History
# Registration date Revision Id
3 2018-11-01, 1397/08/10 65819
2 2018-06-09, 1397/03/19 55093
1 2015-07-14, 1394/04/23 11221
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  • Protocol summary

    This study aimed to evaluate and compare the effectiveness of neurofeedback training and perception-motion exercises on sustained attention of children with ADHD 12-5 years old. who selected from Tavenesh rehabilitation center randomly based on the criteria. Inclusion criteria: the diagnosis of hyperactivity / inattention confirmed by a child psychiatrist according to DSM-IV; age 5 to 12 years ; IQ above 70, based on Wechsler's intelligence test ;problems in motor coordination in hyperactivity / inattention ;no other neurological , psychiatric and Orthopedic disorders based on medical records ;normal or corrected vision and hearing based on medical records. Exclusion criteria: quit more than 2 sessions; Changes in drugs regime; infectious disease during the intervention; did not cooperate during the meetings. Sample size consists of 40 ADHD children in two equal groups of 20/20 in neurofeedback training and perceptual motor treatment groups.In intervention group 2 coordination problem assessed by Bruininks Oseretsky test, in order to determine the developmental age 1 year younger than chronological age. Study intervention for each group consists of 20 sessions( 3 sessions per week) during the 7 weeks, each session lasting 45 minutes. At the first and 20th sessions of the treatment sustained attention is assessed by CPT in both groups.
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    هدف بررسی مقایسه ای تاثیر نوروفیدبک و تمرینات درکی–حرکتی کاردرمانی بر توجه پایدارکودکان دارای اختلال بیش فعالی/کم توجهی12-5 سال است. جمعیت مورد مطالعه کودکان بیش فعال همراه با نقص توجه و تمرکز مراجعه کننده به مرکز توانبخشی توانش میباشند که بصورت تصادفی از طریق نمونه گیری در دسترس انتخاب میشوند. معیارهای ورود: تشخیص اختلال بیش فعالی/کم توجهی توسط روانپزشک اطفال و DSM-IV؛ 12-5 سال؛ بهره هوشی بیشتر 70 براساس آزمون هوشی وکسلر؛ وجود مشکلات هماهنگی حرکتی علاوه بر تشخیص بیش فعالی/کم توجهی در گروه مداخله 2؛ عدم ابتلا به هرگونه بیماری نورولوژیک و اختلالات روانپزشکی همراه به تشخیص روانپزشک؛ عدم ابتلا به بیماری ارتوپدیک به تشخیص پزشک کودک؛ داشتن بینایی و شنوایی نرمال براساس پرونده پزشکی. معیارهای خروج: عدم پیگیری مداوم جلسات درمانی بیش از 2 جلسه پیاپی؛ تغییر رژیم دارویی؛ ابتلا به بیماریهای عفونی درطول مداخله؛ عدم همکاری در طول جلسه . 40 کودک شرکت کننده به دو گروه همگن 20 نفره مداخله 1 دریافت کننده درمان نوروفیدبک به صورت مونوپلار و در منطقه سی مرکزی(CZ) و گروه مداخله 2 دریافت کننده تمرینات درکی-حرکتی مطابق با پروتکل جک کیپون تقسیم میشوند. در گروه مداخله 2 هماهنگی حرکتی توسط آزمون کفایت حرکتی برونینکز-اوزرتسکی صورت میگیرد تا کودکان یک سال از سن حرکتی خود عقبتر باشند. هر گروه 20 جلسه درمان مربوط به گروه خود را به صورت هر هفته 3جلسه، هرجلسه به مدت 45 دقیقه و در طول7 هفته دریافت مینمایند. در ابتدای جلسه اول و بیستم هر دو گروه مورد ارزیابی آزمون عملکرد توجه پیوسته قرار می گیرند.
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    This study aimed to evaluate and compare the effectiveness of neurofeedback training and perception-motion exercises on sustained attention of children with ADHD 12-5 years old. .
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    هدف بررسی مقایسه ای تاثیر نوروفیدبک و تمرینات درکی–حرکتی کاردرمانی بر توجه پایدارکودکان دارای اختلال بیش فعالی/کم توجهی12-5 سال است.
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    Two arm parallel group randomised trial with blinded postoperative care and outcome assessment
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    کارآزمایی بالینی دارای گروه کنترل، مبتنی بر جامعه و عمل گرا، با گروه های موازی ، دو سویه کور ، تصادفی شده
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    The study population was selected from hyperactive children with attention deficit who referred to Tehran clinics and in simple random method divided into two groups. Interventions are being conducted at the Tavanesh Rehabilitation Center.
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    جمعیت مورد مطالعه از کودکان بیش فعال همراه با نقص توجه و تمرکز مراجعه کننده به کلینیکهای شهر تهران بطور در دسترس انتخاب و بطور تصادفی ساده به دو گروه مداخله و کنترل تقسیم میشود. مداخلات در مرکز توانبخشی توانش انجام می شود.
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    Inclusion criteria: the diagnosis of hyperactivity / inattention confirmed by a child psychiatrist according to DSM-IV; age 5 to 12 years ; IQ above 70, based on Wechsler's intelligence test ;problems in motor coordination in hyperactivity / inattention ;no other neurological , psychiatric and Orthopedic disorders based on medical records ;normal or corrected vision and hearing based on medical records. Exclusion criteria: quit more than 2 sessions; Changes in drugs regime; infectious disease during the intervention; did not cooperate during the meetings.
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    معیارهای ورود: تشخیص اختلال بیش فعالی/کم توجهی توسط روانپزشک اطفال و DSM-IV؛ 12-5 سال؛ بهره هوشی بیشتر 70 براساس آزمون هوشی وکسلر؛ وجود مشکلات هماهنگی حرکتی علاوه بر تشخیص بیش فعالی/کم توجهی در گروه مداخله 2؛ عدم ابتلا به هرگونه بیماری نورولوژیک و اختلالات روانپزشکی همراه به تشخیص روانپزشک؛ عدم ابتلا به بیماری ارتوپدیک به تشخیص پزشک کودک؛ داشتن بینایی و شنوایی نرمال براساس پرونده پزشکی. معیارهای خروج: عدم پیگیری مداوم جلسات درمانی بیش از 2 جلسه پیاپی؛ تغییر رژیم دارویی؛ ابتلا به بیماریهای عفونی درطول مداخله؛ عدم همکاری در طول جلسه .
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    40 ADHD children in two equal groups of 20/20 in neurofeedback training and perceptual motor treatment groups.In intervention group 1they recieve neurofeedback training in bipolar method at C3 and C4 . Group 2 receives perceptual -motor exercises using JackKapen protocols.In this group coordination problem assessed by Bruininks Oseretsky test, in order to determine the developmental age 1 year younger than chronological age.
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    40 کودک شرکت کننده به دو گروه همگن 20 نفره مداخله 1 دریافت کننده درمان نوروفیدبک به صورت دو قطبی در منطقه سی 3 و 4(C3 و C4) . گروه مداخله 2 دریافت کننده تمرینات درکی-حرکتی مطابق با پروتکل جک کیپون تقسیم میشوند. در گروه مداخله 2 هماهنگی حرکتی توسط آزمون کفایت حرکتی برونینکز-اوزرتسکی صورت میگیرد تا کودکان یک سال از سن حرکتی خود عقبتر باشند.
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    Commission ; Omission ; Reaction time
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    خطای ارایه پاسخ ؛ خطای حذف ؛ زمان واکنش
  • General information

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    2016-01-02, 1394/10/12
    the diagnosis of hyperactivity / inattention confirmed by a child psychiatrist according to DSM-IV
    age 5 to 12 years
    IQ above 70 based on Wechsler's intelligence test
    problems in motor coordination in hyperactivity / inattention
    no other neurological , psychiatric and Orthopedic disorders based on medical records
    no audio or visual disorders based on medical records
    تشخیص اختلال بیش فعالی/کم توجهی توسط روانپزشک اطفال و بر طبق DSM-IV
    سن 5 تا 12 سال
    بهره هوشی بالاتراز 70 براساس آزمون هوشی وکسلر
    دارا بودن مشکلات هماهنگی حرکتی علاوه بر تشخیص بیش فعالی/کم توجهی در گروه درمانی کاردرمانی
    عدم ابتلا به هرگونه بیماری نورولوژیک، ارتوپدیک و اختلالات روانپزشکی همراه به تشخیص روانپزشک
    نداشتن هرگونه اختلالات دیداری یا شنیداری براساس پرونده پزشکی
    Quit more than 2 sessions
    Changes in drugs regime
    Infectious disease during the intervention
    Did not cooperate during the meetings
    عدم پیگیری مداوم جلسات درمانی بیش از 2 جلسه پیاپی
    تغییر رژیم دارویی
    ابتلا به بیماریهای عفونی درطول مداخله
    عدم همکاری در طول جلسه مداخله
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    Participants will select by convenience sampling. Randomizing participants in neurofeedback and perceptual -motor groups will done with randomization digits table by a blind person to the study
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    نمونه ها با بررسی شرایط ورود به صورت در دسترس انتخاب خواهند شد. تخصیص آنها به دو گروه نروفیدبک و تمرینات درکی–حرکتی با استفاده از جدول اعداد تصادفی توسط فردی که به روش پژوهش ناآگاه است, انجام خواهد شد.
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    Participants will blind of the group that are randomized. The outcome assessor is unaware that participants were in which groups of control or intervention. The data will enter in SPSS and statistically analysis by a blind statistician
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    شرکت کننده ها در مطالعه از گروهی که به آن وارد می شوند اطلاعی ندارند. ارزیاب پیامدها از در گروه مداخله و یا کنترل بودن شرکت کننده ناآگاه است. پس از اتمام درمان و تکمیل پرسشنامه ها داده ها توسط فرد ناآگاه از دو گروه درمان وارد SPSS و آنالیز آماری خواهد شد.
  • Intervention groups

    #1
    Intervention group: Treatment occurs in 20 therapy sessions during 3 days in week for 7 weeks. The protocol of Neurofeedback treatment consists of monopolar montage in Cz in the central region .
    Intervention group: Treatment occurs in 20 therapy sessions during 3 days in week for 7 weeks. The protocol of Neurofeedback treatment consists of bipolar montage in C3 & C4 in the central region .
    در گروه مداخله1 :20 جلسه درمانی به صورت هفته ای 3جلسه، هر جلسه به مدت 45 دقیقه و در طول 7 هفته اجرا میگردد درمان نوروفیدبک به صورت مونوپلار و در منطقه سی مرکزی(CZ) انجام میگیرد.
    در گروه مداخله1 :20 جلسه درمانی به صورت هفته ای 3جلسه، هر جلسه به مدت 45 دقیقه و در طول 7 هفته اجرا میگردد درمان نوروفیدبک به صورت بای پولار و در منطقه سی 3. 4(C3 & C4 ) انجام میگیرد
  • Recruitment centers

    #1
    Name of recruitment center - English: Tavanesh rehabilitation center
    Name of recruitment center - Persian: مرکز توانبخشی توانش
    Full name of responsible person - English: Neda Ghadamghahi
    Full name of responsible person - Persian: ندا قدمگاهی
    Street address - English: Azadi street, south Jamalzadeh ,78. unit 4 &5
    Street address - Persian: خیابان آزادی، خیابان جمالزاده جنوبی، پلاک 78، واحد 4 و 5
    City - English: Tehran
    City - Persian: تهران
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    Name of recruitment center - English: Tehran occupational Therapy cilincs
    Name of recruitment center - Persian: کلینیکهای کاردرمانی شهر تهران
    Full name of responsible person - English: Neda Ghadamghahi
    Full name of responsible person - Persian: ندا قدمگاهی
    Street address - English: Azadi street, south Jamalzadeh ,78. unit 4 &5
    Street address - Persian: خیابان آزادی، خیابان جمالزاده جنوبی، پلاک 78، واحد 4 و 5
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1313815867
    Phone: +98 21 2222 7124
    Fax:
    Email: akbarfahimi.m@iums.acir
    Web page address:
  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Iran University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی ایران
    Full name of responsible person - English: Dr Seyed Ali Javad Moosavi
    Full name of responsible person - Persian: دكتر سيد علي جواد موسوي
    Street address - English: Hemmat Highway, between Chamran and Sheikh Fadlallah, Iran University of Medical Sciences
    Street address - Persian: بزرگراه همت، بين چمران و شيخ فضل الله، دانشگاه علوم پزشکی ايران
    City - English: Tehran
    City - Persian: تهران
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Iran University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی ایران
    Full name of responsible person - English: Dr Seyed Ali Javad Moosavi
    Full name of responsible person - Persian: دكتر سيد علي جواد موسوي
    Street address - English: Hemmat Highway, between Chamran and Sheikh Fadlallah, Iran University of Medical Sciences
    Street address - Persian: بزرگراه همت، بين چمران و شيخ فضل الله، دانشگاه علوم پزشکی ايران
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 14665-354
    Phone: +98 21 86709
    Fax:
    Email: akbarfahimi.m@iums.ac.ir
    Web page address:
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    Public
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    Domestic
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    Academic
  • Person responsible for general inquiries

    contact.organization_id:
    Name of organization / entity - English: Iran University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی ایران
    Full name of responsible person - English: Dr. Malahat Akbarfahimi
    Full name of responsible person - Persian: دکتر ملاحت اکبرفهیمی
    Position - English: Assisstant Professor, Master of occupational therapy- PhD of cognitive neurosciences
    Position - Persian: استادیار، دکترا
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: rehabilitation faculty, Nezam Aly-shah nazari street, Madar square, Mirdamad blvd
    Street address - Persian: بلوار میرداماد، میدان مادر، خیابان شاه نظری، کوچه نظام
    City - English: Tehran
    City - Persian: تهران
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 21 2222 7124
    Mobile: 00
    Fax:
    Email: akbarfahimi.m@iums.ac.ir
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Iran University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی ایران
    Full name of responsible person - English: Dr. Malahat Akbarfahimi
    Full name of responsible person - Persian: دکتر ملاحت اکبرفهیمی
    Position - English: Assisstant Professor, Master of occupational therapy- PhD of cognitive neurosciences
    Position - Persian: استادیار، دکترا
    Latest degree: phd
    Area of specialty/work: 63
    Area of specialty/work title - English: Occcupational Therapy
    Area of specialty/work title - Persian: کاردرمانی
    Street address - English: rehabilitation faculty, Nezam Aly-shah nazari street, Madar square, Mirdamad blvd
    Street address - Persian: بلوار میرداماد، میدان مادر، خیابان شاه نظری، کوچه نظام
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 158754391
    Phone: +98 21 2222 7124
    Mobile: +91 23362925
    Fax:
    Email: akbarfahimi.m@iums.ac.ir
    Web page address:
  • Person responsible for scientific inquiries

    contact.organization_id:
    Name of organization / entity - English: Iran University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی ایران
    Full name of responsible person - English: Dr Malahat Akbarfahimi
    Full name of responsible person - Persian: دکتر ملاحت اکبرفهیمی
    Position - English: Assisstant Professor/Phd of cognitive neuroscience-MS occupational therapy
    Position - Persian: استادیار، دکترای علوم اعصاب شناختی- کارشناسی ارشد کاردرمانی
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Rehabilitation faculty, Nezam Aly-shah nazari street, madar square, Mirdamad blvd
    Street address - Persian: بلوار میرداماد،میدان مادر،خیابان شاه نظری،کوچه ی نظام
    City - English: Tehran
    City - Persian: تهران
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 21 2222 7124
    Mobile: +98 921 336 2925
    Fax:
    Email: akbarfahimi.m@iums.ac.ir
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Iran University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی ایران
    Full name of responsible person - English: Dr Malahat Akbarfahimi
    Full name of responsible person - Persian: دکتر ملاحت اکبرفهیمی
    Position - English: Assisstant Professor/Phd of cognitive neuroscience-MS occupational therapy
    Position - Persian: استادیار، دکترای علوم اعصاب شناختی- کارشناسی ارشد کاردرمانی
    Latest degree: phd
    Area of specialty/work: 63
    Area of specialty/work title - English: occupational therapy
    Area of specialty/work title - Persian: کاردرمانی
    Street address - English: Rehabilitation faculty, Nezam Aly-shah nazari street, madar square, Mirdamad blvd
    Street address - Persian: بلوار میرداماد،میدان مادر،خیابان شاه نظری،کوچه ی نظام
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 158754391
    Phone: +98 21 2222 7124
    Mobile: +98 921 336 2925
    Fax:
    Email: akbarfahimi.m@iums.ac.ir
    Web page address:
  • Person responsible for updating data

    contact.organization_id:
    Name of organization / entity - English: Iran University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی ایران
    Full name of responsible person - English: Dr. Malahat Akbarfahimi
    Full name of responsible person - Persian: دکتر ملاحت اکبرفهیمی
    Position - English: Assisstant Professor/Phd of cognitive neuroscience-MS occupational therapy
    Position - Persian: استادیار، دکترا علوم اعصاب شناختی- کارشناسی ارشد کاردرمانی
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Rehabilitation faculty, Nezam Aly-shah nazari street, Madar square, Mirdamad blvd
    Street address - Persian: بلوار میرداماد، میدان مادر، خیابان شاه نظری، خیابان نظام
    City - English: Tehran
    City - Persian: تهران
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 21 2222 7124
    Mobile: +98 921 336 2925
    Fax:
    Email: akbarfahimi.m@iums.ac.ir
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Iran University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی ایران
    Full name of responsible person - English: Dr. Malahat Akbarfahimi
    Full name of responsible person - Persian: دکتر ملاحت اکبرفهیمی
    Position - English: Assisstant Professor/Phd of cognitive neuroscience-MS occupational therapy
    Position - Persian: استادیار، دکترا علوم اعصاب شناختی- کارشناسی ارشد کاردرمانی
    Latest degree: phd
    Area of specialty/work: 72
    Area of specialty/work title - English: Cognitive Neuroscience
    Area of specialty/work title - Persian: علوم اعصاب شناختی
    Street address - English: Rehabilitation faculty, Nezam Aly-shah nazari street, Madar square, Mirdamad blvd
    Street address - Persian: بلوار میرداماد، میدان مادر، خیابان شاه نظری، خیابان نظام
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 158754391
    Phone: +98 21 2222 7124
    Mobile: +98 921 336 2925
    Fax:
    Email: akbarfahimi.m@iums.ac.ir
    Web page address:
  • Sharing plan

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    اطلاعات بیشتری وجود ندارد

Protocol summary

Study aim
This study aimed to evaluate and compare the effectiveness of neurofeedback training and perception-motion exercises on sustained attention of children with ADHD 12-5 years old. .
Design
Two arm parallel group randomised trial with blinded postoperative care and outcome assessment
Settings and conduct
The study population was selected from hyperactive children with attention deficit who referred to Tehran clinics and in simple random method divided into two groups. Interventions are being conducted at the Tavanesh Rehabilitation Center.
Participants/Inclusion and exclusion criteria
Inclusion criteria: the diagnosis of hyperactivity / inattention confirmed by a child psychiatrist according to DSM-IV; age 5 to 12 years ; IQ above 70, based on Wechsler's intelligence test ;problems in motor coordination in hyperactivity / inattention ;no other neurological , psychiatric and Orthopedic disorders based on medical records ;normal or corrected vision and hearing based on medical records. Exclusion criteria: quit more than 2 sessions; Changes in drugs regime; infectious disease during the intervention; did not cooperate during the meetings.
Intervention groups
40 ADHD children in two equal groups of 20/20 in neurofeedback training and perceptual motor treatment groups.In intervention group 1they recieve neurofeedback training in bipolar method at C3 and C4 . Group 2 receives perceptual -motor exercises using JackKapen protocols.In this group coordination problem assessed by Bruininks Oseretsky test, in order to determine the developmental age 1 year younger than chronological age.
Main outcome variables
Commission ; Omission ; Reaction time

General information

Reason for update
Acronym
ADHD
IRCT registration information
IRCT registration number: IRCT2015061910806N2
Registration date: 2015-07-14, 1394/04/23
Registration timing: prospective

Last update: 2018-08-03, 1397/05/12
Update count: 2
Registration date
2015-07-14, 1394/04/23
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
Deputy of Research, Iran University of Medical Sciences
Expected recruitment start date
2015-07-06, 1394/04/15
Expected recruitment end date
2015-09-23, 1394/07/01
Actual recruitment start date
2015-09-18, 1394/06/27
Actual recruitment end date
2016-01-02, 1394/10/12
Trial completion date
empty
Scientific title
Comparison of neurofeedback training and perceptual-motor therapy on sustained attention in children with Attention deficit hyperactivity disorder 5-12 years
Public title
Comparison of neurofeedback training and perceptual motor exercises
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
the diagnosis of hyperactivity / inattention confirmed by a child psychiatrist according to DSM-IV age 5 to 12 years IQ above 70 based on Wechsler's intelligence test problems in motor coordination in hyperactivity / inattention no other neurological , psychiatric and Orthopedic disorders based on medical records no audio or visual disorders based on medical records
Exclusion criteria:
Quit more than 2 sessions Changes in drugs regime Infectious disease during the intervention Did not cooperate during the meetings
Age
From 5 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: 40
Actual sample size reached: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will select by convenience sampling. Randomizing participants in neurofeedback and perceptual -motor groups will done with randomization digits table by a blind person to the study
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants will blind of the group that are randomized. The outcome assessor is unaware that participants were in which groups of control or intervention. The data will enter in SPSS and statistically analysis by a blind statistician
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Iran university of Medical Sciences
Street address
Hemmat Highway, between Chamran and Sheikh Fadlallah, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2014-09-24, 1393/07/02
Ethics committee reference number
3058/105/د/93

Health conditions studied

1

Description of health condition studied
Hyperactivity/inattention
ICD-10 code
F90.0
ICD-10 code description
Disturbance of activity and attention

Primary outcomes

1

Description
Commision
Timepoint
pre intervention(first session)-post intervention(20th session))
Method of measurement
Computerized Continuos performance test

2

Description
Ommision
Timepoint
pre intervention(first session)-post intervention(20th session))
Method of measurement
Computerized Continuos performance test

3

Description
Reaction time
Timepoint
pre intervention(first session)-post intervention(20th session))
Method of measurement
Computerized Continuos performance test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Treatment occurs in 20 therapy sessions during 3 days in week for 7 weeks. The protocol of Neurofeedback treatment consists of bipolar montage in C3 & C4 in the central region .
Category
Rehabilitation

2

Description
Intervention group2: Treatment occurs in 20 therapy sessions, 45 minutes ,during 3 days in week for 7 weeks . Perceptual motor exercises demonstrate and including the timing, sequence, rhythm and movement which are planned by Jack Kypvn protocol.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Tehran occupational Therapy cilincs
Full name of responsible person
Neda Ghadamghahi
Street address
Azadi street, south Jamalzadeh ,78. unit 4 &5
City
Tehran
Province
Tehran
Postal code
1313815867
Phone
+98 21 2222 7124
Email
akbarfahimi.m@iums.acir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Seyed Ali Javad Moosavi
Street address
Hemmat Highway, between Chamran and Sheikh Fadlallah, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
14665-354
Phone
+98 21 86709
Email
akbarfahimi.m@iums.ac.ir
Grant name
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
Dr. Malahat Akbarfahimi
Position
Assisstant Professor, Master of occupational therapy- PhD of cognitive neurosciences
Latest degree
Ph.D.
Other areas of specialty/work
Occcupational Therapy
Street address
rehabilitation faculty, Nezam Aly-shah nazari street, Madar square, Mirdamad blvd
City
Tehran
Province
Tehran
Postal code
158754391
Phone
+98 21 2222 7124
Fax
Email
akbarfahimi.m@iums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Malahat Akbarfahimi
Position
Assisstant Professor/Phd of cognitive neuroscience-MS occupational therapy
Latest degree
Ph.D.
Other areas of specialty/work
occupational therapy
Street address
Rehabilitation faculty, Nezam Aly-shah nazari street, madar square, Mirdamad blvd
City
Tehran
Province
Tehran
Postal code
158754391
Phone
+98 21 2222 7124
Fax
Email
akbarfahimi.m@iums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Malahat Akbarfahimi
Position
Assisstant Professor/Phd of cognitive neuroscience-MS occupational therapy
Latest degree
Ph.D.
Other areas of specialty/work
Cognitive Neuroscience
Street address
Rehabilitation faculty, Nezam Aly-shah nazari street, Madar square, Mirdamad blvd
City
Tehran
Province
Tehran
Postal code
158754391
Phone
+98 21 2222 7124
Fax
Email
akbarfahimi.m@iums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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