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
Changes made to previous revision
This is the first revision

Protocol summary

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.

General information

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

Last update:
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
empty
Actual recruitment end date
empty
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 4 years old to 11 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
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
Postal code
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 monopolar 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
Tavanesh rehabilitation center
Full name of responsible person
Neda Ghadamghahi
Street address
Azadi street, south Jamalzadeh ,78. unit 4 &5
City
Tehran

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
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
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

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
Other areas of specialty/work
Street address
rehabilitation faculty, Nezam Aly-shah nazari street, Madar square, Mirdamad blvd
City
Tehran
Postal code
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
Other areas of specialty/work
Street address
Rehabilitation faculty, Nezam Aly-shah nazari street, madar square, Mirdamad blvd
City
Tehran
Postal code
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
Other areas of specialty/work
Street address
Rehabilitation faculty, Nezam Aly-shah nazari street, Madar square, Mirdamad blvd
City
Tehran
Postal code
Phone
+98 21 2222 7124
Fax
Email
akbarfahimi.m@iums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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