Investigating the Effectiveness of Physical Activities on Balance, Cognition, and Performing Dual Tasks among Children with Autism Spectrum Disorder: A Double-Blind Randomized Clinical Trial
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Protocol summary
After receiving the code of ethics, students of the centers and schools of Shiraz City will be screened to check the inclusion criteria and eligible children; After obtaining written consent from the parents, they will undergo initial evaluation and be randomly divided into two experimental and control groups. Before the implementation of the intervention, children's balance, cognitive and dual-task performance are measured by a co-evaluator who does not know which group the participants belong to. The intervention group received a 24-session occupational therapy program, and the control group received routine interventions. After completing the occupational therapy program, the variables will be re-evaluated
After receiving the code of ethics, students of the centers and schools of Tehran City will be screened to check the inclusion criteria and eligible children; After obtaining written consent from the parents, they will undergo initial evaluation and be randomly divided into two experimental and control groups. Before the implementation of the intervention, children's balance, cognitive and dual-task performance are measured by a co-evaluator who does not know which group the participants belong to. The intervention group received a 24-session occupational therapy program, and the control group received routine interventions. After completing the occupational therapy program, the variables will be re-evaluated
After receiving the code of ethics, students of the centers and schools of ShirazTehran City will be screened to check the inclusion criteria and eligible children; After obtaining written consent from the parents, they will undergo initial evaluation and be randomly divided into two experimental and control groups. Before the implementation of the intervention, children's balance, cognitive and dual-task performance are measured by a co-evaluator who does not know which group the participants belong to. The intervention group received a 24-session occupational therapy program, and the control group received routine interventions. After completing the occupational therapy program, the variables will be re-evaluated
پس از دریافت کد اخلاق، مراجعین مراکز و مدارس شهر شیراز برای بررسی معیارهای ورود، مورد غربالگری قرار خواهند گرفت و کودکان واجد شرایط؛ پس از اخذ رضایت کتبی از والدین مورد ارزیابی اولیه قرار خواهند گرفت و به صورت تصادفی در دو گروه تجربی و کنترل قرار می گیرند. قبل از اجرای مداخله عملکرد تعادلی، شناختی و توانایی انجام تکلیف دو گانه کودکان توسط یک ارزیاب همکار که نمی داند شرکت کنندگان به کدام گروه تعلق دارند، سنجیده می شوند. گروه مداخله برنامه کاردرمانی ۲۴ جلسه ای را دریافت می کنند و گروه کنترل مداخلات روتین را دریافت می کنند.پس از اتمام برنامه کاردرمانی متغیر ها مجدد مورد ارزیابی قرار خواهند گرفت.
پس از دریافت کد اخلاق، مراجعین مراکز و مدارس شهر تهران برای بررسی معیارهای ورود، مورد غربالگری قرار خواهند گرفت و کودکان واجد شرایط؛ پس از اخذ رضایت کتبی از والدین مورد ارزیابی اولیه قرار خواهند گرفت و به صورت تصادفی در دو گروه تجربی و کنترل قرار می گیرند. قبل از اجرای مداخله عملکرد تعادلی، شناختی و توانایی انجام تکلیف دو گانه کودکان توسط یک ارزیاب همکار که نمی داند شرکت کنندگان به کدام گروه تعلق دارند، سنجیده می شوند. گروه مداخله برنامه کاردرمانی ۲۴ جلسه ای را دریافت می کنند و گروه کنترل مداخلات روتین را دریافت می کنند.پس از اتمام برنامه کاردرمانی متغیر ها مجدد مورد ارزیابی قرار خواهند گرفت.
پس از دریافت کد اخلاق، مراجعین مراکز و مدارس شهر شیرازتهران برای بررسی معیارهای ورود، مورد غربالگری قرار خواهند گرفت و کودکان واجد شرایط؛ پس از اخذ رضایت کتبی از والدین مورد ارزیابی اولیه قرار خواهند گرفت و به صورت تصادفی در دو گروه تجربی و کنترل قرار می گیرند. قبل از اجرای مداخله عملکرد تعادلی، شناختی و توانایی انجام تکلیف دو گانه کودکان توسط یک ارزیاب همکار که نمی داند شرکت کنندگان به کدام گروه تعلق دارند، سنجیده می شوند. گروه مداخله برنامه کاردرمانی ۲۴ جلسه ای را دریافت می کنند و گروه کنترل مداخلات روتین را دریافت می کنند.پس از اتمام برنامه کاردرمانی متغیر ها مجدد مورد ارزیابی قرار خواهند گرفت.
General information
empty
Due to the insufficient number of samples and the lack of access to some assessment tools in Shiraz city, the location of the study was changed to Tehran city.
Due to the insufficient number of samples and the lack of access to some assessment tools in Shiraz city, the location of the study was changed to Tehran city.
empty
با توجه به کافی نبودن تعداد نمونه ها و عدم دسترسی به برخی ابزار ارزیابی در شهر شیراز محل انجام مطالعه به شهر تهران تغییر یافت.
با توجه به کافی نبودن تعداد نمونه ها و عدم دسترسی به برخی ابزار ارزیابی در شهر شیراز محل انجام مطالعه به شهر تهران تغییر یافت.
Recruitment centers
#1
Name of recruitment center - English: Exceptional school of Farazdaghi
Name of recruitment center - Persian: مدرسه استثنایی فرزدقی
Full name of responsible person - English: Saeed Tavangar
Full name of responsible person - Persian: سعید توانگر
Street address - English: 19th Alley, Shahidan Farzadeghi Street, Amir Kabir, Shiraz, Fars
Street address - Persian: فارس، شیراز، امیر کبیر، خ شهیدان فرزدقی، کوچه 19
City - English: تهران
City - Persian: تهران
Province: Fars
Country: Iran (Islamic Republic of)
Postal code: 7176818367
Phone: +98 71 3822 9608
Fax:
Email: minhashempour@gmail.com
Web page address:
Name of recruitment center - English: Exceptional school of Payambar Azam
Name of recruitment center - Persian: مدرسه استثنایی پیامبر اعظم
Full name of responsible person - English: Mohammad Beheshti pour
Full name of responsible person - Persian: محمد بهشتی پور
Street address - English: No.6, Kohsar Alley, Imam Hossein st., Satari bridge, Hemmat highway
Street address - Persian: اتوبان همت، پل ستاری، خیابان امام حسین،کوچه کوهسار،پلاک 6
City - English: تهران
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1476918386
Phone: +98 21 4446 6527
Fax:
Email: nikookari.kazemi@gmail.com
Web page address:
Name of recruitment center - English: Exceptional school of FarazdaghiPayambar Azam Name of recruitment center - Persian: مدرسه استثنایی فرزدقیپیامبر اعظم Full name of responsible person - English: Saeed TavangarMohammad Beheshti pour Full name of responsible person - Persian: سعید توانگرمحمد بهشتی پور Street address - English: 19thNo.6, Kohsar Alley, Shahidan Farzadeghi StreetImam Hossein st., Amir KabirSatari bridge, Shiraz, FarsHemmat highway Street address - Persian: فارساتوبان همت، شیرازپل ستاری، امیر کبیرخیابان امام حسین، خ شهیدان فرزدقی، کوچه 19کوهسار،پلاک 6 City - English: تهران City - Persian: تهران Province: FarsTehran Country: Iran (Islamic Republic of) Postal code: 71768183671476918386 Phone: +98 71 3822 960821 4446 6527 Fax: Email: minhashempournikookari.kazemi@gmail.com Web page address:
#2
Name of recruitment center - English: Exceptional school of Exir
Name of recruitment center - Persian: مدرسه استثنایی اکسیر
Full name of responsible person - English: Sajede Moradi
Full name of responsible person - Persian: ساجده مرادی
Street address - English: No. 37, corner of 16 Sanatgar St, South Bahonar, Bahonar Crossroads
Street address - Persian: چهارراه با هنر، با هنر جنوبی، نبش کوچه 16 خیابان صنعتگر، پلاک37
City - English: Shiraz
City - Persian: شیراز
Province: Fars
Country: Iran (Islamic Republic of)
Postal code: 7176895648
Phone: +98 71 3822 4359
Fax:
Email: aminmanshadi1375@gmail.com
Web page address:
Name of recruitment center - English: Exceptional school of Torab
Name of recruitment center - Persian: مدرسه استثنایی تراب
Full name of responsible person - English: Elham Pourhasan
Full name of responsible person - Persian: الهام پورحسن
Street address - English: Shahid Akhlaghi Alley, Qanat Crossroads, Dolat St.
Street address - Persian: خیابان دولت، چهارراه قنات، کوچه شهید اخلاقی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1939793453
Phone: +98 21 2255 8487
Fax:
Email: E.dehghan@gmail.com
Web page address:
Name of recruitment center - English: Exceptional school of ExirTorab Name of recruitment center - Persian: مدرسه استثنایی اکسیرتراب Full name of responsible person - English: Sajede MoradiElham Pourhasan Full name of responsible person - Persian: ساجده مرادیالهام پورحسن Street address - English: No. 37Shahid Akhlaghi Alley, corner of 16 SanatgarQanat Crossroads, Dolat St, South Bahonar, Bahonar Crossroads. Street address - Persian: خیابان دولت، چهارراه با هنرقنات، با هنر جنوبی، نبش کوچه 16 خیابان صنعتگر، پلاک37شهید اخلاقی City - English: ShirazTehran City - Persian: شیرازتهران Province: FarsTehran Country: Iran (Islamic Republic of) Postal code: 71768956481939793453 Phone: +98 71 3822 435921 2255 8487 Fax: Email: aminmanshadi1375E.dehghan@gmail.com Web page address:
#3
Name of recruitment center - English: Exceptional school of Angizeh
Name of recruitment center - Persian: مدرسه استثنایی انگیزه
Full name of responsible person - English: Zohre Hosseini
Full name of responsible person - Persian: زهره حسینی
Street address - English: 5th Alley, 1st Nastaran Ave., Moali Abad
Street address - Persian: معالی آباد، خیابان نسترن یکم، کوچه ی پنجم
City - English: Shiraz
City - Persian: شیراز
Province: Fars
Country: Iran (Islamic Republic of)
Postal code: 7175857461
Phone: +98 71 3639 2795
Fax:
Email: masouri_m@yahoo.com
Web page address:
Name of recruitment center - English: Exceptional school of Fereshtegan Asemani
Name of recruitment center - Persian: مدرسه استثنایی فرشتگان آسمانی
Full name of responsible person - English: Ali Hosseini
Full name of responsible person - Persian: علی حسینی
Street address - English: No. 68, 17th St., Jalal Al Ahmad St., Gisha
Street address - Persian: گیشا، خیابان جلال آل احمد، خیابان هفدهم، پلاک 68
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1447733511
Phone: +98 21 8827 4864
Fax:
Email: nazi.tarafdari12@gmail.com
Web page address:
Name of recruitment center - English: Exceptional school of AngizehFereshtegan Asemani Name of recruitment center - Persian: مدرسه استثنایی انگیزهفرشتگان آسمانی Full name of responsible person - English: ZohreAli Hosseini Full name of responsible person - Persian: زهرهعلی حسینی Street address - English: 5th AlleyNo. 68, 1st Nastaran Ave17th St., Moali AbadJalal Al Ahmad St., Gisha Street address - Persian: معالی آبادگیشا، خیابان نسترن یکمجلال آل احمد، کوچه ی پنجمخیابان هفدهم، پلاک 68 City - English: ShirazTehran City - Persian: شیرازتهران Province: FarsTehran Country: Iran (Islamic Republic of) Postal code: 71758574611447733511 Phone: +98 71 3639 279521 8827 4864 Fax: Email: masouri_mnazi.tarafdari12@yahoo.comgmail.com Web page address:
Protocol summary
Study aim
Investigating the effectiveness of physical exercises on balance, cognition, and dual-task performance in 6-12 years old children with Autism Spectrum Disorder
Design
Double-blinded Randomized controlled trial of 30 patients; randomization will be via block randomization.
Settings and conduct
After receiving the code of ethics, students of the centers and schools of Tehran City will be screened to check the inclusion criteria and eligible children; After obtaining written consent from the parents, they will undergo initial evaluation and be randomly divided into two experimental and control groups. Before the implementation of the intervention, children's balance, cognitive and dual-task performance are measured by a co-evaluator who does not know which group the participants belong to. The intervention group received a 24-session occupational therapy program, and the control group received routine interventions. After completing the occupational therapy program, the variables will be re-evaluated
Participants/Inclusion and exclusion criteria
Inclusion criteria include diagnosis of high-functioning autism; obtaining a score of 55-70 in the GARS-3 questionnaire; age 6-12 years old. Exclusion criteria: using aids such as canes to maintain balance; or take medications that affect balance.
Intervention groups
Participants in the intervention group will participate in a 24-session 45-minute occupational therapy program. This program includes several categories of physical activities to improve agility, balance, central stability, and motor coordination. In this program, with the increase in the number of treatment sessions, the difficulty level of the exercises will increase.
Participants in the control group receive routine rehabilitation interventions.
Main outcome variables
Balance; cognition; the ability to do cognitive-motor dual-tasks
General information
Reason for update
Due to the insufficient number of samples and the lack of access to some assessment tools in Shiraz city, the location of the study was changed to Tehran city.
Acronym
IRCT registration information
IRCT registration number:IRCT20221214056817N1
Registration date:2023-05-12, 1402/02/22
Registration timing:prospective
Last update:2024-02-26, 1402/12/07
Update count:1
Registration date
2023-05-12, 1402/02/22
Registrant information
Name
Mina Hashempour Alooche
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4425 2633
Email address
minhashempour@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-15, 1402/02/25
Expected recruitment end date
2023-11-16, 1402/08/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effectiveness of Physical Activities on Balance, Cognition, and Performing Dual Tasks among Children with Autism Spectrum Disorder: A Double-Blind Randomized Clinical Trial
Public title
Investigating the effectiveness of physical activities on motor and cognitive skills in children with autism
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Child psychiatrists diagnose high-functioning Autism Spectrum Disorder
Using the Gilliam Autism Rating Scale - Third Edition (GARS 3) to diagnose level 1 Autism Spectrum Disorder
The students study in normal schools or special autism spectrum disorders schools
Participants are between the ages of 6 and 12
Exclusion criteria:
Maintaining balance or walking with aids
Using balance-affecting drugs
Being visually and audibly impaired
Having comorbidities of autism spectrum disorders with psychological disorders such as attention deficit hyperactivity disorder, obsessive compulsive disorder, etc.
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Children aged 6-12 with high-functioning autism were included in the study using accessible sampling. Then the stratified randomization method will be used, and the samples will be classified based on age and body mass index. The stratified randomization method eliminates the need to control the influence of background variables. In this method, we create a separate block for each combination of contextual variables, and subjects are assigned to a suitable block of contextual variables. After all the subjects have been identified and divided into blocks, they are placed in groups that have equal sample size through the block randomization method, and considering all possible balanced combinations of assignment in the block and random selection of one of these situations are assigned to one of the experimental or control groups through a lottery for each block of people.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, each person is assigned a number, and they are randomly placed in the experimental or control groups, then the researcher performs the therapeutic intervention on the group without knowing about their attribution; The evaluator is also another colleague who is also unaware of how people are allocated; data evaluation will also be done by someone other than the research team.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Building No. 2, Shahid Beheshti University of Medical Sciences, Arabi St., Daneshjou Blvd., Valenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2022-12-04, 1401/09/13
Ethics committee reference number
IR.SBMU.RETECH.REC.1401.567
Health conditions studied
1
Description of health condition studied
Autism Spectrum Disorder
ICD-10 code
F84.0
ICD-10 code description
Autistic disorder
Primary outcomes
1
Description
Static and dynamic balance
Timepoint
Measurement of a static and dynamic balance of the samples before the start of the intervention and eight weeks after the beginning of the intervention in the test group.
Method of measurement
Using the Walking Heel to Toe test to evaluate dynamic balance and using the Force Plate device to assess static balance.
2
Description
Cognitive functions
Timepoint
Measuring the cognitive functions of the samples before the start of the intervention and eight weeks after the beginning of the intervention in the test group.
Method of measurement
Wisconsin card sorting tests, forward and backward digit span test, and executive function behavioral rating questionnaires will be used to evaluate cognitive indicators.
3
Description
Ability to perform dual tasks
Timepoint
Measuring the ability to perform dual tasks of the samples before the start of the intervention and eight weeks after the beginning of the intervention in the test group.
Method of measurement
The person performs balance tests, including the Walking Heel Toe Test and standing on the Force Plate device simultaneously with the Forward Digit Span Test.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group will participate in a 45-minute exercise program. This program includes several categories of physical exercises to improve agility, balance, central stability, and motor coordination. Among the different parts of this program, we can mention jumping, walking on different surfaces, balancing activities in various positions, exercises aimed at improving central stability and bilateral coordination, eye-hand coordination, and eye-foot coordination. In this program, with the increase in the number of therapy sessions, the exercises' difficulty level will increase. It is worth noting that the intervention is conducted by an occupational therapist with experience working with children with an autism spectrum disorder in the form of 45-minute individual sessions three times a week for eight weeks.
Category
Rehabilitation
2
Description
Control group: receive routine rehabilitation program.
Shahid Akhlaghi Alley, Qanat Crossroads, Dolat St.
City
Tehran
Province
Tehran
Postal code
1939793453
Phone
+98 21 2255 8487
Email
E.dehghan@gmail.com
3
Recruitment center
Name of recruitment center
Exceptional school of Fereshtegan Asemani
Full name of responsible person
Ali Hosseini
Street address
No. 68, 17th St., Jalal Al Ahmad St., Gisha
City
Tehran
Province
Tehran
Postal code
1447733511
Phone
+98 21 8827 4864
Email
nazi.tarafdari12@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Building No. 2, Shahid Beheshti University of Medical Sciences, Arabi St., Daneshjou Blvd., Valenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9780
Email
info@sbmu.ac.ir
Web page address
https://research.sbmu.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
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ali Asghar Jamebozorgi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
Rehabilitation Science School Of Shahid Beheshti University of Medical Sciences, Damavand Ave., Imam Hossein Square
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7756 1721
Email
aas.bozorg@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ali Asghar Jamebozorgi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
Rehabilitation Science School Of Shahid Beheshti University of Medical Sciences, Damavand Ave., Imam Hossein Square
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7756 1721
Email
aas.bozorg@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mina Hashempour Alooche
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
Rehabilitation Science School Of Shahid Beheshti University of Medical Sciences, Damavand Ave., Imam Hossein Square
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7756 1721
Email
minhashempour@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
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
information on the primary and secondary outcome measures
When the data will become available and for how long
After publishing the articles
To whom data/document is available
Researchers in this field
Under which criteria data/document could be used
1. Written permissions from the research team
2. Mention the source of information
From where data/document is obtainable
Mina Hashempour Alooche
E-mail: minhashempour@gmail.com
address:Rehabilitation Science School Of Shahid Beheshti University of Medical Sciences, Damavand Ave., Imam Hossein Square, Tehran
What processes are involved for a request to access data/document
After sending the email to the researcher and requesting the document, the researcher will obtain the opinion of other members of the research team regarding the provision of this information and, if the members agree, the documents will be sent as soon as possible but sending the documents requires the acceptance of the criteria mentioned above.