Balance and Strength Exercise in Knee Osteoarthritis Patients

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to assess the effect of balance exercise on dynamic balance and physical function in 80 patients with different grades of primary knee osteoarthritis (KOA).

Detailed Description
-----------------
The study will include 80 patients with primary knee osteoarthritis divided into 4 groups according to the Kellgren and Lawrence grading scale (KL): Group 1: 20 patients with grade I KOA Group 2: 20 patients with grade II KOA Group 3: 20 patients with grade III KOA Group 4: 20 patients with grade IV KOA Patients will undergo pre-exercise and post- exercise assessment with: Western Ontario and McMaster University Osteoarthritis Index (WOMAC) Modified Stare Excursion Balance test Timed up and Go test Exercise program includes: Lower extremity kinesthesia and balance exercise program Strength exercise program

Official Title
-----------------
The Effect of Combined Balance and Strength Exercise Program in Patients With Different Grades of Primary Knee Osteoarthritis Patients

Conditions
-----------------
Knee Osteoarthritis

Intervention / Treatment
-----------------
* Other: Balance exercise program
* Other: Strengthening exercise program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with primary knee osteoarthritis according to the EULAR recommendations 2010. Patients can complete at least stage 1 of balance and exercise program (minimum of 2 weeks) Exclusion Criteria: Patients that cannot complete at least stage 1 of balance and exercise program Patients with medical conditions affecting postural balance including visual, inner ear and neurological problems. Patients with lower limb joint or bony problems other than primary knee osteoarthritis . Patients with secondary KOA. Patients who received intra- articular joint injection in 1 or both knees in the past 90 days.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1: G I primary KOA<br>Exercise and balance training | Other: Balance exercise program<br>* Patients will be engaged in lower extremity kinesthesia and balance exercise program 3 time per week for 6 weeks. Divided into 2 stages, stage 1 and 2, each stage 3 weeks. Patients who fulfill at least stage 1 of the program will be included in the study.<br>Other: Strengthening exercise program<br>* Patients will be engaged in strengthening exercise program 3 time per week for 6 weeks. Divided into 3 stages, stage 1, 2 and 3, each stage 2 weeks. Patients who fulfill at least stage 1 of the program will be included in the study.<br>|
| Active Comparator: Group 2: G II primary KOA<br>Exercise and balance training | Other: Balance exercise program<br>* Patients will be engaged in lower extremity kinesthesia and balance exercise program 3 time per week for 6 weeks. Divided into 2 stages, stage 1 and 2, each stage 3 weeks. Patients who fulfill at least stage 1 of the program will be included in the study.<br>Other: Strengthening exercise program<br>* Patients will be engaged in strengthening exercise program 3 time per week for 6 weeks. Divided into 3 stages, stage 1, 2 and 3, each stage 2 weeks. Patients who fulfill at least stage 1 of the program will be included in the study.<br>|
| Active Comparator: Group 3: G III primary KOA<br>Exercise and balance training | Other: Balance exercise program<br>* Patients will be engaged in lower extremity kinesthesia and balance exercise program 3 time per week for 6 weeks. Divided into 2 stages, stage 1 and 2, each stage 3 weeks. Patients who fulfill at least stage 1 of the program will be included in the study.<br>Other: Strengthening exercise program<br>* Patients will be engaged in strengthening exercise program 3 time per week for 6 weeks. Divided into 3 stages, stage 1, 2 and 3, each stage 2 weeks. Patients who fulfill at least stage 1 of the program will be included in the study.<br>|
| Active Comparator: Group 4: G IV primary KOA<br>Exercise and balance training | Other: Balance exercise program<br>* Patients will be engaged in lower extremity kinesthesia and balance exercise program 3 time per week for 6 weeks. Divided into 2 stages, stage 1 and 2, each stage 3 weeks. Patients who fulfill at least stage 1 of the program will be included in the study.<br>Other: Strengthening exercise program<br>* Patients will be engaged in strengthening exercise program 3 time per week for 6 weeks. Divided into 3 stages, stage 1, 2 and 3, each stage 2 weeks. Patients who fulfill at least stage 1 of the program will be included in the study.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of pain | Using the Western Ontario and McMaster University Osteoarthritis Index (WOMAC), which contains pain sub-score and a overall total score. The higher the score the worst the pain. | 2-6 weeks | 
| Assessment of stiffness | Using the Western Ontario and McMaster University Osteoarthritis Index (WOMAC), which contains stiffness sub-score and a overall total score. The higher the score the worst the stiffness. | 2-6 weeks | 
| Assessment of physical function | Using the time up and go test, where the patient is seated and asked to get up walk a distance turn around and return to chair and sit again. It is measured using a timer, the longer the patient takes the worst the physical function of the patient. | 2-6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dynamic Balance | Using the Modified star excursion balance test which measures the patients dynamic balance in several directions, giving the patient 3 attempts and measuring each time and taking a mean of the 3 measurements in each. An increase in the measurements means better dynamic balance and a smaller measurement means worse dynamic balance. | 2-6 weeks |