The Efficacy of Balance and Proprioception Exercises in Patients With Knee Osteoarthritis

Study Overview
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Brief Summary
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This study aime to investigate the effects of balance and proprioception exercises using two different methods (classical balance training and Balance System™ SD) in addition to strengthening exercises on dynamic balance, pain, functional status and quality of life in patients with knee osteoarthritis (OA).

Detailed Description
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It is known that knee OA leads to a decrease in proprioception and balance disturbances. Falls due to balance disorders often occur during dynamic activities such as walking and stair climbing. Therefore, correction of balance disorders is of great importance to prevent falls and associated fractures in the elderly population, in which knee OA is common. In addition, loss of proprioception in the knee joint, muscle weakness, and balance disorders are also known to contribute to the development of knee OA itself. Therefore, treatment of balance disorders may also slow the progression of the disease. This study was planned to compare the effects of isometric strengthening exercises plus balance and proprioception exercises performed by two different methods with isometric strengthening exercises alone. This is a single-center randomized trial with 3 parallel arms.

Official Title
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The Efficacy of Balance and Proprioception Exercises in Patients With Knee Osteoarthritis: a Randomized Controlled Study

Conditions
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Knee Osteoarthritis, Balance; Distorted, Proprioceptive Disorders

Intervention / Treatment
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* Other: Balance and proprioception exercises
* Other: Home exercises program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients were included if they had a knee OA diagnosis according to the American College of Rheumatology (ACR) diagnostic criteria, had suffered from knee pain for at least six months, had radiologically verified bilateral knee OA of grade II or III according to the Kellgren-Lawrence classification and had not previously participated in a regular exercise program. Exclusion Criteria: Patients who had undergone knee surgery, who had received hyaluronic acid or corticosteroid injections into the knee within six months, and patients with conditions that might affect balance were excluded from the study.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

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: This study was planned to compare the effects of isometric strengthening exercises plus balance and proprioception exercises performed by two different methods with isometric strengthening exercises alone. This was a single-center randomized trial with 3 parallel arms
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Biodex Training (BT) group<br>Biodex Balance System features a platform that can move simultaneously in the anteroposterior (AP) or medio-lateral (ML) direction in 12 different levels of stability within a 20-degree range of inclination, as well as a locked position for static environments. For this platform, 1 represents the least stable level and 12 represents the most stable level. Interactive, game-like training modes are provided with the on-screen grid and score-keeping functions. Patients in the BT group performed exercises with the Balance SystemTM SD once a day, three days a week for 10 weeks under the physicians' supervision. Furthermore this group received closed kinetic chain exercises (CKCE) in addition to their own exercise program, which was applied in exactly the same way. The CKCE were performed in three sets of 10 repetitions with five seconds rest between each exercise. The exercises consisted of mini-squats, wall sits, and lunges. | Other: Balance and proprioception exercises<br>* Balance and proprioception exercises using two different methods (classical balance training and Biodex) in addition to strengthening exercises<br>|
| Active Comparator: Classical balance training group (CT group)<br>Patients in the CT group completed the exercise program once a day and three days a week during the 10-week period under the physicians' supervision. The exercises consisted of standing on one leg, tandem walking (heel-to-toe), balance board exercises, Romberg exercise, backward walking, and side-to-side stepping exercises. The total duration of these exercises was 20-30 minutes. Furthermore this group also received CKCE in addition to their own exercise program, which was applied in exactly the same way. The CKCE were performed in three sets of 10 repetitions with five seconds rest between each exercise. The exercises consisted of mini-squats, wall sits, and lunges. | Other: Balance and proprioception exercises<br>* Balance and proprioception exercises using two different methods (classical balance training and Biodex) in addition to strengthening exercises<br>|
| Active Comparator: Control group<br>Isometric home exercises, which can be considered the most basic and feasible strengthening program, were selected to compare the effects they had when added to the intervention groups and administered alone. All patients in the study performed isometric exercises for the quadriceps and hamstrings at home once a day, three days a week for 10 weeks. The exercises were performed as 10 repetitive cycles of six-second contractions and two-second rest periods. All patients were given a daily exercise chart to mark the home program, and adherence to the exercises was monitored weekly by telephone call. | Other: Home exercises program<br>* Isometric exercises for the quadriceps and hamstrings at home<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dynamic balance | The postural stability test, was performed with the following parameters: Duration: 20 seconds, Stability level: 8, and Stance: two legs. The value of overall stability index (OSI) is obtained by calculating the standard deviations of the degrees of inclination with respect to the zero point (locked position). Higher values indicate poorer equilibrium. | Baseline | 
| Dynamic balance | The postural stability test, was performed with the following parameters: Duration: 20 seconds, Stability level: 8, and Stance: two legs. The value of overall stability index (OSI) is obtained by calculating the standard deviations of the degrees of inclination with respect to the zero point (locked position). Higher values indicate poorer equilibrium. | 10th week | 
| Dynamic balance | The modified Clinical Test of Sensory Interaction and Balance (mCTSIB).The entire test is performed with the platform in the locked position. The test consists of 4 conditions: Condition 1: eyes open firm surface, Condition 2: eyes closed firm surface, Condition 3: eyes open dynamic (foam) surface, and Condition 4: eyes closed dynamic (foam) surface. The firm and dynamic surface tests assess static and dynamic balance, respectively. The conditions under which visual data are blocked are designed to detect even minor balance disturbances caused by the sensorimotor system. The sway index obtained as a result of the test represents the average position of the patient's center of mass relative to the center of the platform. Higher values indicate poorer balance. mCTSIB Condition-3, and mCTSIB Condition-4 dynamic balance assessment tests were used to assess dynamic balance. | Baseline | 
| Dynamic balance | The modified Clinical Test of Sensory Interaction and Balance (mCTSIB).The entire test is performed with the platform in the locked position. The test consists of 4 conditions: Condition 1: eyes open firm surface, Condition 2: eyes closed firm surface, Condition 3: eyes open dynamic (foam) surface, and Condition 4: eyes closed dynamic (foam) surface. The firm and dynamic surface tests assess static and dynamic balance, respectively. The conditions under which visual data are blocked are designed to detect even minor balance disturbances caused by the sensorimotor system. The sway index obtained as a result of the test represents the average position of the patient's center of mass relative to the center of the platform. Higher values indicate poorer balance. mCTSIB Condition-3, and mCTSIB Condition-4 dynamic balance assessment tests were used to assess dynamic balance. | 10th week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score | Patients' pain scores at night, at rest, and during movement were measured using visual analogue scale (VAS) (0-10 cm; 0 indicates no pain and 10 indicates severe pain). | Baseline | 
| Pain score | Patients' pain scores at night, at rest, and during movement were measured using visual analogue scale (VAS) (0-10 cm; 0 indicates no pain and 10 indicates severe pain). | 10th week | 
| Physical function | Physical function was assessed using the 30-second chair stand test (30CST) , which is recommended by the Osteoarthritis Research Society International (OARSI). Patients sit in a chair with the knees bent slightly more than 90 degrees and the feet on the floor at an angle behind the knees. While arms are crossed in front of the chest, patients stand up with lower limbs fully extended and sit back down with full contact to the chair. The movement of standing up and sitting down is counted as one cycle. The number of cycles during the 30-second period is recorded. Increasing values indicate good performance. | Baseline | 
| Physical function | Physical function was assessed using the 30-second chair stand test (30CST) , which is recommended by the Osteoarthritis Research Society International (OARSI). Patients sit in a chair with the knees bent slightly more than 90 degrees and the feet on the floor at an angle behind the knees. While arms are crossed in front of the chest, patients stand up with lower limbs fully extended and sit back down with full contact to the chair. The movement of standing up and sitting down is counted as one cycle. The number of cycles during the 30-second period is recorded. Increasing values indicate good performance | 10th week | 
| Physical function | Physical function was assessed using the 40-meter fast-paced walk test (40-m-FPWT) , which is recommended by the Osteoarthritis Research Society International (OARSI). Two cones are used to mark the start and stop lines of a 10-meter walkway. Patients are asked to walk as fast as they can along the walkway without running, and then turn around four times, and the total time recorded. Decreasing values indicate good performance | Baseline | 
| Physical function | Physical function was assessed using the 40-meter fast-paced walk test (40-m-FPWT) , which is recommended by the Osteoarthritis Research Society International (OARSI). Two cones are used to mark the start and stop lines of a 10-meter walkway. Patients are asked to walk as fast as they can along the walkway without running, and then turn around four times, and the total time recorded. Decreasing values indicate good performance | 10th week | 
| Quality of life (QoL) | QoL of patients was assessed using the QoL subscale of the Knee Injury and Osteoarthritis Outcome Score (KOOS). The KOOS consists of five subscales assessing pain, other symptoms, activities of daily living, sports and leisure time, and QoL. Each question is scored on a five-point scale ranging from 0 to 4. Scores close to 100 represent good outcomes, while scores close to 0 represent poor outcomes | Baseline | 
| Quality of life (QoL) | QoL of patients was assessed using the QoL subscale of the Knee Injury and Osteoarthritis Outcome Score (KOOS). The KOOS consists of five subscales assessing pain, other symptoms, activities of daily living, sports and leisure time, and QoL. Each question is scored on a five-point scale ranging from 0 to 4. Scores close to 100 represent good outcomes, while scores close to 0 represent poor outcomes | 10th week |