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Acute and chronic effects of lateral wedge insoles with different inclination on biomechanical variables associated with osteoarthritis of the knee in individuals with genu varum

Protocol summary

Study aim
1. The study on the immediate and long term effect of lateral wedge insoles with different inclination on Knee adduction torque in individual having genu varum with similar foot structure in support phase of running.
Design
By completing the pretest, the subjects were randomly divided into experimental and control groups. The experimental group is divided into three subgroups. then we first assign a number to each participant and use the lottery to select the required number for each group. The experimental groups use an insemin for eight weeks. After two months of, subjects in each group repeat the steps as post-tests.
Settings and conduct
The place of this study is Tehran. The test is recorded in five conditions: barefooted, with shoes, external inclination with gradients 0, 5, 10 for all subjects. They begin their movement from four meters of the board and by getting a controlled rhythm, the average of three successful attempts with the following characteristics is recorded. - impact of the foot with a ergometer board at the support stage of running. - The subject will naturally run and do not set his foot for a contact on board only.
Participants/Inclusion and exclusion criteria
Entry criteria: Having a 3rd grade parenthesis and age range of 20-35 years Exit criteria, having or history of: BMI greater than 30, lower limb joint rehabilitation program or fracture and surgery, osteoarthritis, ligament injury or knee minisc, use of foot and trunks in the six months before the measurement and systemic diseases
Intervention groups
Subjects were divided into four groups. The control group is without any intervention, but each of other three groups as an experimental group uses an external insoles that their inclination are different as 0, 5 and 10 degrees.
Main outcome variables
External insoles with different inclination percent Biomechanical variables related to knee osteoarthritis

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190414043273N1
Registration date: 2019-06-13, 1398/03/23
Registration timing: retrospective

Last update: 2019-06-13, 1398/03/23
Update count: 0
Registration date
2019-06-13, 1398/03/23
Registrant information
Name
mehdi GHEITASI
Name of organization / entity
The University of Shahid beheshti
Country
Iran (Islamic Republic of)
Phone
+98 21 2990 5839
Email address
imeri@gonbad.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-05, 1398/02/15
Expected recruitment end date
2019-06-05, 1398/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Acute and chronic effects of lateral wedge insoles with different inclination on biomechanical variables associated with osteoarthritis of the knee in individuals with genu varum
Public title
effects of lateral wedge insoles withon biomechanical variables associated with osteoarthritis of the knee
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
People with a Genu Varum
Exclusion criteria:
The history of the use of medical shoes and footwear in six months before the measurement Having a BMI of over 30
Age
From 25 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 10
Randomization (investigator's opinion)
Randomized
Randomization description
In this method, we first assign all the participants in the numerical study and use the lottery to select the required number for each 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
Iran University of Medical Sciences
Street address
Tehran Hemat Highway next to Milad Tower 14496، 14535
City
Tehran
Province
Tehran
Postal code
14535 14496
Approval date
2019-02-23, 1397/12/04
Ethics committee reference number
IR.IUMS.REC.1397.1348

Health conditions studied

1

Description of health condition studied
Genu Varum
ICD-10 code
M21.1
ICD-10 code description
Varus deformity, not elsewhere classified

Primary outcomes

1

Description
Independent variable: insoles
Timepoint
eight weeks
Method of measurement
Hammer's General Health Questionnaire, Scale to measure anthropometric characteristics, foot scan to examine the type of plantar, ergometer machine, camera and marker to record motion and calculate the external knee attachment torque

2

Description
dependent variables: Genu Varum
Timepoint
eight weeks
Method of measurement
Hammer's General Health Questionnaire, Scale to measure anthropometric characteristics, foot scan to examine the type of plantar, ergometer machine, camera and marker to record motion and calculate the external knee attachment torque

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: The intervention include use of semi-custom shoe insoles with an external gradient of 0 ° for eight weeks.
Category
Prevention

2

Description
Intervention group 2: Use of semi-custom shoe insoles with an external gradient of 5 ° for eight weeks.
Category
Prevention

3

Description
Intervention group 3: Use of semi-custom shoe insoles with an external gradient of 10 ° for eight weeks.
Category
Prevention

4

Description
Control group: They will not experience an intervention, and they will experience the use of their normal and insane shoes for eight weeks.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Firoozgar Hospital
Full name of responsible person
Gholamreza Raeisi
Street address
Tehran, Vali-e-Asr Square, Karim Khan Zand Avenue, Beh Afarin Street
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1201
Fax
+98 21 8894 2622
Email
h_firoozgar@yahoo.com
Web page address
http://firoozgar.iums.ac.ir/?fkeyid=&siteid=52&pageid=15385

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
seyed Kazem Malakoti
Street address
Tehran Hemat Highway next to Milad Tower 14496، 14535
City
Tehran
Province
Tehran
Postal code
14496، 14535
Phone
+98 21 8670 2538
Email
malakouti@iums.ac.ir
Web page address
http://iums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Gholamreza Raeisi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Behafarin Ave, Karimkhan Blvd
City
Tehran
Province
Tehran
Postal code
۱۵۹۳۷۴۷۸۱۱
Phone
+98 82141600
Email
raissi.gh@iums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Shahid Beheshti
Full name of responsible person
Mehdi Gheitasi
Position
Assistance professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Evin Ave
City
Tehran
Province
Tehran
Postal code
۱۹۸۳۳۹۶۹۴۱۱
Phone
+98 21 2990 5839
Email
mehdi.gheitasi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
The University of Shahid Beheshti
Full name of responsible person
Mehdi Gheitasi
Position
Assistance professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport science and Health
Street address
Evin Ave
City
Tehran
Province
Tehran
Postal code
19833969411
Phone
+98 21 2990 5839
Email
mehdi.gheitasi@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Data will only be presented in general and in the results of the report of study.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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