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Completed

NCT Number: NCT05287802

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

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).

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Key information

Conditions

Knee Osteoarthritis Arthritis Balance; Distorted Joint Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Osteoarthritis Osteoarthritis, Knee Pathological Conditions, Signs and Symptoms Proprioceptive Disorders Rheumatic Diseases Sensation Disorders Signs and Symptoms Somatosensory Disorders

Age range

40 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Izmir Bozyaka Research and Training Hostpital

Izmir, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Balance and proprioception exercises

Other

Balance and proprioception exercises using two different methods (classical balance training and Biodex) in addition to strengthening exercises

home exercises program

Other

Isometric exercises for the quadriceps and hamstrings at home

Primary outcomes

  1. Dynamic balance

    Time frame: Baseline

    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.

  2. Dynamic balance

    Time frame: 10th week

    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.

  3. Dynamic balance

    Time frame: Baseline

    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.

  4. Dynamic balance

    Time frame: 10th week

    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.

Secondary outcomes

  1. Pain score

    Time frame: Baseline

    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).

  2. Pain score

    Time frame: 10th week

    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).

  3. Physical function

    Time frame: Baseline

    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.

  4. Physical function

    Time frame: 10th week

    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

  5. Physical function

    Time frame: Baseline

    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

  6. Physical function

    Time frame: 10th week

    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

  7. Quality of life (QoL)

    Time frame: Baseline

    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

  8. Quality of life (QoL)

    Time frame: 10th week

    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

Sponsors and collaborators

Lead sponsor

Bozyaka Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Mar 18, 2022
Registry last updated
Mar 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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