Protocol summary

Study aim
The purpose of this research is to investigate the effect of square stepping exercises on motor factors (static balance, dynamic balance) and cognitive factors (executive functions, working memory, alternating attention and sustained attention).
Design
This plan has two intervention and control groups. A blind side and a parallel group were divided into two groups non-randomly. on 28 high-functioning autistic children
Settings and conduct
autistic children in two exceptional schools in Tehran will be invited to cooperate . After the agreement, the consent form will be provided to the parents. the relevant tests will be taken from the control and intervention groups, and after that, 8 weeks of square stepping exercises will be performed on the intervention group, tests will be taken from the control and intervention groups to determine the effectiveness of the research
Participants/Inclusion and exclusion criteria
1) Diagnosis of autism disorder by a child psychiatrist 2) completion of Gilliam Garez 2 questionnaire by parents 3) Children in the age range of 7-12 years should be boys with high performance 4) Do not have a physical disorder such as cerebral palsy 5) Completion of the consent form to participate in the study by the child's parents 6) The child should be able to do exercises 7) Being diagnosed with autism before the age of 3
Intervention groups
Stepping-Square exercise It includes various movements in different directions, which will be performed on a 100 x 250 cm screen, which is divided into 40 25 cm squares, and there are a total of 196 walking patterns of different degrees. Trainings are held for 8 weeks and 3 sessions per week
Main outcome variables
Dynamic balance - Static balance - Executive functions - Active memory - Sustained attention - Intermittent attention

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240712062404N1
Registration date: 2024-07-30, 1403/05/09
Registration timing: registered_while_recruiting

Last update: 2024-07-30, 1403/05/09
Update count: 0
Registration date
2024-07-30, 1403/05/09
Registrant information
Name
Setayesh Zarifnia
Name of organization / entity
Shahid beheshti university
Country
Iran (Islamic Republic of)
Phone
+98 21 4466 4315
Email address
s.zarifnia@mail.sbu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-15, 1403/04/25
Expected recruitment end date
2024-09-15, 1403/06/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the effect of 8 weeks of square stepping exercise on the motor and cognitive factors of autism spectrum children
Public title
the effect of square stepping exercise on the motor and cognitive factors of autism spectrum children
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of autism disorder by a child psychiatrist Completion of Gilliam Gars 2 questionnaire by parents Children in the age range of 7-12 years should be boys with high performance Completion of the consent form to participate in the study by the child's parents The child is able to do exercises Score 18 to 25 in BMI test Diagnosing autism in these children before the age of 3
Exclusion criteria:
having obvious musculoskeletal abnormalities in the lower limbs suffering from a specific disease that prohibits sports activity (confirmation from a specialist doctor Do have a physical disorder such as cerebral palsy Do have disorders associated with autism such as Down syndrome (confirmed by an expert psychologist)
Age
From 7 years old to 12 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 28
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
In the present study, the participants are unaware of the specialization of the group, because these autistic children are 7 to 12 years old, they will participate in this research with the consent of their parents, so they do not know the specialization of the groups. It will not explain to these autistic children (participants).
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University
Street address
Quds town (West), between South Flamek and Zarafshan, Simai Iran St., Central Headquarters of the Ministry of Health, Treatment and Medical Education, Block A,
City
tehran
Province
Tehran
Postal code
1394613765
Approval date
2024-04-20, 1403/02/01
Ethics committee reference number
IR.SBU.REC.1403.053

Health conditions studied

1

Description of health condition studied
Autism
ICD-10 code
F84.0
ICD-10 code description
Autistic disorder

Primary outcomes

1

Description
Static balance
Timepoint
Measurement of variables after 8 weeks of square stepping exercises
Method of measurement
Stork walking test

2

Description
Dynamic balance
Timepoint
Measurement of variables after 8 weeks of square stepping exercises
Method of measurement
Heel toe walking test

3

Description
Executive functions
Timepoint
Measurement of variables after 8 weeks of square stepping exercises
Method of measurement
Brief questionnaire

4

Description
Working memory
Timepoint
Measurement of variables after 8 weeks of square stepping exercises
Method of measurement
Corsi blocks test

5

Description
Sustained attention
Timepoint
Measurement of variables after 8 weeks of square stepping exercises
Method of measurement
continuous performance test

6

Description
Alternating attention
Timepoint
Measurement of variables after 8 weeks of square stepping exercises
Method of measurement
Wisconsin test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 14 autistic children of 8 weeks (three sessions per week) perform square stepping exercises for 30 minutes each session. The exact shape and framework of square stepping exercises will be drawn on the ground with colored glue and the exercises will proceed based on the patterns of these exercises. First, the researcher explains the pattern of stepping and then asks the child to do the pattern. According to the studies, this treatment method has a positive effect on the motor and cognitive factors of these children.
Category
Other

2

Description
Control group : The control group will not receive any intervention and only the pre-test and post-test will be taken from the control group
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
An Exceptional School Of Affection
Full name of responsible person
Fahimeh Mosavi Nezhad
Street address
Saadat Abad
City
Tehran
Province
Tehran
Postal code
1394613765
Phone
+98 21 8868 4773
Email
setayeshzr.1379@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyed Mohammad Hosseini
Street address
Tehran
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2243 1607
Email
pr-office@sbu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
5
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Setayesh Zarifnia
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Pediatrics
Street address
Tehran.Ekbatan.Faze1.Block A5
City
Tehran
Province
Tehran
Postal code
1394613765
Phone
+98 21 4466 4315
Email
setayeshzr.1379@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Setayesh Zarifnia
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Pediatrics
Street address
Tehran.Ekbatan.Faze1.Block A5
City
Tehran
Province
Tehran
Postal code
1394613765
Phone
+98 21 4466 4315
Email
setayshzr.1379@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Setayesh Zarifnia
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Pediatrics
Street address
Tehran.Ekbatan.Faze1.Block A5
City
Tehran
Province
Tehran
Postal code
1394613765
Phone
+98 21 4466 4315
Email
setayeshzr.1379@yahoo.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
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The decision to publish the data has not yet been made
When the data will become available and for how long
The decision to publish the data has not yet been made
To whom data/document is available
The decision to publish the data has not yet been made
Under which criteria data/document could be used
The decision to publish the data has not yet been made
From where data/document is obtainable
The decision to publish the data has not yet been made
What processes are involved for a request to access data/document
The decision to publish the data has not yet been made
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