Comparison of the Effectiveness of Perceptual-Motor Training and tDCS on Executive Functions and Motor Skills in Children with Attention Deficit Hyperactivity Disorder (ADHD)
Comparison and Differences Between Perceptual-Motor Training and tDCS on Executive Functions and Motor Skills in Children with Attention Deficit Hyperactivity Disorder
Design
The total sample size consists of 45 participants, divided into three groups of 15. Two groups will receive the training, while one control group will be randomly assigned. The study will be conducted in parallel groups in a semi-clinical manner.
Settings and conduct
This research will be conducted in a clinic that has children with Attention Deficit Hyperactivity Disorder (ADHD).
Participants/Inclusion and exclusion criteria
Children with Attention Deficit Hyperactivity Disorder (ADHD), aged 7 to 10 years
Intervention groups
Perceptual-motor exercises
The transcranial direct current stimulation
Main outcome variables
Memory with N-BACK test: cognitive acceptance task with Wisconsin test: response inhibition with Stroop test and motor skills with Ulrich test
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250208064687N1
Registration date:2025-04-16, 1404/01/27
Registration timing:prospective
Last update:2025-04-16, 1404/01/27
Update count:0
Registration date
2025-04-16, 1404/01/27
Registrant information
Name
Reza Shadfar
Name of organization / entity
University of Tehran
Country
Iran (Islamic Republic of)
Phone
+98 87 3328 9192
Email address
reza.shadfar@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-04-20, 1404/01/31
Expected recruitment end date
2025-06-21, 1404/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Perceptual-Motor Training and tDCS on Executive Functions and Motor Skills in Children with Attention Deficit Hyperactivity Disorder (ADHD)
Public title
The Effect of Perceptual-Motor Training and tDCS on Executive Function and Motor Skills in Children with ADHD
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
With ADHD Disorder
Exclusion criteria:
Having Other Diseases and Disorders
Range outside the age range of 7-10 years
Age
From 7 years old to 10 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Simple Randomization Using SPSS Software
The following steps will be followed for simple randomization using SPSS software:
First, a random variable will be created using the Transform > Compute Variable tool. This variable will be defined using the formula Trunc(RV.Uniform(0,1)*3)+1, which randomly assigns individuals to one of three groups (1, 2, or 3).
The data will then be sorted based on this variable using the Data > Sort Cases tool.
Finally, participants will be randomly divided into three groups: the control group (number 1) and two experimental groups (numbers 2 and 3).
This method is a simple and transparent form of randomization, which will be used in the future for the implementation of the study.
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
Research Ethics Committee of Islamic Azad University, Sari Branch
Street address
Pasdaran Street, Kamal Elmak Street, Gino Complex
City
sanandaj
Province
Kurdistan
Postal code
6617635413
Approval date
2024-07-30, 1403/05/09
Ethics committee reference number
IR.IAU.SARI.REC.1403.219
Health conditions studied
1
Description of health condition studied
Attention Deficit Hyperactivity Disorder
ICD-10 code
F90.0
ICD-10 code description
Attention-deficit hyperactivity disorder, predominantly inattentive type
Primary outcomes
1
Description
Motor skills
Timepoint
Before the start of the intervention and after 8 weeks of intervention
Method of measurement
Ulrich Test (Third Edition)
2
Description
working memory
Timepoint
Before the start of the intervention and after 8 weeks of intervention
Method of measurement
N-Back Test
3
Description
Cognitive flexibility
Timepoint
Before the start of the intervention and after 8 weeks of intervention
Method of measurement
Wisconsin test
4
Description
Response inhibition
Timepoint
Before the start of the intervention and after 8 weeks of intervention
Method of measurement
Stroop test
Secondary outcomes
empty
Intervention groups
1
Description
The study was conducted in accordance with the latest version of the Declaration of Helsinki and approved by the Ethics Committee of the University of Tehran. The method of collecting data for the present study was fieldwork. Initially, written informed consent was obtained from the parents. Children also verbally expressed their willingness to participate in the study. Then, the participants were introduced to the objectives of the study and the scoring and implementation of the desired tests. Subsequently, the participants were randomly assigned to one of the tDCS stimulation group (1) and perceptual-motor training group (2). The present study included pre-test, intervention (practice), and post-test stages. Assessments were conducted before the start of the interventions and in the session after the interventions by another occupational therapist. This assessor was unaware of the objectives and content of the sessions during the study process, and after familiarization, in the pre-test stage, the Ulrich test (3rd edition) and the executive functions test (Stroop, Wisconsin, and N-back) were administered to the children in accordance with the existing guidelines, and then the parents completed the standard ADHD questionnaire. The intervention phase was conducted in 24 sessions. In the tDCS direct electrical stimulation group, participants received 24 sessions of 30-minute electrical stimulation of the DLPFC (F4-F3) and the primary motor cortex (M1) (C4-C3) (in this way, in anodic electrical stimulation, a direct current of 1.5 milliamperes is applied to the individual throughout the entire duration of the stimulation). The sessions were conducted 3 days a week. In the perceptual-motor training group, which was also conducted in 24 sessions of 45 minutes each session, 3 days a week, the participants performed the relevant exercises. The 10-20 International System was used to find the points. Immediately after the last session, the post-test phase was conducted in which the participants performed the desired tests.
Category
Behavior
2
Description
Control group: Group 3 was the control group, which received no intervention.
Category
Behavior
3
Description
Intervention group: Intervention group: Perceptual-motor exercises: The present study included pre-test, intervention (practice), and post-test phases. Assessments were conducted by another occupational therapist before the intervention and in the session after the intervention. The subjects were unaware of the concepts and content of the sessions during the study process, and after familiarization, in the pre-test phase, the Ulrich test (3rd edition) and the executive functions test (Stroop, Wisconsin, and N-back) were administered according to the existing instructions, and then the parents completed the standard attention deficit hyperactivity disorder questionnaire. The intervention phase consisted of 24 sessions. In the perceptual-motor exercises group, which was conducted in 24 sessions, each session lasting 45 minutes, 3 days a week, the participants performed the exercises. After the last session, the post-test phase was conducted in which the participants performed the desired tests.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic Alan
Full name of responsible person
Zahad Mantashloo
Street address
12، 1/17 ،bahran
City
Sanandaj
Province
Kurdistan
Postal code
6617721456
Phone
+98 87 3328 9192
Email
rezashadfar24@yahoo.co.uk
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Tehran
Full name of responsible person
Mohmod Shihk
Street address
North 15th Street Worker
City
Tahran
Province
Tehran
Postal code
21457489676
Phone
+98 21 8882 3436
Email
rezashadfar24@yahoo.co.uk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
خود شخص مسول
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
University of Tahran
Full name of responsible person
Reza Shadfar
Position
Professor of the Right to teach
Latest degree
Master
Other areas of specialty/work
Sport Medicine
Street address
Gino Complex,Kamal Elmak Street, Pasdaran Street,
City
Sanandaj
Province
Kurdistan
Postal code
6617635413
Phone
+98 87 3328 9192
Email
reza.shadfar@ut.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Tehran
Full name of responsible person
Reza Shadfar
Position
Professor of the Right to teach
Latest degree
Master
Other areas of specialty/work
Sport Medicine
Street address
Zino Complex, Kamal-ol-Molk Street, Pasdaran Street
City
Sanandaj
Province
Kurdistan
Postal code
6617635413
Phone
+98 87 3328 9192
Email
rezashadfar24@yahoo.co.uk
Person responsible for updating data
Contact
Name of organization / entity
University of Tahran
Full name of responsible person
Reza Shadfar
Position
Professor Right to Teach
Latest degree
Master
Other areas of specialty/work
Sport Medicine
Street address
Gino Complex Kamal-ol-Molk Street Pasdaran Street
City
Sanandaj
Province
Kurdistan
Postal code
6617635413
Phone
+98 87 3328 9192
Email
rezashadfar24@yahoo.co.uk
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