Determining the effect of vestibular exercises and motor coordination on the cognitive functions of autistic children
Design
Clinical trial with control group, with parallel groups, unblinded, randomized, on 30 patients. for randomization used lottery method.
Settings and conduct
In this research, will be sampled 30 children age between 6 to 15 years with autism spectrum disorder level one from autism center and Besharat and Omidanejat schools in Semnan city, and will be randomly divided into 3 groups: vestibular exercises, motor coordination exercises and control group.
they do exercises for 8 weeks and three sessions each week and each session lasts for one hour.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Informed parental consent
The gender of boys and girls
Autism with level 1
Age between 6 and 15 years
Exclusion criteria:
Attend other therapy sessions
Intervention groups
The intervention group includes two groups of vestibular and motor coordination exercises.
The control group received no intervention.
Main outcome variables
Cognitive function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240603061993N1
Registration date:2024-07-31, 1403/05/10
Registration timing:retrospective
Last update:2024-07-31, 1403/05/10
Update count:0
Registration date
2024-07-31, 1403/05/10
Registrant information
Name
mona gorji
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3333 6678
Email address
mona.grj5144@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-20, 1403/02/01
Expected recruitment end date
2024-04-29, 1403/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of vestibular and motor coordination on cognitive function in children with autism spectrum disorder
Public title
The impact of vestibular and motor coordination on cognitive function in children with autism spectrum disorder
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Informed parental consent
The gender of boys and girls
Autism with level 1
Age between 6 and 15 years
Exclusion criteria:
Age
From 6 years old to 15 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 simple random sampling, the selection of participants is completely based on chance and probability. Each participant has an equal chance of entering the sample. The randomization method is done by lottery. In this way, one number is given to each person. Numbers are randomly taken from the container and placed in three groups. Therefore, one group is randomly selected as the "control group" and the other two groups as the "intervention group". In this way, to randomly determine the "control group" and "intervention group", we put the list of each group in three separate envelopes and put them in a container. Then we randomly take one envelope from the container and assign it to the "control group" and then the second and third group of envelopes are assigned to the "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
Research Ethics Committee of Islamic Azad University - Semnan branch
Street address
Kilometer 5 of Semnan-Damghan road,
City
Semnan
Province
Semnan
Postal code
۳۷۱۱۱۳۵۱۳۱
Approval date
2024-05-21, 1403/03/01
Ethics committee reference number
IR.IAU.SEMNAN.REC.1403.023
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
Cognitive function
Timepoint
The cognitive function of the clients is measured before and after the intervention of vestibular exercises and motor coordination.
Method of measurement
Cognitive-diagnostic test kay
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:The vestibular training group consists of 10 people who receive vestibular training for 8 weeks.
Category
Rehabilitation
2
Description
Intervention group: The motor coordination training group which includes 10 people who receive motor coordination training for 8 weeks.
Category
Rehabilitation
3
Description
Control group: This group includes 10 people who do not receive any intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Zehn ziba Autism Center
Full name of responsible person
Mona gorji
Street address
No. 27, East12 Taavon Ave., Modares Blv
City
Semnan
Province
Semnan
Postal code
3514847940
Phone
+98 23 3344 8330
Email
mona.grj5144@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Shahab Moradi
Street address
Kilometer 5 of Semnan-Damghan road
City
Semnan
Province
Semnan
Postal code
۳۷۱۱۱۳۵۱۳۱
Phone
+98 23 3333 7866
Email
mona.grj5144@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
Mona Gorji
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 8, Saadi Ave., Saadi7
City
Semnan
Province
Semnan
Postal code
3518694793
Phone
+98 23 3333 7866
Email
mona.grj5144@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mona Gorji
Position
studdent
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 8, Saadi Ave., Sadi 7
City
Semnan
Province
Semnan
Postal code
3518694793
Phone
+98 23 3333 7866
Email
mona.grj5144@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
mona gorji
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 8, Saadi Ave., Saadi7
City
Semnan
Province
Semnan
Postal code
3518694793
Phone
023337866
Email
mona.grj5144@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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is 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
Title and more details about the data/document
Results and data can be shared after de-identifying individuals.
When the data will become available and for how long
It is possible to access the data after the thesis and article are published.
What processes are involved for a request to access data/document
The applicant must explain the topic, statistical sample and working method in the email and after checking it will be available to the applicant within one to two days.