The aim is to compare the effect of eight weeks of perceptual motor exercises on executive functions and learning motor skills of children with mental disabilities.
Design
A clinical trial with a control group, with a parallel group, simple randomized on 30 people with mental retardation, which will be used for randomization from the table of random numbers.
Settings and conduct
The letter of introduction will be sent to the management of exceptional education in the target province and city by the university. By studying the medical records of the subjects, and the necessary conditions and criteria for entering and not entering the research, simple randomization will be done first, and then people will be randomly divided into 2 groups. First, the dependent variables will be evaluated first. Then the interventions will be implemented for 8 weeks and finally re-evaluated in the post-test.
Participants/Inclusion and exclusion criteria
Obtaining consent from parents and individual satisfaction, IQ score 50 to 70, being right-handed, not having physical disability or disability, not having cardiovascular problems and not having autism problems and other problems that affect cognitive development, including entry conditions. Students and parents withdrawing from the research and not participating in the training sessions, pretest and post-test stages will be part of the criteria for withdrawing from the research.
Intervention groups
The intervention group underwent perceptual movement exercises for 8 days and the control group did not implement exercise programs
Main outcome variables
executive functions and learning motor skills.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240805062657N1
Registration date:2024-08-13, 1403/05/23
Registration timing:prospective
Last update:2024-08-13, 1403/05/23
Update count:0
Registration date
2024-08-13, 1403/05/23
Registrant information
Name
Farzad Mohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 5336 0112
Email address
farzad.mohammadi@iau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-20, 1403/05/30
Expected recruitment end date
2024-10-21, 1403/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of eight weeks of perceptual-motor exercises on the executive functions and learning motor skills of mentally retarded children.
Public title
The effect of eight weeks of perceptual-motor exercises on the executive functions and learning motor skills of mentally retarded children.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Obtaining consent from parents and individual satisfaction
IQ score 50 to 70
being right-handed
not having defects or physical disability
not having cardiovascular problems
not having autism problems and other problems that affect cognitive development
not having other problems that affect cognitive development
Age 7 to 10 years
Exclusion criteria:
The withdrawal of students and parents at every stage of the research
not participating in practice sessions
not participating in pretest stage
not participating in post-test stage
Age
From 7 years old to 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
In this research, the subjects were selected in an accessible and purposeful way and according to the desired criteria and by simple randomization, using a table of random numbers, and randomization on the web and using coded boxes with a random sequence in the experimental group. and control will be divided.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The present research, after the implementation of 8 weeks of intervention (perceptual-motor exercises), in order to evaluate the durability of the interventions, after 2 months, the dependent variables will be evaluated again.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Islamic Azad University - Ahvaz Branch
Street address
Address: Khuzestan province, Ahvaz city, Golestan highway, Farhang Shahr, Islamic Azad University, Ahvaz branch, Faculty of Nursing and Midwifery
City
Ahvaz
Province
Khouzestan
Postal code
۶۱۳۴۹۳۷۳۳۳
Approval date
2022-04-13, 1401/01/24
Ethics committee reference number
IR.IAU.AHVAZ.REC.1401.054
Health conditions studied
1
Description of health condition studied
People with mental disabilities
ICD-10 code
F70
ICD-10 code description
Mild intellectual disabilities
Primary outcomes
1
Description
Learning movement skills
Timepoint
The measurement will be done in the pre-test stage and post-test stage.
Method of measurement
TGMD-3 test.
2
Description
Executive functions
Timepoint
The measurement will be done in the pre-test stage and post-test stage.
Method of measurement
Connors neuropsychological test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, children will participate in eight weeks of perceptual-motor exercises, which include stretching exercises, perceptual-motor exercises (including: identification of different directions, static balance and dynamic balance, coordinated movements and simultaneous movements of throwing the ball at the target, receiving and passing the ball, targeted movements, throwing darts will be safe...) and training will be back to the original state. The exercises will be performed by the trainer and the children will coordinate their movements with the trainer and the group.
Category
Rehabilitation
2
Description
Control group: The subjects of the control group did not participate in the intervention after participating in the pre-test and only performed the daily routine program that was in accordance with the regular programs of the center.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Welfare center of Abdanan city, Ilam province
Full name of responsible person
Yones Anbari
Street address
Abdanan, Mustafa Khomeini Street, Imam Hossein Square
City
Abdanan
Province
Ilam
Postal code
6975117379
Phone
+98 84 3362 8270
Email
Farzad.Mohammadi59@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farzad Mohammadi
Street address
Department of Physical Education & Sport Science, Abadan Branch, Islamic Azad University, Abadan, Iran
City
Abadan
Province
Khouzestan
Postal code
۶۳۱۷۸۳۶۵۳۱
Phone
+98 61 5336 0112
Fax
+98 61 5336 0111
Email
Farzad.Mohammadi59@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Farzad Mohammadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Motor Development
Street address
Abadan branch, Islamic Azad University, in front of Taleghani Hospital,Nurse Square, Fieh, Station 12, Abadan.
City
Abadan
Province
Khouzestan
Postal code
۶۳۱۷۸۳۶۵۳۱
Phone
00986153360112-9
Email
Farzad.Mohammadi59@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farzad Mohammadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Motor Development
Street address
Abadan Branch, Islamic Azad University
City
Abadan
Province
Khouzestan
Postal code
۶۳۱۷۸۳۶۵۳۱
Phone
+98 61 5336 0112
Email
Farzad.Mohammadi59@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farzad Mohammadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Motor Development
Street address
Abadan Branch, Islamic Azad University
City
Abadan
Province
Khouzestan
Postal code
۶۳۱۷۸۳۶۵۳۱
Phone
+98 61 5336 0112
Email
Farzad.Mohammadi59@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
Only a part of the data, such as the information related to the main outcome or the like, can be shared after the completion of the project.
When the data will become available and for how long
The access period starts 9 months after the publication of the results and articles
To whom data/document is available
The data will be available to researchers.
Under which criteria data/document could be used
The detailed information of the study can be provided to competent researchers interested in the field of mental retardation.
From where data/document is obtainable
Correspond with farzad.mohammadi59@gmail.com .
What processes are involved for a request to access data/document
Competent and interested researchers can receive data documentation after publication of the work from the corresponding author by providing their academic information and identification.
Comments
This clinical trial with the title "Effect of eight weeks of perceptual motor training on executive functions and motor skill learning of mentally retarded children" has not been previously registered anywhere else and has not been submitted anywhere else at the same time. We are very happy to register our clinical trial with IRCT. thank you.