Comparison of neurofeedback training and perceptual-motor therapy on sustained attention in children with Attention deficit hyperactivity disorder 5-12 years
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Protocol summary
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.
The study population was selected from hyperactive children with attention deficit who referred to Tehran pediatric's hospitals and in simple random method divided into two groups. Interventions are being conducted at the Tavanesh Rehabilitation Center.
The study population was selected from hyperactive children with attention deficit who referred to Tehran clinicspediatric's hospitals and in simple random method divided into two groups. Interventions are being conducted at the Tavanesh Rehabilitation Center.
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.
جمعیت مورد مطالعه از کودکان بیش فعال همراه با نقص توجه و تمرکز مراجعه کننده به بیمارستانهای اطفال 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.
جمعیت مورد مطالعه از کودکان بیش فعال همراه با نقص توجه و تمرکز مراجعه کننده به کلینیکهایبیمارستانهای اطفال 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.
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.
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 unipolar method at Cz . 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.
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 bipolarunipolar method at C3 and C4Cz . 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.
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.
40 کودک شرکت کننده به دو گروه همگن 20 نفره مداخله 1 دریافت کننده درمان نوروفیدبک به صورت تک قطبی در منطقه سی مرکزی(Cz) . 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 برونینکس-اوزرتسکی صورت میگیرد تا کودکان یک سال از سن حرکتی خود عقبتر باشند.
40 کودک شرکت کننده به دو گروه همگن 20 نفره مداخله 1 دریافت کننده درمان نوروفیدبک به صورت دوتک قطبی در منطقه سی 3 و 4(C3 و C4مرکزی(Cz) . 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 برونینکزبرونینکس-اوزرتسکی صورت میگیرد تا کودکان یک سال از سن حرکتی خود عقبتر باشند.
General information
Double blinded
Single blinded
doublsingl
1
1
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
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
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
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.
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.
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.
Primary outcomes
#1
pre intervention(first session)-post intervention(20th session))
The day before the first intervention session- The day after the last intervention session
pre intervention(firstThe day before the first intervention session)-post intervention(20th The day after the last intervention session))
قبل از مداخله (ابتدای جلسه اول)و پس از مداخله(انتهای جلسه بیستم)
یک روز قبل از شروع مداخله - یک روز پس از آخرین جلسه مداخله
یک روز قبل از شروع مداخله (ابتدای جلسه اول)و- یک روز پس از مداخله(انتهایآخرین جلسه بیستم)مداخله
#2
pre intervention(first session)-post intervention(20th session))
The day before the first intervention session- The day after the last intervention session
pre intervention(firstThe day before the first intervention session)-post intervention(20th The day after the last intervention session))
قبل از مداخله (ابتدای جلسه اول)و پس از مداخله(انتهای جلسه بیستم)
یک روز قبل از شروع مداخله-یک روز پس از آخرین جلسه مداخله
یک روز قبل از شروع مداخله (ابتدای جلسه اول)و-یک روز پس از مداخله(انتهایآخرین جلسه بیستم)مداخله
#3
pre intervention(first session)-post intervention(20th session))
The day before the first intervention session- The day after the last intervention session
pre intervention(firstThe day before the first intervention session)-post intervention(20th The day after the last intervention session))
قبل از مداخله (ابتدای جلسه اول)و پس از مداخله(انتهای جلسه بیستم)
یک روز قبل از شروع مداخله-یک روز پس از آخرین جلسه مداخله
یک روز قبل از شروع مداخله (ابتدای جلسه اول)و-یک روز پس از مداخله(انتهایآخرین جلسه بیستم)مداخله
Secondary outcomes
#1
empty
Perceptual-motor skills
Perceptual-motor skills
empty
مهارت درکی- حرکتی
مهارت درکی- حرکتی
empty
The day before the first intervention session- The day after the last intervention session
The day before the first intervention session- The day after the last intervention session
empty
یک روز قبل از شروع مداخله-یک روز پس از آخرین جلسه مداخله
یک روز قبل از شروع مداخله-یک روز پس از آخرین جلسه مداخله
empty
Bruininks-Oseretsky Test of Motor Proficiency
Bruininks-Oseretsky Test of Motor Proficiency
empty
آزمون برونیکس اوزرنسکی
آزمون برونیکس اوزرنسکی
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 bipolar montage in C3 & C4 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 unipolar 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 bipolarunipolar montage in C3 & C4Cz 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 بای پولار و در منطقه سی 3. 4(C3 & C4 ) 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 تک قطبی 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 پولارتک قطبی و در منطقه سی 3. 4(C3 & C4مرکزی (Cz ) انجام میگیرد
Recruitment centers
#1
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:
Name of recruitment center - English: Tehran pediatric's hospitals
Name of recruitment center - Persian: بیمارستانهای اطفال 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: n_sani87@yahoo.com
Web page address:
Name of recruitment center - English: Tehran occupational Therapy cilincspediatric's hospitals Name of recruitment center - Persian: کلینیکهای کاردرمانیبیمارستانهای اطفال 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.mn_sani87@iums.aciryahoo.com Web page address:
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 pediatric's hospitals 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 unipolar method at Cz . 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:2018-11-04, 1397/08/13
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
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)
Single blinded
Blinding description
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
The day before the first intervention session- The day after the last intervention session
Method of measurement
Computerized Continuos performance test
2
Description
Ommision
Timepoint
The day before the first intervention session- The day after the last intervention session
Method of measurement
Computerized Continuos performance test
3
Description
Reaction time
Timepoint
The day before the first intervention session- The day after the last intervention session
Method of measurement
Computerized Continuos performance test
Secondary outcomes
1
Description
Perceptual-motor skills
Timepoint
The day before the first intervention session- The day after the last intervention session
Method of measurement
Bruininks-Oseretsky Test of Motor Proficiency
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 unipolar montage in Cz 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 pediatric's hospitals
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
n_sani87@yahoo.com
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