Comparison of the effect of lateral wedge with and without hip and trunk muscle strengthening on balance of young people with genu varum
Design
Two arm parallel group without blinding randomised trial of 40 patients
Settings and conduct
Study of balance with force plate during standing walking and jumping at laboratory of Shahid Beheshti of Medical Sciences.First he or she stands with two legs and with open eyes on forceplate for 1 minute. This test is repeated 3 times. Then walks in a specific path with bare feet so that the dominant limb is placed on the force plate. This test is repeated 3 times. Finally, he or she performs the jump-landing. Before performing the task to normalize the vertical height of the jump, it is necessary to calculate 50% of the maximum jump height. Then he or she stands behind the mark that is determined and the person jumps with two legs and the 50% maximum jump mark is touched with one hand and with the dominant leg lands single leg for 20s. This test is repeated 3 times. Subjects are divided into two groups of control and intervention and one month later these tests are repeated again and data related to static and dynamic balance indices are compared.
Participants/Inclusion and exclusion criteria
inclusion criteria
1.with bilateral genu varum at 18-40 ages
exclusion criteria
1.other lower extremity deformities
2. history of corrective surgery of spine and lower extremity, fracture
3.vision, ear, balance, cognitive problems
4.professional athlete
5.walking with auxillary devises
Intervention groups
group 1 using lateral wedge without exrecise . group 2 using lateral wedge with hip and trunk muscle strengthening exercises.
Main outcome variables
velocity and displacement of foot pressure center in anterior-posterior, medial-lateral, ground reaction force and time to stabilization
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221103056387N1
Registration date:2023-04-03, 1402/01/14
Registration timing:registered_while_recruiting
Last update:2023-04-03, 1402/01/14
Update count:0
Registration date
2023-04-03, 1402/01/14
Registrant information
Name
Nafiseh Shahri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4495 2297
Email address
shahri.nafiseh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-06, 1401/12/15
Expected recruitment end date
2023-06-20, 1402/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of the effects of lateral wedges with and without hip and trunk muscles strengthening on balance in young people with genu varum
Public title
the effects of lateral wedges with and without hip and trunk muscles strengthening on balance in young people with genu varum
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
genuvarum deformity
bilateral deformity
age between 18-40
Exclusion criteria:
other deformity such as anteversion
corrective surgery of the spine and lower extremity
Balance and cognitive problems, ear, vision and neuromuscular skeletal
need help for walking and use auxiliary Equipment
history of fracture and trauma in last year
professional Athlete
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization
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 Shahid Beheshti University of Medical Sciences
Street address
No.21, Javaherian alley, Motahari street, Central Payambar street, Tehran
City
Tehran
Province
Tehran
Postal code
1471844855
Approval date
2022-06-26, 1401/04/05
Ethics committee reference number
IR.SBMU.RETECH.REC.1401.149
Health conditions studied
1
Description of health condition studied
genu varum (bow leg)
ICD-10 code
M21.169
ICD-10 code description
Varus deformity, not elsewhere classified, unspecified knee
Primary outcomes
1
Description
velocity and displacement of pressure center of foot, ground reaction force and time to stabilization
Timepoint
at the begining of study (before of treatment) and 1 month later
Method of measurement
forceplate
Secondary outcomes
empty
Intervention groups
1
Description
"Control group:" using lateral wedge in shoes for one month
Category
Treatment - Devices
2
Description
"Intervention group:" using lateral wedge in shoes with hip and trunk strengthening exercises for one month . exercises should be done 3 times in a day
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Rehabilitation Science School of Shahid Beheshti Medical science
Full name of responsible person
Nafiseh Shahri
Street address
Rehabilitation Science School of Shahid Beheshti Medical sciencebDamavand street, Emam Hosein square,Tehran
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7754 8496
Email
rehab.sbmu@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Sedighe sadat Naimi
Street address
Damavand street, Emam Hosein square, Tehran
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7715 9535
Email
rehab.sbmu@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nafiseh Shahri
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No.21, Javaherian alley, Motahari street, Central Payambar street, Tehran
City
Tehran
Province
Tehran
Postal code
1471844855
Phone
+98 21 4495 2297
Email
shahri.nafiseh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nafiseh Shahri
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No.21 Javaherian alley, Motahari street, Central Payambar street, Tehran
City
Tehran
Province
Tehran
Postal code
1471844855
Phone
+98 21 4495 2297
Email
shahri.nafiseh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nafiseh Shahri
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No. 21, Javaherian Ave, MO Tahari Blvd, Central Payambar Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1471844855
Phone
+98 21 4495 2297
Fax
Email
Shahri.nafiseh@gmail.com
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
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
Undecided - It is not yet known if there will be a plan to make this available