Phone: +98 21 2222 7124
    Mobile: +98 913 880 6955
    Fax:
    Email: poorzamani_zp@yahoo.com
    Web page address:

Protocol summary

Study aim
The comparison of (CO-OP)” with current treatment approach (CTA) on motivation and participation
Design
Clinical, Randomized, Tripple-blind trial with two parallel group
Settings and conduct
consent form will obtain from parents. children who eligible are randomly assigned to CO-OP and CTA groups. partcipant choose their three treatment goals based on COPM. pediatric volitional questionnaire in children are administered by an unaware therapist through video recording pre/post-test and follow-up. On thePediatric motivation" (PMOT) is completed by the child in sessions 1, 3, 7, 12 during intervention. "Dimensions of mastery questionnaire(DMQ), "Life habit questionnaire" (LIFE_H) GAS and COPM will be filled in pre/post test and follow-up. " ,
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 8 and 12 years of age a; diagnosis of cerebral palsy that is determined by neurologist; level 1- 3 on the Gross Motor Function Classification Scale (GMFCS); level 1- 3 on The Manual Ability Classification System (MACS); normal intelligence that is determined by Raven test; normal or corrected to normal hearing and vision; sufficient language ability Exclusion criteria: dissuasion of parents and child ; child had previously received a cognitive treatment.
Intervention groups
CO-OP group: Children choose three goals based on COPM and with the approach of CO-OP", acquire skills, learn general problem-solving strategies (goal, planning, implementation, review and identification of strategies specific to the CO-OP). This study will be presented in 45 to 1 hour sessions twice a week for 12. CTA : 45- to 1-hour sessions will be offered twice a week for 12 sessions.
Main outcome variables
Primary outcomes: Participation, motivation during rehabilitation,Mastery motivation to master, Volition Secondary Outcomes: Satisfaction and Performance Score of COPM, Goal Attainment Scale(GAS)

General information

Reason for update
The results of the pilot study showed that the evaluation of the second stage (sixth session) is indeterminate due to interfere with intervention programs for performing second activity goals (we had three goals, each goal approximately required 4 sessions of intervention, the sixth session is one of the goals in the middle of which the results could not be analyzed) Therefore, the evaluation of the second stage was removed and replaced with a follow-up evaluation two months after the last session. In order to assess the achievement of children's goals in the study, with a top-down approach and a client-centered approach, the Assessment of Goal Attainment Scale (GAS) and the Canadian occupational Performance Measurement(COPM) were included to the study as secondary outcomes. The main reasons for not updating on time are: 1- Training of the therapist "Cognitive to daily work performance (CO_OP)" which lasted about four months, 2- The need to run a pilot, the results of which lasted six months, 3- Consequences of the Covid 19 pandemic.4: Edit and summerize the abstract due to word count limitation
Acronym
IRCT registration information
IRCT registration number: IRCT20120910010806N5
Registration date: 2018-02-14, 1396/11/25
Registration timing: prospective

Last update: 2021-02-24, 1399/12/06
Update count: 1
Registration date
2018-02-14, 1396/11/25
Registrant information
Name
Malahat Akbarfahimi
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 7124
Email address
akbarfahimi.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-12, 1396/11/23
Expected recruitment end date
2018-06-21, 1397/03/31
Actual recruitment start date
2018-12-22, 1397/10/01
Actual recruitment end date
2020-01-20, 1398/10/30
Trial completion date
2020-01-30, 1398/11/10
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
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
Purpose
Treatment
Inclusion/Exclusion 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
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
Age
From 8 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 9
Actual sample size reached: 9
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will select by covenience sampling. Randomizing participants in CO-OP & CTA groups will done with randomization digits table by a blind person to the study.
Blinding (investigator's opinion)
Triple blinded
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.
Placebo
Not used
Assignment
Parallel
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.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
کمیته اخلاق دانشگاه علوم پزشکی و خدمات درمانی ایران
Street address
iran univercity of medical science- shahid Hemmat highway- Tehran- Iran
City
tehran
Province
Tehran
Postal code
1449614535
Approval date
2018-01-18, 1396/10/28
Ethics committee reference number
IR.IUMS.REC1396.9511355001

Health conditions studied

1

Description of health condition studied
Cerebral Palsy (CP)
ICD-10 code
G80
ICD-10 code description
Cerebral palsy

Primary outcomes

1

Description
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

2

Description
Motivation during therapy
Timepoint
sessions 1, 3,7,11 and 12
Method of measurement
The Pediatric motivation scale for children rehabilitation

3

Description
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

4

Description
Volition
Timepoint
pretest , post test and follow-up (two months after last session)
Method of measurement
Pediatric volitional questionnaire (PVQ)

Secondary outcomes

1

Description
Goal achievement
Timepoint
Pretest, post test and follow-up
Method of measurement
Goal Attainment scale (GAS)

2

Description
Performance and satisfaction scores of child-chosen goal
Timepoint
Pretest, post test and follow-up
Method of measurement
Canadian Occupational Performance Measurement (COPM)

Intervention groups

1

Description
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.
Category
Rehabilitation

2

Description
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.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
sourosh school (for physical disabilities)
Full name of responsible person
Mr saeid reisi
Street address
9th Boostan ave / Pasdaran Blv
City
tehran
Province
Tehran
Postal code
1666643134
Phone
+98 21 2257 5566
Email
saeedreese1@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. malahat akbarfahimi
Street address
Occupational Therapy department- School of Rehabilitation Sciences- Madadkaran alley- Shah-Nazari street- Madar square- Mirdamad avenue
City
tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 2059
Email
akbarfahimi.m@iums.ac.ir
Grant name
Research deputy of Iran university of medical sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Zahra Poorzamani Dehkordi
Position
master candidate of Occupational Therapy
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
Occupational Therapy department- School of Rehabilitation Sciences- Madadkaran alley- Shah-Nazari street- Madar square- Mirdamad avenue
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 2059
Email
poorzamani_zp@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Malahat Akbarfahimi
Position
PhD in neuroscience- Faculty of Iran Univercity of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Occupational Therapy department- School of Rehabilitation Sciences- Madadkaran alley- Shah-Nazari street- Madar square- Mirdamad avenue
City
tehran
Province
Tehran
Postal code
1545913478
Phone
+98 21 2222 2059
Email
akbarfahimi.m@iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Zahra Poorzamani Dehkordi
Position
master candidate of Occupational Therapy
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
Occupational Therapy department- School of Rehabilitation Sciences- Madadkaran alley- Shah-Nazari street- Madar square- Mirdamad avenue
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 7124
Email
poorzamani_zp@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Article puplished
When the data will become available and for how long
March 2019
To whom data/document is available
The researcher and occupational therapists
Under which criteria data/document could be used
Other research, critics, check and clinical usage
From where data/document is obtainable
First person in article
What processes are involved for a request to access data/document
Send request by email
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