The main purpose of this study was to study The effect of Insoles with different Wedge on balance control with and without visual input before and after fatigue in healthy individuals
Design
This research was carried out at the Bu-Ali Sina University Rehabilitation Research Laboratory. Which includes pre-test and post-test in one session. Twenty female volunteers from the University who had normal navicular elevations participated in the study and performed equilibrium tests with three different insoles.
Settings and conduct
The Present study is a semi-experimental research based on the desing, the method os selecting the subject,the measurment tools and the intervention, and the research design was pre-test and post- test on one Sesión
Participants/Inclusion and exclusion criteria
no history of surgery, fracture, burn, musculoskeletal problems, back pain or severe trauma in the lower extremity during the last six months of the study and dominance of the right foot, as well as having normal navicular height the criteria for entering the research.Having lower limb damage, having a history of lower limb surgery, balance disorders such as Atrial System disorders, lower extremity abnormalities, spine and legs.
Intervention groups
A group of 20 people performed equilibrium tests using three types of insoles
Main outcome variables
Prevention of injury,Improved static and Dynamic balance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171225038072N1
Registration date:2018-09-02, 1397/06/11
Registration timing:retrospective
Last update:2018-09-02, 1397/06/11
Update count:0
Registration date
2018-09-02, 1397/06/11
Registrant information
Name
Azadeh Asgarpoor
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3436 7105
Email address
azadehasgarpoor@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-11-05, 1395/08/15
Expected recruitment end date
2017-01-10, 1395/10/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of InsolesWith Different Wedge on Balance control With andWithout Visual input before and after fatigue In healthy people
Public title
The effect of the insoles on the Proprioception of the floor and ankle in balance control
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
no history of surgery
fracture
burn
musculoskeletal problems
back pain or severe trauma in the lower extremity during the last six months of the study
and dominance of the right foot as well as having normal navicular height
Exclusion criteria:
Having lower limb damage
having a history of lower limb surgery
balance disorders such as Atrial System disorders
, lower extremity abnormalities, spine and legs
Age
From 20 years old to 24 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
The researcher has by no means interfered in test neither in pre-test and post-test.the tests were given by individuals who had not clue about the plan.the participants were not alter of test application as well and just acted to instruction.the person who analyzed the data did know about the study and generally looked at the data.
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamedan University of Medical Sciences
Street address
Pajohesh Intersection, Mahdieh Street
City
Hamedan
Province
Hamadan
Postal code
65178
Approval date
2017-11-11, 1396/08/20
Ethics committee reference number
IR.UMSHA.REC.1396.652
Health conditions studied
1
Description of health condition studied
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
the balanceدر یک
Timepoint
At the beginning of the study, when using the Insoles and at the same time after the fatigue
Method of measurement
Boydx System Balance
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Performing equilibrium tests using three types of insoles
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
The University Bu Ali Sina
Full name of responsible person
Ali Yalfani
Street address
Pajohesh Intersection,Mahdieh stereet
City
Hamedan
Province
Hamadan
Postal code
38695_65178
Phone
+98 81 3838 1422
Email
Ali_Yalfani@Yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Bu-Ali Sina
Full name of responsible person
Gholam Hossein Majzoobi
Street address
University of Bu-Ali Sina , Pajohesh intersection, Mahdieh Street
City
Hamedan
Province
Hamadan
Postal code
65178-38695
Phone
+98 81 3827 2072
Email
gh_majzoobi@basu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Bu-Ali Sina
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 Bu-Ali Sina
Full name of responsible person
Azadeh Asgarpoor
Position
Masters Student
Latest degree
Master
Other areas of specialty/work
Corrective Exercises and Sport Injuries
Street address
No. 4, Alley 44., Saadi east Street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816784365
Phone
+98 38 3225 2809
Email
azadehasgarpoor@gmail.cim
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Bu-Alh Sina
Full name of responsible person
Azadeh Asgarpoor
Position
Masters Student
Latest degree
Master
Other areas of specialty/work
Corrective Exercises and Sport Injuries
Street address
No.4, Alley 44., Saadi east Street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816784365
Phone
+98 32252809
Email
azadehasgarpoor@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
The University Bu-Ali Sina
Full name of responsible person
Azadeh Asgarpoor
Position
Masters Student
Latest degree
Master
Other areas of specialty/work
Corrective Exercises and Sport Injuries
Street address
NO.4., Alley 44., Saadi east Street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816784365
Phone
+98 32252809
Email
azadehasgarpoor@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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be 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
Data and documentation can be shared, but with the unidentifiable individuals and the private information of the subjects
When the data will become available and for how long
Starting data access 1 year after printing results
To whom data/document is available
Researchers in this field are allowed to act for documentation
Under which criteria data/document could be used
Only the type of analysis that can be done in the research can be redefined
From where data/document is obtainable
azadehasgarpoor@gmail.com
What processes are involved for a request to access data/document
When an applicant submits a document for his / her work area in relation to the subject matter of the thesis and, if reasonable request, and the commitment not to misuse the data of this research , the data will be sent to him within1 week' of work