Balance Training Using Biodex Stability System in Knee Osteoarthritis.

Study Overview
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Brief Summary
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This was a randomized control Trial, conducted with two group of patients, one has received Balance and stability training on Biodex stability system along with conservative protocol of traditional exercises. the other group has received only conservative protocol of traditional exercises

Detailed Description
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Patients with Symptomatic Knee Osteoarthritis have balance and stability deficits. In routine such patients are not evaluated and treated on balance and stability parameters. So this study was conducted with objectives to determine the effects of Balance training using Biodex stability system in patients with symptomatic knee osteoarthritis. Experimental group has received Balance and stability training on Biodex stability system along with conservative protocol of traditional exercises. Control group has received only conservative protocol of traditional exercises.

Official Title
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Effects of Balance Training Using Biodex Stability System in Patients With Symptomatic Knee Osteoarthritis.

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Other: Balance Training
* Other: Conventional Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Bilateral knee pain Age 35-65, Both genders Grade 2 or 3 on Kellgren classification for Knee Arthritis Exclusion Criteria: Past history of total knee artthroplasty Intra articular steroid injection Rheumatoid Arthritis Use of Assistive devices e.g. canes, walkers and braces Knee injury

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Assignment of patients into two groups
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I<br>The experimental group was treated with Balance Training on Biodex Stability System along with traditional exercises. | Other: Balance Training<br>* Experimental group received balance training on Biodex stability System along with traditional exercise program. During balance training on Biodex, patients were instructed to stand on the platform with bare feet with open eyes and both legs supported. Patients were looking forward to screen having hands hang by the sides. The patients were instructed not to change their feet position and balance the body. The handles were accessible for safety point. But touching the handles cancelled the trail. Total time of training was 10 minutes each set is of 3 minutes with 20 sec rest intervals.<br>|
| Active Comparator: Group II<br>The Control group was treated with Traditional exercises only for Symptomatic knee osteoarthritis. | Other: Conventional Training<br>* Control group has received traditional exercises i.e Quadriceps strength exercises, Hamstrings flexibility exercises and Balance exercises.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time up and Go test (TUG) | Patients were asked to perform test at usual walking speed. Initial testing standardized verbal instructions given to the participant regarding procedure. For performing TUG participants were instructed to walk three meter and then, walk back to sit down. Note time on stopwatch. The average of tests trail was measured as the mean of TUG. | Baseline | 
| Time up and Go test (TUG) | Patients were asked to perform test at usual walking speed. Initial testing standardized verbal instructions given to the participant regarding procedure. For performing TUG participants were instructed to walk three meter and then, walk back to sit down. Note time on stopwatch. The average of tests trail was measured as the mean of TUG. | Post 4th Week | 
| overall stability index (OSI) | Measures were obtained from 20-sec trials during which participants were asked to maintain an upright standing position on their dominant limb on the unstable surface of the Biodex Stability and Balance System.Its reliability is R = .94 | Baseline | 
| overall stability index (OSI) | Measures were obtained from 20-sec trials during which participants were asked to maintain an upright standing position on their dominant limb on the unstable surface of the Biodex Stability and Balance System.Its reliability is R = .94 | Post 4th Week | 
| Anterior-posterior stability index (APSI) | Measures were obtained from 20-sec trials during which participants were asked to maintain an upright standing position on their dominant limb on the unstable surface of the Biodex Stability and Balance System.Its reliability is R = .95 | Baseline | 
| Anterior-posterior stability index (APSI) | Measures were obtained from 20-sec trials during which participants were asked to maintain an upright standing position on their dominant limb on the unstable surface of the Biodex Stability and Balance System.Its reliability is R = .95 | Post 4th Week | 
| Medial-lateral stability index (MLSI) | Measures were obtained from 20-sec trials during which participants were asked to maintain an upright standing position on their dominant limb on the unstable surface of the Biodex Stability and Balance System.Its reliability is R = .93 | Baseline | 
| Medial-lateral stability index (MLSI) | Measures were obtained from 20-sec trials during which participants were asked to maintain an upright standing position on their dominant limb on the unstable surface of the Biodex Stability and Balance System.Its reliability is R = .93 | Post 4th Week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric Pain Rating Scale (NPRS) | Numeric Pain Rating Scale (NPRS) is used to assess pain. It scores ranges from 0-10, 0 means No pain and 10 means Severe pain. Patient will be asked to verbally report the pain score. | Baseline | 
| Numeric Pain Rating Scale (NPRS) | Numeric Pain Rating Scale (NPRS) is used to assess pain. It scores ranges from 0-10, 0 means No pain and 10 means Severe pain. Patient will be asked to verbally report the pain score. | post 4th week | 
| Western Ontario and McMaster Universities Arthritis Index (WOMAC) | It is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: Pain (5 items):Stiffness (2 items): Physical Function (17 items). The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a total WOMAC score.Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. | Baseline | 
| Western Ontario and McMaster Universities Arthritis Index (WOMAC) | It is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: Pain (5 items):Stiffness (2 items): Physical Function (17 items). The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a total WOMAC score.Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. | Post 4th week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Balance Training, Biodex stability system, Osteoarthrosis, Degenerative, Stability exercises