Back to resultsThe Efficacy of Balance and Proprioception Exercises in Patients With Knee Osteoarthritis
Primary Purpose
Knee Osteoarthritis, Balance; Distorted, Proprioceptive Disorders
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Balance and proprioception exercises
Home exercises program
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis
Eligibility Criteria
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.
Sites / Locations
- Izmir Bozyaka Research and Training Hostpital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Biodex Training (BT) group
Classical balance training group (CT group)
Control group
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
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).
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).
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.
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
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
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
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
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
Full Information
NCT ID
NCT05287802
First Posted
March 1, 2022
Last Updated
March 10, 2022
Sponsor
Bozyaka Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05287802
Brief Title
The Efficacy of Balance and Proprioception Exercises in Patients With Knee Osteoarthritis
Official Title
The Efficacy of Balance and Proprioception Exercises in Patients With Knee Osteoarthritis: a Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
May 2014 (Actual)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bozyaka Training and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis, Balance; Distorted, Proprioceptive Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderOutcomes Assessor
Masking Description
The patients, the outcome assessor, care provider physicians, and the statistician were blinded to allocation. The supervising physician was not blinded.
Allocation
Randomized
Enrollment
89 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Biodex Training (BT) group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Classical balance training group (CT group)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Balance and proprioception exercises
Intervention Description
Balance and proprioception exercises using two different methods (classical balance training and Biodex) in addition to strengthening exercises
Intervention Type
Other
Intervention Name(s)
Home exercises program
Intervention Description
Isometric exercises for the quadriceps and hamstrings at home
Primary Outcome Measure Information:
Title
Dynamic balance
Description
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.
Time Frame
Baseline
Title
Dynamic balance
Description
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.
Time Frame
10th week
Title
Dynamic balance
Description
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.
Time Frame
Baseline
Title
Dynamic balance
Description
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.
Time Frame
10th week
Secondary Outcome Measure Information:
Title
Pain score
Description
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).
Time Frame
Baseline
Title
Pain score
Description
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).
Time Frame
10th week
Title
Physical function
Description
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.
Time Frame
Baseline
Title
Physical function
Description
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
Time Frame
10th week
Title
Physical function
Description
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
Time Frame
Baseline
Title
Physical function
Description
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
Time Frame
10th week
Title
Quality of life (QoL)
Description
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
Time Frame
Baseline
Title
Quality of life (QoL)
Description
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
Time Frame
10th week
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
BUGRA INCE, MD
Organizational Affiliation
Bozyaka Training and Research Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
ALTINAY GOKSEL KARATEPE, MD
Organizational Affiliation
University of Health Sciences Izmır Faculty, Bozyaka Training and Research Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Izmir Bozyaka Research and Training Hostpital
City
İzmir
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
upon request
Citations:
PubMed Identifier
17216685
Citation
Jordan JM, Helmick CG, Renner JB, Luta G, Dragomir AD, Woodard J, Fang F, Schwartz TA, Abbate LM, Callahan LF, Kalsbeek WD, Hochberg MC. Prevalence of knee symptoms and radiographic and symptomatic knee osteoarthritis in African Americans and Caucasians: the Johnston County Osteoarthritis Project. J Rheumatol. 2007 Jan;34(1):172-80.
Results Reference
background
PubMed Identifier
25695471
Citation
Anwer S, Alghadir A, Brismee JM. Effect of Home Exercise Program in Patients With Knee Osteoarthritis: A Systematic Review and Meta-analysis. J Geriatr Phys Ther. 2016 Jan-Mar;39(1):38-48. doi: 10.1519/JPT.0000000000000045.
Results Reference
background
PubMed Identifier
10835834
Citation
Niino N, Tsuzuku S, Ando F, Shimokata H. Frequencies and circumstances of falls in the National Institute for Longevity Sciences, Longitudinal Study of Aging (NILS-LSA). J Epidemiol. 2000 Apr;10(1 Suppl):S90-4. doi: 10.2188/jea.10.1sup_90.
Results Reference
background
PubMed Identifier
29283019
Citation
Khan SJ, Khan SS, Usman J, Mokhtar AH, Abu Osman NA. Effects of different foot progression angles and platform settings on postural stability and fall risk in healthy and medial knee osteoarthritic adults. Proc Inst Mech Eng H. 2018 Feb;232(2):163-171. doi: 10.1177/0954411917750409. Epub 2017 Dec 28.
Results Reference
background
PubMed Identifier
19480863
Citation
Jan MH, Lin CH, Lin YF, Lin JJ, Lin DH. Effects of weight-bearing versus nonweight-bearing exercise on function, walking speed, and position sense in participants with knee osteoarthritis: a randomized controlled trial. Arch Phys Med Rehabil. 2009 Jun;90(6):897-904. doi: 10.1016/j.apmr.2008.11.018.
Results Reference
background
Learn more about this trial
The Efficacy of Balance and Proprioception Exercises in Patients With Knee Osteoarthritis
We'll reach out to this number within 24 hrs