Protocol summary

Study aim
Evaluation of predictive control of movement in children aged 8 to 13 years old with high functioning autism spectrum disorder and the effectiveness of motor imagery training on motor skills learning
Design
Clinical trial with a control group based on community with a parallel group
Settings and conduct
After the selection and entry of the participants in the private center for rehabilitation of autism, pre-intervention tests are carried out using penalty of basketball and movement assessment battery for children and training present at the center particularly. After 5 sessions of training then tests such as pre-test conditions at the Same center are done.
Participants/Inclusion and exclusion criteria
Inclusion criteria: A) All are right hands B) don't have skeletal- muscular injuries C) range of age between 8 to 13 years D) sex: male E) Do not have a history of engagement in protocols of motor imagery training F) Have a specific schedule for sleeping and eating G) Based on DSM-V criteria, autism spectrum disorder has been identified for these children. Exclusion criteria: A) another disorder, such as epilepsy, cerebral palsy or Down syndrome, and all kinds of mental retardation have been diagnosed For them B) Have a history of basketball practice C) Have a history of admission to mental hospitals D) Have a history of using psychoactive drugs
Intervention groups
Control group: The children of this experimental group are engaged in their common occupational therapeutic and psychological interventions. Intervention group: Children will take part in motor imagery training that will be delivered in 5 sessions per hour In addition common occupational therapeutic and psychological interventions.
Main outcome variables
dynamic and static balance, aiming and catching, hand dexterity

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181211041929N1
Registration date: 2019-01-30, 1397/11/10
Registration timing: registered_while_recruiting

Last update: 2019-01-30, 1397/11/10
Update count: 0
Registration date
2019-01-30, 1397/11/10
Registrant information
Name
Saeid Ahar
Name of organization / entity
Kharazmi university of Tehran
Country
Iran (Islamic Republic of)
Phone
+98 21 8835 4734
Email address
std_saeid.ahar@khu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-30, 1397/11/10
Expected recruitment end date
2019-02-24, 1397/12/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Predictive Control of Movement in High Functioning Autism Spectrum Disorder Children: Combine Approach for Motor Skills Leaning
Public title
Motor Skills Leaning in High Functioning Autism Spectrum Disorder Children
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
All are right hands don't have skeletal- muscular injuries range of age between 8 to 13 years sex: male Do not have a history of engagement in protocols of motor imagery training Have a specific schedule for sleeping and eating Based on DSM-V criteria, autism spectrum disorder has been identified for these children.
Exclusion criteria:
another disorder, such as epilepsy, cerebral palsy or Down syndrome, and all kinds of mental retardation have been diagnosed For them Have a history of basketball practice Have a history of admission to mental hospitals Have a history of using psychoactive drugs
Age
From 8 years old to 13 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
A) Randomization method: Simple randomization (random number table) B) Building Random sequence method: Determining beforehand reading the table (up, down, right, left) then we start reading numbers from 0 to 50 intervention groups and 51 to 99 control groups. C) Randomization unit: Individual D) Randomization Tool: Random number table, sealed envelopes (for making random sequences) E) Concealment: Snose method A number of aluminum-covered envelopes (in order to keep the contents of the envelopes unclear) are prepared and each random sequence created on the card is recorded and the cards are inserted into the envelopes respectively. In order to maintain a random sequence, the numbering of the envelopes on the outer surface is done in the same order. Finally, the flap is closed in pockets and placed in the box, respectively. At the time of registration of the participants, according to the order in which the participants are entered, one of the envelopes is opened and the allocated group of that participant is made known.
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
Ethics Committee on Biomedical Research in Tarbiat Modares University
Street address
Jalal AleAhmad Blvd, Nasr bridge, Tehran
City
Tehran
Province
Tehran
Postal code
14115-111
Approval date
2018-12-09, 1397/09/18
Ethics committee reference number
IR.MODARES.REC.1397.140

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
Before the intervention and the end of the intervention
Method of measurement
Movement assessment battery for children

2

Description
Hand dexterity
Timepoint
Before the intervention and the end of the intervention
Method of measurement
Movement assessment battery for children

3

Description
Aiming and catching
Timepoint
Before the intervention and the end of the intervention
Method of measurement
Movement assessment battery for children

4

Description
Penalty of basketball
Timepoint
Before the intervention and the end of the intervention
Method of measurement
The result of the throwing basketball ball to the ring is calculated as 7 points

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Children will take part in motor imagery training that will be delivered in 5 sessions per hour In addition common occupational therapeutic and psychological interventions based on ABA method.
Category
Rehabilitation

2

Description
Control group: The children of this experimental group are engaged in their common occupational therapeutic and psychological interventions based on ABA method.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Ashtari Rehabilitation Clinic
Full name of responsible person
Mahnaz Ashtari
Street address
No. 6, side of Yazdi Dairy shopping, Ashrafi Esfahani mosque Ave, Marzardan Blvd, Tehran.
City
Tehran
Province
Tehran
Postal code
1145676914
Phone
+98 21 6634 3060
Email
m.ashtari@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kharazmi University
Full name of responsible person
Jafar Jahanpanah
Street address
Kharazmi University, No.43. South Mofatteh Ave, Tehran, iran
City
Tehran
Province
Tehran
Postal code
15719-14911
Phone
+98 21 8884 8944
Email
jahanpanah@khu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kharazmi 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
The university of Kharazmi
Full name of responsible person
Saeid Ahar
Position
Student
Latest degree
Master
Other areas of specialty/work
Sport Sciences
Street address
Kharazmi University, No.43. South Mofatteh Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1571914911
Phone
+98 21 8832 9220
Email
saeid.ahar@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Kharazmi
Full name of responsible person
Farhad Ghadiri
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Sciences
Street address
Address: No. 43, Shahid Mofatteh Ave., Kharazmi University, Faculty of Physical Education & Sport Sciences, Tehran.
City
Tehran
Province
Tehran
Postal code
1571914911
Phone
+98 21 2225 8081
Email
ghadiri671@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
The university of Kharazmi
Full name of responsible person
Saeid Ahar
Position
Student
Latest degree
Master
Other areas of specialty/work
Sport Sciences
Street address
Kharazmi University, No.43. South Mofatteh Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1571914911
Phone
+98 21 8832 9220
Email
saeid.ahar@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not 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
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
The data that the output of the movement assessment battery for children is without identifying the subjects of the subject.
When the data will become available and for how long
6 months after printing results
To whom data/document is available
All interested persons
Under which criteria data/document could be used
There is no specific item.
From where data/document is obtainable
Send an email to saeid.ahar@gmail.com
What processes are involved for a request to access data/document
After posting, it will take two weeks for the documentation to reach.
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