The purpose of this study is investigation the effect of 8 weeks comprehensive corrective exercise of lower extremity kinematics in 18-28 years old men with dynamic knee valgus
Design
Single-blind randomized controlled trial
Settings and conduct
A single-blind randomized, controlled trial comparing 3 times per week group exercise intervention with a control group.
Participants/Inclusion and exclusion criteria
Have dynamic knee valguse; no history of regular exercise in last 6 months; no history of championship in any sport field; have any visible malalignment in the spine and upper extremity; failure to complete of training protocols; have a body weight outside the normal range
Intervention groups
The intervention group includes those with the dynamic knee valgus who receive the intervention of a comprehensive corrective exercise program. The control group also includes people with dynamic knee valgus who do not receive any training intervention and follow their daily activities.
Main outcome variables
Selected lower extremity kinematics factors
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180821040843N1
Registration date:2018-12-30, 1397/10/09
Registration timing:registered_while_recruiting
Last update:2018-12-30, 1397/10/09
Update count:0
Registration date
2018-12-30, 1397/10/09
Registrant information
Name
Esmaeil Mozafaripour
Name of organization / entity
The university of Tehran
Country
Iran (Islamic Republic of)
Phone
+98 21 8835 1730
Email address
e.mozafaripour@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of eight weeks comprehensive corrective exercises on selected parameters of lower extremity kinematics in men with dynamic knee valgus
Public title
The effect of comprehensive corrective exercises on dynamic knee valgus
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Have dynamic knee valgus
Without history of regular exercise in last 6 month
Without history of championship in any sport fields
Exclusion criteria:
Don’t complete the corrective exercise program
Have lack of interest in continuing the research program
Have any visible malalignment in the upper extremities
Have pathological signs
Have a history of fracture, surgery, or joint diseases in the lower extermity
Have a body weight outside the normal range
Age
From 18 years old to 28 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomly assign the subjects to the intervention and control groups, one number was considered for each subject. The numbers were randomly assigned to two groups using a random number table. To conceal numbers in each group, they were written on paper, and each one was kept in a numbered sealed, opaque envelope.
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 of Tehran University
Street address
Faculty of Physical Education and Sport Sciences, between 15th and 16th St., North Kargar st., Tehran, Islamic Republic
City
Tehran
Province
Tehran
Postal code
1417614418
Approval date
2017-07-24, 1396/05/02
Ethics committee reference number
IR.ut.Rec.1395024
Health conditions studied
1
Description of health condition studied
Dynamic knee valgus
ICD-10 code
M21.9
ICD-10 code description
Unspecified acquired deformity of limb and hand
Primary outcomes
1
Description
Lower extermity kinematics
Timepoint
Before intervention, 8 weeks after starting the intervention
Method of measurement
Motion analyse device
2
Description
Quality of one leg squat performance
Timepoint
Before intervention, 8 weeks after starting the intervention
Method of measurement
Questioner
Secondary outcomes
1
Description
quality of squat performance
Timepoint
pre test and post test
Method of measurement
quality of squat performance measurement questioner
Intervention groups
1
Description
Intervention group: The intervention group will receive comprehensive corrective exercises under supervision and 3 sessions a week. The duration of the intervention period is 8 weeks.
Category
Prevention
2
Description
Control group: There is no intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
University of Tehran
Full name of responsible person
Esmaeil mozafaripour
Street address
North Kargar
City
Tehran
Province
Tehran
Postal code
1417614418
Phone
+98 21 8835 1730
Email
e.mozafaripour@ut.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Affairs of Tehran university
Full name of responsible person
Mohammad Rahimian
Street address
North Kargar st.
City
Tehran
Province
Tehran
Postal code
1417614418
Phone
+98 21 8835 1730
Email
e.mozafaripour@ut.ac.ir
Web page address
Grant name
Research Affairs of Tehran university
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Affairs of Tehran 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
University of Tehran
Full name of responsible person
Esmaeil mozafaripour
Position
Student
Latest degree
Master
Other areas of specialty/work
corrective exercise
Street address
north kargar
City
tehran
Province
Tehran
Postal code
1417614418
Phone
+98 21 8835 1730
Email
e.mozafaripour@ut.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of tehran
Full name of responsible person
Esmaeil mozafaripour
Position
student
Latest degree
Master
Other areas of specialty/work
corrective exercise
Street address
north kargar
City
tehran
Province
Tehran
Postal code
1417614418
Phone
+98 21 8835 1730
Email
e.mozafaripour@ut.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
University of tehran
Full name of responsible person
Esmaeil Mozafaripour
Position
student
Latest degree
Master
Other areas of specialty/work
corrective exercise
Street address
north kargar
City
tehran
Province
Tehran
Postal code
1417614418
Phone
+98 21 8835 1730
Email
e.mozafaripour@ut.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Not applicable
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available