The Effect of Vestibular Stimulation Exercises on Motor Function and Balance in Childeren with Hearing Impairment
Design
a rondomized single- blind clinical trail with intervention and control groups,parallel groups, according to the centralized and computerized study
Settings and conduct
The study is conducted at the preschool school and Ghotbzadeh primary school of Rasht city , as well as single blind design
Participants/Inclusion and exclusion criteria
Hearing-impaired subjects with a hearing loss of about 80 dB are selected
Complete satisfaction and willingness to participate in research.
Have no visual impairment
Intervention groups
Intervention group: Vestibular stimulation based on motor exercises. Control group: Do not participate in any exercise program.
Main outcome variables
vestibular, balance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190427043392N1
Registration date:2019-06-02, 1398/03/12
Registration timing:registered_while_recruiting
Last update:2019-06-02, 1398/03/12
Update count:0
Registration date
2019-06-02, 1398/03/12
Registrant information
Name
vahideh sadat mousavi zadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3411 9618
Email address
v.s.mousavizadeh@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 Motor Function and Balance in Childeren with Hearing Impairment
Public title
effect of motor exercises on the balance of children with hearing impairment
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Hearing-impaired subjects with a hearing loss of about 80 dB are selected.
Complete satisfaction and willingness to participate in research
No visual impairment
Children aged 5 to 8 years old
Exclusion criteria:
Beyond the age range of 5 to 8 years.
Subjects did not have orthopedic, cognitive, and musculoskeletal disorders.
Subjects do not have absolute deafness
Age
From 5 years old to 8 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals are randomly assigned randomly into a group or two groups using the random numbers table and they receive the intervention of the same 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
Ethics commitee of Guilan University of Medical Sciences
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.1397.479
Health conditions studied
1
Description of health condition studied
hearing loss individual
ICD-10 code
H91
ICD-10 code description
Other and unspecified hearing loss
Primary outcomes
1
Description
balance
Timepoint
measurement of balance tests before and after 6of 6 week intervention
Method of measurement
functional test of balance
2
Description
the timed up and go
Timepoint
subtest of bruninks oseretsky test
Method of measurement
the duration of this test
Secondary outcomes
1
Description
Balance"
Timepoint
Tests for relevant tests after 6 weeks"
Method of measurement
Bronkins - oseretsky test"
2
Description
Motor function
Timepoint
Tests for relevant tests after 6 weeks"
Method of measurement
Bronkins - oseretsky test"
Intervention groups
1
Description
Intervention group: The intervention group carries out a training session on Vestibular stimulation for 6 weeks, every 3 sessions per week.
Category
Rehabilitation
2
Description
Control group: There is no intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Preschool and Deaf Language School, Ghotbzadeh
Full name of responsible person
Pourfathi Hadith
Street address
Preschool school and schoolGotb zadeh elementary,Imam's sister's stepmother, Motehari street
City
Rasht
Province
Guilan
Postal code
4173653137
Phone
+98 13 3335 8501
Email
mghotbzadeh1@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 Road, Khalij fars 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
Mousavi zadeh Vahideh sadat
Position
Msc Student
Latest degree
Bachelor
Other areas of specialty/work
Sport injory and corrective exercise
Street address
Faculty of physical education and sport sience, 5th Kilometer Gazvin-tehran Road, Rasht
City
Rasht
Province
Guilan
Postal code
4199613776
Phone
+98 13 3375 3395
Email
v.s.mousavizadeh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mousavizadeh Vahidehsadat
Position
Msc Student
Latest degree
Bachelor
Other areas of specialty/work
Sport injury and corrective exercise
Street address
Faculy physical and sport sciencebRasht, 5th Kilometer Gazvin-tehran Road, Rasht
City
Rasht
Province
Guilan
Postal code
4199613776
Phone
+98 13 3375 3395
Email
v.s.mousavizadeh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Rasht Univeresity of Medical Sciences
Full name of responsible person
Mousavi zadeh Vahidehsadat
Position
Msc Student
Latest degree
Bachelor
Other areas of specialty/work
Sport injury and corrective exercise
Street address
Faculty physical education and sport science Rasht, 5th Gazvin-tehran Road, Rasht
City
Rasht
Province
Guilan
Postal code
4199613776
Phone
+98 13 3375 3395
Email
v.s.mousavizadeh@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 variable data measured after unidentifiable individuals can be shared
When the data will become available and for how long
Startingin january 2020
To whom data/document is available
Only for researchers 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.