Protocol summary

Study aim
the effects of cognitive rehabilitation training, physical and physical and cognitive training on sustained attention, selective attention and shifting attention of children
Design
Clinical trial with control group, with parallel groups, Not blinded , Simple randomization on 40 patients
Settings and conduct
Nine to 12 years old primary school girls with attention deficit / hyperactivity disorder who were referred to Imam Hossein Counseling and Psychological Services Center in Yazd were selected. Then they were randomly divided into control and intervention groups. The attendees trained for 16 minutes and each session for 60 minutes. Posttest was performed 24 and 72 hours later.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. Age between 9 to 12 years old; 2. Attention Deficit/Hyperactivity Disorder; 3. Willingness to participate in the study (consent from parents); 4. Not using stimulants to treat ADHD Exclusion criteria: 1. Absence of more than two sessions in the research process; 2. Changing treatment status and medication use
Intervention groups
There were three experimental groups and one control group. Cognitive rehabilitation training, physical training, concurrent training rehabilitation training (cognitive and physical training)
Main outcome variables
Sustained attention, Selective attention, shifting attention

General information

Reason for update
Acronym
ADHD
IRCT registration information
IRCT registration number: IRCT20180618040143N1
Registration date: 2020-11-03, 1399/08/13
Registration timing: retrospective

Last update: 2020-11-03, 1399/08/13
Update count: 0
Registration date
2020-11-03, 1399/08/13
Registrant information
Name
Mandana Sangari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4496 5441
Email address
mandana.sangari@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-30, 1398/10/09
Expected recruitment end date
2020-01-10, 1398/10/20
Actual recruitment start date
2019-12-30, 1398/10/09
Actual recruitment end date
2020-01-15, 1398/10/25
Trial completion date
2020-03-05, 1398/12/15
Scientific title
Effect of Cognitive Rehabilitation Training, Physical Training and Concurrent Training (Cognitive Rehabilitation Games and Physical Training) on Sustained, Selective and Shifting Attentions of Hyperactive Children
Public title
Effect of Cognitive and Physical Rehabilitation Training on Hyperactive Children Attention
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 9 to 12 years old Attention Deficit/Hyperactivity Disorder Willingness to participate in the study (consent from parents) Not using stimulants to treat ADHD
Exclusion criteria:
Absence of more than two sessions in the research process Changing treatment status and medication use
Age
From 9 years old to 12 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 55
Actual sample size reached: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random using a random numbers table
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Sport Sciences Research Institute of Iran
Street address
No. 3, 5th Alley, Miremad Street, Motahhari Street, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1587958711
Approval date
2019-07-14, 1398/04/23
Ethics committee reference number
IR.SSRC.REC.1399.086

Health conditions studied

1

Description of health condition studied
attention deficit hyperactivity
ICD-10 code
F90.9
ICD-10 code description
Attention-deficit hyperactivity disorder, unspecified type

Primary outcomes

1

Description
Sustained attention
Timepoint
One day before the start of the training intervention (pre-test) and after the last training session (post-test)
Method of measurement
The Integrated Visual and Auditory (IVA) Continuous Performance Test (CPT)

2

Description
Selective attention
Timepoint
One day before the start of the training intervention (pre-test) and after the last training session (post-test)
Method of measurement
Stroop test

3

Description
Shifting attention
Timepoint
One day before the start of the training intervention (pre-test) and after the last training session (post-test)
Method of measurement
Wisconsin Card Sorting Test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: In the pre-test, Integrated Visual and Auditory Continuous Performance Test, Wisconsin Card Sorting Test and Stroop test will be taken. The cognitive rehabilitation program includes the implementation of working memory training software in 16 sessions of 60 minutes at the school and the sessions will be held intensively 3 sessions per week. Then the post-test will be similar to the pre-test.
Category
Rehabilitation

2

Description
Intervention group 2: In the pre-test, Integrated Visual and Auditory Continuous Performance Test, Wisconsin Card Sorting Test and Stroop test will be taken. The training protocol includes games such as chair play, game train, helmet game, jump in the ring, hand gesture movement in 16 sessions of 60 minutes at the school and the sessions will be held intensively 3 sessions per week. Then the post-test will be similar to the pre-tes
Category
Rehabilitation

3

Description
Intervention group 3: In the pre-test, Integrated Visual and Auditory Continuous Performance Test, Wisconsin Card Sorting Test and Stroop test will be taken. The Cognitive Rehabilitation and Physical Training program consists of a combination of two programs that are performed in one training session in such a way that 30 minutes of cognitive rehabilitation training protocol and 30 minutes of physical training protocol. 16 sessions of 60 minutes are taught at the school and the sessions will be held intensively 3 sessions per week. Then the post-test will be similar to the pre-tes
Category
Rehabilitation

4

Description
Control group: The control group was followed up and did not receive any intervention.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
schools in the city of Yazd
Full name of responsible person
Mandana Sangari
Street address
No. 14, , Behnam Alley 12, Behnam St., Ayatollah Kashani Blvd.,
City
Tehran
Province
Tehran
Postal code
1471856151
Phone
+98 21 4496 5441
Email
mandana.sangari@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
mandana sangari
Street address
17 shahrivar Ave
City
Chalous
Province
Mazandaran
Postal code
4661961367
Phone
+98 11 5224 8782
Email
mandana.sangari@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Islamic Azad University, Chalous Branch
Proportion provided by this source
40
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
Islamic Azad University
Full name of responsible person
Mandana Sangari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
17 shahrivar Ave
City
Chalous
Province
Mazandaran
Postal code
4661961367
Phone
+98 11 5224 8782
Email
mandana.sangari@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mandana Sangari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
17 sharivar Ave
City
Chalous
Province
Mazandaran
Postal code
4661961367
Phone
+98 11 5224 8782
Email
mandana.sangari@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
mandana sangari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
17 shahrivar Ave
City
Chalous
Province
Mazandaran
Postal code
4661961367
Phone
+98 11 5224 8782
Email
mandana.sangari@gmail.com

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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