Protocol summary
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Study aim
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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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Design
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Two arm parallel group randomised trial with blinded postoperative care and outcome assessment
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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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Intervention groups
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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 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.
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Main outcome variables
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Commission ; Omission ; Reaction time
General information
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Reason for update
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Acronym
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ADHD
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IRCT registration information
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IRCT registration number:
IRCT2015061910806N2
Registration date:
2015-07-14, 1394/04/23
Registration timing:
registered_while_recruiting
Last update:
2018-11-04, 1397/08/13
Update count:
2
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Registration date
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2015-07-14, 1394/04/23
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Deputy of Research, Iran University of Medical Sciences
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Expected recruitment start date
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2015-07-06, 1394/04/15
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Expected recruitment end date
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2015-09-23, 1394/07/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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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Public title
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Comparison of neurofeedback training and perceptual motor exercises
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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
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Age
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From 5 years old to 12 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
40
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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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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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2014-09-24, 1393/07/02
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Ethics committee reference number
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3058/105/د/93
Health conditions studied
1
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Description of health condition studied
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Hyperactivity/inattention
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ICD-10 code
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F90.0
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ICD-10 code description
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Disturbance of activity and attention
Primary outcomes
1
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Description
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Commision
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Timepoint
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The day before the first intervention session- The day after the last intervention session
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Method of measurement
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Computerized Continuos performance test
2
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Description
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Ommision
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Timepoint
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The day before the first intervention session- The day after the last intervention session
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Method of measurement
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Computerized Continuos performance test
3
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Description
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Reaction time
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Timepoint
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The day before the first intervention session- The day after the last intervention session
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Method of measurement
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Computerized Continuos performance test
Secondary outcomes
1
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Description
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Perceptual-motor skills
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Timepoint
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The day before the first intervention session- The day after the last intervention session
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Method of measurement
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Bruininks-Oseretsky Test of Motor Proficiency
Intervention groups
1
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Description
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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 .
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Category
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Rehabilitation
2
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Description
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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.
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Iran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available