Protocol summary

Study aim
Improvement the stereotypical behavior, sleep habits and balance of children with autism spectrum disorder with aquatic and karate exercise
Design
30 children aged 8-14 years with autism spectrum disorder were selected using available sampling method. They will randomly divided into two intervention groups and one control group.
Settings and conduct
Aquatic exercise intervention will be carried out in the welfare pool of the city of Rasht. Karate training intervention will be held at Ansar karate Club.
Participants/Inclusion and exclusion criteria
age (8 to 14) sex (male) having autism spectrum disorder not having co-morbid disability
Intervention groups
first intervention group: aquatic exercise second intervention group: karate training control group
Main outcome variables
Stereotypical behaviors; sleep habits; balance

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180626040242N1
Registration date: 2018-07-31, 1397/05/09
Registration timing: retrospective

Last update: 2018-07-31, 1397/05/09
Update count: 0
Registration date
2018-07-31, 1397/05/09
Registrant information
Name
Fahimeh Adibsaber
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3375 2906
Email address
adibsaber@iaurasht.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-30, 1396/11/10
Expected recruitment end date
2018-02-19, 1396/11/30
Actual recruitment start date
2018-01-30, 1396/11/10
Actual recruitment end date
2018-04-09, 1397/01/20
Trial completion date
empty
Scientific title
Comparison of the effect of aquatic and karate training on stereotypical behaviors, sleep habits and balance in children with Autism spectrum disorder
Public title
Comparison of the effect of aquatic and karate training on stereotypical behaviors, sleep habits and balance in children with Autism spectrum disorder
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
age (8 to 14 years old) sex (male) not having co-morbid disability parents consent
Exclusion criteria:
Receiving specialized treatment in addition to the usual treatment during study
Age
From 8 years old to 14 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Actual sample size reached: 30
Randomization (investigator's opinion)
Randomized
Randomization description
through drawing (The participants' names were written on paper and selected through simple random draw for the two intervention groups and a control group)
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
Medical Sciences Division-Research Ethics Committee
Street address
Azad University of Rasht, Lakan Boulevard
City
Rasht
Province
Guilan
Postal code
۴۱۴۷۶۵۴۹۱۹
Approval date
2017-09-19, 1396/06/28
Ethics committee reference number
IR.IAU.RASHT.REC.1396.131

Health conditions studied

1

Description of health condition studied
Autism Spectrum Disorder
ICD-10 code
F84.0
ICD-10 code description
Childhood autism

Primary outcomes

1

Description
stereotypical behaviors
Timepoint
A week before and after 10 weeks of intervention
Method of measurement
Gars-2 stereotypical behaviors subscale

2

Description
sleep habits
Timepoint
A week before and after 10 weeks of intervention
Method of measurement
Children’s Sleep Habits Questionnaire

3

Description
Balance
Timepoint
A week before and after 10 weeks of intervention
Method of measurement
Stabliometer

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: aquatic exercise (10 weeks, two session per week, 60 minutes including, 5 minutes warm up, 20 minutes aerobic exercise, 20 minutes strength training, 10 minutes free swimming and 5 minutes cool down)
Category
Treatment - Other

2

Description
Intervention group: Karate training (10 weeks, two session per week, 60 minutes each session, including 10 minutes warm up, 45 minutes of kata technique training and 5 minutes of cool down).
Category
Treatment - Other

3

Description
Control group: without training
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Guilan Autism Association
Full name of responsible person
Mehdi Zahedi Kalashtari
Street address
second Fooladloo, Saffari Ave, Bisoton Ave
City
Rasht
Province
Guilan
Postal code
4193191933
Phone
+98 13 3351 3235
Email
Z_hoj@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Masoomeh Shojaei
Street address
Islamic Azad university of Science and Research Branch, Shohadaye Hesarak Boulevard, University Square, the end of Ashrafi Esfahani Highway
City
Tehran
Province
Tehran
Postal code
۱۴۷۷۸۹۳۸۵۵
Phone
+98 44 8651 7982
Email
e5shojaei@yahoo.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
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fahimeh Adibsaber
Position
a faculty member
Latest degree
Master
Other areas of specialty/work
Others
Street address
Azad university of Rasht, Lakan Boulevard
City
Rasht
Province
Guilan
Postal code
۴۱۴۷۶۵۴۹۱۹
Phone
+98 13334221534
Email
adibsaber@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fahimeh Adibsaber
Position
a faculty member
Latest degree
Master
Other areas of specialty/work
Others
Street address
Azad university of Rasht, Lakan Boulevard
City
Rasht
Province
Guilan
Postal code
۴۱۴۷۶۵۴۹۱۹
Phone
+98 13334221534
Email
adibsaber@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fahimeh Adibsaber
Position
a faculty member
Latest degree
Master
Other areas of specialty/work
Others
Street address
Azad university of Rasht, Lakan Blv
City
Rasht
Province
Guilan
Postal code
۴۱۴۷۶۵۴۹۱۹
Phone
+98 13334221534
Email
adibsaber@gmail.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
Consulting and coordination with the supervisor
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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