The Effect of 12 week corrective exercises on radiological indices of lower limb alignment, Proprioception and Balance in Patients with Osteoarthritis with Varus Knee Deformity
Investigating the effect of 12 weeks of corrective exercises on the radiological indicators of the lower limbs, proprioception and balance in patients with osteoarthritis with varus knee.
Design
The current study has two intervention groups: 1- experimental intervention group that will perform corrective exercises 2- control intervention group with specific quadriceps and hamstring exercises, a clinical trial study type with a control group, with parallel groups
Settings and conduct
The first step: selection of students based on the entry criteria
Second step: grouping
The third stage: pre-test
The fourth stage: three months of training
Fifth step: pre-test
The place of testing was in the laboratory of Faculty of Physical Education and Sports Sciences of Shahid Beheshti University of Tehran and Alborz Sports Complex.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having knee pain for 6 months or more; Having knee varus deformity (the distance between the knees is more than 2.5 cm); Having limited Range of Motion and Functional score II and III based on clinical and radiological signs.
Exclusion criteria: Failure to participate in two consecutive and three non-consecutive training sessions; Progression of symptoms and pain and ihe patient's unwillingness to continue treatment.
Intervention groups
Experimental group (corrective exercises). Control group: the control group continued their daily activities during the implementation of the project.
Main outcome variables
Radiological indicators of lower limb alignment, proprioception and balance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180414039299N2
Registration date:2025-01-04, 1403/10/15
Registration timing:retrospective
Last update:2025-01-04, 1403/10/15
Update count:0
Registration date
2025-01-04, 1403/10/15
Registrant information
Name
Mohsen Moradi
Name of organization / entity
The University of Kharazmi
Country
Iran (Islamic Republic of)
Phone
+98 24 3352 2824
Email address
mohsenmoradi90@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-10-22, 1403/08/01
Expected recruitment end date
2024-11-20, 1403/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of 12 week corrective exercises on radiological indices of lower limb alignment, Proprioception and Balance in Patients with Osteoarthritis with Varus Knee Deformity
Public title
The Effect of 12 week corrective exercises on radiological indices of lower limb alignment, Proprioception and Balance in Patients with Osteoarthritis with Varus Knee Deformity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having knee pain for 6 months or more.
Having knee varus deformity (the distance between the knees is more than 2.5 cm).
Having limited Range of Motion.
Functional score II and III based on clinical and radiological signs.
Exclusion criteria:
Failure to participate in two consecutive and three non-consecutive training sessions.
Progression of symptoms and pain.
The patient's unwillingness to continue treatment.
Age
From 55 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
Using randomized permuted block randomization (7 blocks of size 8), the two treatment combinations are independently assigned to participants in a 1:1 ratio (after the initial assessment). Randomized sequence listing is done by computer (Pocock SJ. Clinical Trials: A Practical Approach. Wiley; 1983) and also by website (https://www.randomizer.org). This step will be ensured by a blind evaluator.
Blinding (investigator's opinion)
Single blinded
Blinding description
Outcome assessors will be blinded to group allocation. Participants will not be blinded to study and grouping, but will be blinded to the intervention they are receiving (there is an unavoidable risk of bias in this study that the intervention cannot be blinded to interventionists, patients). Before the evaluation, the necessary training will be given to the outcome evaluator in relation to how to evaluate the variables in order to prevent any questions and answers between the evaluator and the subjects.
The First of all, Measuring the parameters of radiological indices of the lower limb in the post-test, and then after twelve weeks, measuring the parameter of radiological indices of the lower limb in the pre-test
Method of measurement
Radiographs were taken in the standard position and bearing weight of the entire length of the lower limb.
2
Description
Proprioception
Timepoint
First, Measuring the parameter proprioception in the post-test, and then after eight weeks, Measuring the parameter of proprioception in the pre-test
Method of measurement
Knee joint position sense was measured by goniometer.
3
Description
Balance
Timepoint
First, Measuring the parameter Balance in the post-test, and then after eight weeks, Measuring the parameter of balance in the pre-test
Method of measurement
Stork test was used to measure static balance and Y test was used to measure dynamic balance.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this study, the combination of theraband and strength exercises was used for the training group. In this research, the use of the Theraband exercise protocol approved by the Medical College of Georgia, University of Nursing, Augusta, Georgia, USA for people with knee osteoarthritis, adapted to Joost Decker's 2014 recommendation and based on special recommendations The American College of Sports Medicine (ACSM) was implemented based on the principles of exercise science, each training session consisted of 10 minutes of warm-up, the main part of the exercises was 30-50 minutes, and 5 minutes of cooling down. There was a 2-minute rest between each exercise. The exercises were performed for 12 weeks and in the form of 3 sessions per week. Yellow, red, and green tapes were used to perform the theraband exercises, and the repetition of each exercise was 8 to 12 times per leg. Also, in the strength training program, attention was paid to the ability of the participants, and each session added repetitions or movement time.
Category
Rehabilitation
2
Description
The control group continued their daily activities during the implementation of the project.
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shahid Beheshti university
Proportion provided by this source
50
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
Kharazmi University
Full name of responsible person
Mohsen Moradi
Position
Ph.D
Latest degree
Ph.D.
Other areas of specialty/work
Corrective Exercise
Street address
Kharazmi University, Faculty of Physical Education and Sport Sciences, Mirdamad Boulevard, tehran
City
Tehran
Province
Tehran
Postal code
1544733111
Phone
+98 919 345 0353
Email
Mohsenmoradi90@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kharazmi university
Full name of responsible person
Mohsen Moradi
Position
Ph.D
Latest degree
Ph.D.
Other areas of specialty/work
Corrective Exercise
Street address
Faculty of Physical Education and Sports Sciences, Mirdamad Boulevard
City
Tehran
Province
Tehran
Postal code
4519174555
Phone
+98 919 345 0353
Email
Mohsenmoradi90@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kharazmi university
Full name of responsible person
Mohsen Moradi
Position
Ph.D
Latest degree
Ph.D.
Other areas of specialty/work
Sport injury and corrective exercise
Street address
Faculty of Physical Education and Sports Sciences, Mirdamad Boulevard
City
Tehran
Province
Tehran
Postal code
4519174555
Phone
+98 919 345 0353
Email
Mohsenmoradi90@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
The information related to the variables of the radiological indicators of the lower limbs, proprioception and balance are recorded in the pre-test and after twelve weeks of training, the information of the mentioned variables are recorded in the post-test and the results of the changes are recorded.
When the data will become available and for how long
After publishing the article/articles extracted from the study
To whom data/document is available
The data can be displayed and shared upon the reasonable request of Iran's Clinical Trial Registration Center, journals and academic people/researchers who are conducting research and scientific activities in this field.
Under which criteria data/document could be used
Data analysis and the use of documentation can only be done under the condition that their results are reported in scientific articles by academic researchers and authors. The necessary conditions for sending data and documents include: 1. Sending an email (preferably with valid university addresses) to one of the researchers of the study. 2. A brief and logical explanation related to the use of data or documents.
From where data/document is obtainable
Through request from researcher Mohsen Moradi Mohsenmoradi90@gmail.com
What processes are involved for a request to access data/document
The applicant can request details from the researchers using the message sent by email within 7 to 10 days