Protocol summary

Study aim
Assessing the impact of a perceptual-motor exercise program on the motor performance, social adaptation and self-efficacy of children with intellectual disabilities in Bukan city
Design
This is a single-blind, randomized clinical trial with a control group and parallel groups, involving 26 participants. Randomization will be conducted using the RAND function in Exce
Settings and conduct
After examination of several education centers for these children, in terms of the number of people, an exceptional school will be selected due to the large number of participants. Among the children of that primary school, children who meet the entry and exit criteria will be selected. Sample size will be determined 26 people from this community. These people will be randomly divided into two groups of perceptual-motor exercises and control. The present study will be conducted in the sports hall of the selected school Then the groups will be measured in the pre-test and after recording the scores of the pre-test, the perceptual-motor exercises group will be under the special exercises of their group and the control group will not be exposed to any intervention. The experimental group will participate in their exercise program for eight weeks, 3 sessions per week and each session is 45 minutes,
Participants/Inclusion and exclusion criteria
Inclusion criteria: Students with mild intellectual disability, age range between 10 and 12 years; Exclusion criteria: unwillingness to cooperate
Intervention groups
Group of perceptual-motor exercises:This group underwent underwent a training program spanning eight weeks, with three sessions per week, resulting in a total of 24 sessions. Each session lasted 45 minutes Control group: the control group followed their normal daily schedule.
Main outcome variables
motor performance, Social adjustment, self-efficacy

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190908044722N4
Registration date: 2024-02-26, 1402/12/07
Registration timing: registered_while_recruiting

Last update: 2024-02-26, 1402/12/07
Update count: 0
Registration date
2024-02-26, 1402/12/07
Registrant information
Name
Razieh Khanmohamadi
Name of organization / entity
The university of Urmia
Country
Iran (Islamic Republic of)
Phone
+98 86 3221 4311
Email address
r.khanmohamadi@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-21, 1402/11/01
Expected recruitment end date
2024-03-15, 1402/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Perceptual Motor Exercises on Motor Performance, Social Adaptation, and Self-Efficacy of Mentally Retarded Children in Bukan City
Public title
The Effect of Perceptual Motor Exercises on Motor Performance, Social Adaptation, and Self-Efficacy of Mentally Retarded Children in Bukan City
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
1- Diagnosis of mild intellectual disability (IQ 50-70) with the capacity for learning; ; 2- Age range of 10-12 years old 3- Completion of an informed consent form by parents for their children’s participation in research practice sessions;
Exclusion criteria:
Presence of specific conditions such as epilepsy, seizures, cerebral palsy, and impairments in vision, hearing, and heart function, among other specific diseases Concurrent participation in other clinical interventions during the research period Presence of significant psychiatric symptoms in the child, such as autism or attention deficit hyperactivity disorder
Age
From 10 years old to 12 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 26
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be randomly assigned to two groups: the perceptual-motor exercises group and the control group. The randomization process will be conducted using the RAND function in Excel
Blinding (investigator's opinion)
Single blinded
Blinding description
“Evaluations in this research will be conducted by an individual who is blind to the group assignments of the children
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Urmia University
Street address
Urmia University, Kilometer 11 of Cypress Road, Urmia, West Azarbaijan Province
City
Urmia
Province
West Azarbaijan
Postal code
5756151818
Approval date
2024-01-06, 1402/10/16
Ethics committee reference number
IR.URMIA.REC.1402.025

Health conditions studied

1

Description of health condition studied
Mental retardation
ICD-10 code
F70-F79
ICD-10 code description
Mental retardation

Primary outcomes

1

Description
Motor Performance
Timepoint
Before and after the intervention
Method of measurement
Test of Gross Motor Development

2

Description
Social Adaptation
Timepoint
Before and after the intervention
Method of measurement
. Adjustment Inventory Sinha and Sing

3

Description
Self-Efficacy
Timepoint
Before and after the intervention
Method of measurement
Wheeler and Weld children's self-efficacy scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Perceptual Motor Exercises The Intervention group underwent a training program spanning eight weeks, with three sessions per week, resulting in a total of 24 sessions. Each session lasted 45 minutes and was divided into three phases.The first phase, a 10-minute warm-up, incorporated stretching exercises targeting major muscle groups and joints, supplemented by slow-paced walking and jogging.The second phase, lasting 30 minutes, was dedicated to motor perception exercises. The exercise protocol implemented during this phase was adapted from the protocol established by Jafari et al. (1400).The final phase, a 5-minute cool-down, aimed to return the body to its initial state. This phase included light stretching exercises, slow walking, and deep breathing.
Category
Rehabilitation

2

Description
Control group: During this period, the control group did not have any perceptual motor training program and followed their normal daily schedule.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Lale Primary School
Full name of responsible person
Razieh Khanmohammadi
Street address
Urmia University, Kilometer 11 of Cypress Road, Urmia, West Azarbaijan Province
City
Urmia
Province
West Azarbaijan
Postal code
5756151818
Phone
+98 918 624 2003
Email
r.khanmohamadi65@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The university of urmia
Full name of responsible person
Razieh Khanmohammadi
Street address
Urmia University, Kilometer 11 of Cypress Road, Urmia, West Azarbaijan Province
City
Urmia
Province
West Azarbaijan
Postal code
5756151818
Phone
+98 918 624 2003
Email
r.khanmohamadi@urmia.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The university of urmia
Proportion provided by this source
1
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
The university of urmia
Full name of responsible person
Razieh Khanmohammadi
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
motor behavior
Street address
Urmia University, Kilometer 11 of Cypress Road, Urmia, West Azarbaijan Province
City
Urmia
Province
West Azarbaijan
Postal code
5756151818
Phone
43-32752741-044
Email
r.khanmoamadi65@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
The university of urmia
Full name of responsible person
Razieh Khanmohammadi
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
motor behavior
Street address
Urmia University, Kilometer 11 of Cypress Road, Urmia, West Azarbaijan Province
City
Urmia
Province
West Azarbaijan
Postal code
5756151818
Phone
43-32752741-044
Email
r.kanmohamadi65@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
The university of urmia
Full name of responsible person
Razieh Khanmohammadi
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
motor behavior
Street address
Urmia University, Kilometer 11 of Cypress Road, Urmia, West Azarbaijan Province
City
Urmia
Province
West Azarbaijan
Postal code
5756151818
Phone
43-32752741-044
Email
r.khanmohamadi65@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
It is mentioned in the consent form that the information remains with the researcher
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The analysis of information obtained from the results of the interventions on motor performance can be published
When the data will become available and for how long
From the time the article was published until a year later
To whom data/document is available
All researchers
Under which criteria data/document could be used
Provided Someone wants to do a similar research project
From where data/document is obtainable
r.khanmohamadi65@yahoo.com
What processes are involved for a request to access data/document
Sending requests via email, review by the author and contacting him and providing requested items
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