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The Effect of Vestibular Stimulation Exercises on Balance and some Motor skills of Intellectual Disability Children with balance impairment

Protocol summary

Study aim
The Effect of Vestibular Stimulation Exercises on Balance and some Motor skills of Intellectual Disability Children with balance impairment
Design
a randomized single-blind clinical trial with intervention and control groups.parallel group, according to the centralized and computerized study
Settings and conduct
The study is conducted at the Khazaeli School of Rasht city, as well as single-blind design
Participants/Inclusion and exclusion criteria
Imbalance performance- an intellectual disability-The age group is 7-12 years old
Intervention groups
intervention group: Vestibular Stimulation Exercises -control group: without training program.
Main outcome variables
vestibular-balance

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190427043393N1
Registration date: 2019-05-07, 1398/02/17
Registration timing: prospective

Last update: 2019-05-07, 1398/02/17
Update count: 0
Registration date
2019-05-07, 1398/02/17
Registrant information
Name
Malihe Sharifi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3411 4622
Email address
malihesharifi6971@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-10, 1398/02/20
Expected recruitment end date
2019-07-11, 1398/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Vestibular Stimulation Exercises on Balance and some Motor skills of Intellectual Disability Children with balance impairment
Public title
effect of motor training on balance in intellectual disability
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
being in the group of intellectual disability did not have visual and hearing impairment having a balance function disorder
Exclusion criteria:
having any physical and motor impairment having other disability use of special medication
Age
From 12 years old to 7 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
subject are randomly assigned with help of a random number table in one of the two group and receive related intervention
Blinding (investigator's opinion)
Single blinded
Blinding description
The selected training sessions of intervention group were blinded without knowledge of being in intervention or control groups
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
ethics committee of guilan university of medical sc
Street address
shahid siadaty ave, namjoo str, rasht
City
rasht
Province
Guilan
Postal code
4188794755
Approval date
2019-03-13, 1397/12/22
Ethics committee reference number
IR.GUMS.REC.1397.478

Health conditions studied

1

Description of health condition studied
intellectual disability patient
ICD-10 code
F71
ICD-10 code description
Moderate intellectual disabilities

Primary outcomes

1

Description
balance
Timepoint
measurement of balance tests before and after of 6 week intervention
Method of measurement
functional test of balance

2

Description
Coarse motor skills
Timepoint
measurement of balance tests before and after of 6 week intervention
Method of measurement
Subtest of Bruninks Oseretsky Test

3

Description
fine motor skills
Timepoint
measurement of balance tests before and after of 6 week intervention
Method of measurement
Subtest of Bruninks Oseretsky Test

4

Description
The Timed Up and Go
Timepoint
measurement of balance tests before and after of 6 week intervention
Method of measurement
The duration of this test

Secondary outcomes

1

Description
"intervention group 1"
Timepoint
"Measure relevant tests after 6 weeks"
Method of measurement
" Bruninks Oseretsky Test "

2

Description
"control group"
Timepoint
"Measure relevant tests after 6 weeks"
Method of measurement
" Bruninks Oseretsky Test "

Intervention groups

1

Description
"Intervention group"
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
KHazaeli's exceptional school
Full name of responsible person
GHazalgeh Tahereh
Street address
KHazaeli's exceptional school-Higher than the police station 15-Modares freeway-Pirklauchai
City
Rasht
Province
Guilan
Postal code
4189845353
Phone
+98 13 3381 0081
Email
k.azarnoosh@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mirhoseini Seyed Ziaaedin
Street address
5th Kilometer Gazvin rote,KHalije farse Highway,Rasht down
City
Rasht
Province
Guilan
Postal code
4199613776
Phone
+98 13 0338 3369
Email
szmirhoseini@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Rasht 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
Rasht University of Medical Sciences
Full name of responsible person
SHarifi Malihe
Position
Msc student
Latest degree
Bachelor
Other areas of specialty/work
Sport injury and corrected exercise
Street address
Faculty of physical education and sport science.5th Kilometer Gazvin-Tehran rot,Rasht
City
Rasht
Province
Guilan
Postal code
4199613776
Phone
+98 13 3375 3395
Email
malihesharifi6971@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rasht university of medical sciences
Full name of responsible person
SHarifi Malihe
Position
Msc student
Latest degree
Bachelor
Other areas of specialty/work
sport injury and corrected exercised
Street address
Faculty phisical education and sport science,5th Gazvim-Tehran rote, Rasht
City
Rasgt
Province
Guilan
Postal code
4199613776
Phone
+98 13 3375 3395
Email
malihesharifi6971@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Rasht university of medical Sciences
Full name of responsible person
SHarifi Malihe
Position
Msc student
Latest degree
Bachelor
Other areas of specialty/work
Sport injury and corrective exercised
Street address
Faculty physical education and sport science,5th Kilometer Gazvin-Tehran road,Rasht
City
Rasht
Province
Guilan
Postal code
4199613776
Phone
+98 13 3375 3395
Email
malihesharifi6971@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
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data of variables measured after unidentifiable individuals can be shared.
When the data will become available and for how long
Starting the access period from 2020
To whom data/document is available
Only for scholars working in academic and scientific institutions
Under which criteria data/document could be used
Scientific use in improving and comparing with other research is allowed
From where data/document is obtainable
E-mail address for correspondence
What processes are involved for a request to access data/document
Applicants should send the reason for using the documentation to an e-mail
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