The Effect of Balance Training Using a Dynamometric Platform on Muscle Strength, Proprioception, Balance, and Gait in Patients Undergoing Total Knee Arthroplasty: A Single-Blind Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Change in average center of pressure position on the side-to-side (X) axis during eyes-open static standing (Tecnobody ProKin)
研究概览
简要总结
Total knee arthroplasty (TKA) is a common surgery used to treat advanced knee osteoarthritis, especially when other treatments no longer help. While the surgery often reduces pain and improves joint alignment, many patients still have problems with balance and movement afterward.
This study will explore whether adding balance training using the Tecnobody ProKin system to standard physical therapy helps patients recover better after TKA. The researchers will measure balance, walking ability, leg strength, and body awareness (also called proprioception) using special equipment.
The main goal is to test the hypothesis that technology-supported balance training improves recovery outcomes more effectively than standard rehabilitation alone.
详细描述
Knee osteoarthritis is a prevalent condition among older adults, often leading to pain, reduced mobility, and functional limitations. When conservative treatments fail to provide adequate relief, total knee arthroplasty (TKA) is commonly performed. Although outcomes following TKA are generally satisfactory, patients may continue to experience impairments in proprioception and balance, which can negatively affect gait and postural control.
Restoring balance and proprioceptive function is critical for optimizing functional recovery and quality of life after TKA. However, research shows that many patients fail to fully regain these abilities, even in the long term. Instrumented platforms are frequently used to objectively assess balance and proprioception, providing detailed parameters based on body sway during standing tasks.
Previous studies have evaluated the effects of balance training using systems such as Biodex in TKA patients. However, no study has yet investigated the use of the Tecnobody ProKin dynamometric platform (Bergamo, Italy) to assess and train static and dynamic balance, proprioception, muscle strength, and gait within a controlled rehabilitation framework.
This study is designed to generate scientific evidence on the effectiveness of balance training using the Tecnobody ProKin platform as an adjunct to standard rehabilitation in patients following total knee arthroplasty.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Due to the nature of the intervention, neither participants nor the primary investigator were blinded. However, outcome assessments were conducted by a blinded evaluator.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have undergone total knee arthroplasty within the past 2 years and are hospitalized at the Orthopedic Rehabilitation Clinic of Ankara Etlik City Hospital, Physical Therapy Hospital.
- •Able to fully bear weight on the operated lower extremity in the third postoperative week.
- •Willingness to participate and signing of the written informed consent form.
排除标准
- •Bilateral knee arthroplasty
- •Age under 18 years
- •Receiving treatment at a physical therapy unit within the first 2 weeks after knee arthroplasty
- •Presence of significant visual or hearing impairment, active infection
- •Clinically unstable condition
- •Presence of central nervous system lesions (e.g., stroke, multiple sclerosis)
- •Presence of malignancy
- •Presence of a fracture in the lower extremity
- •Presence of any condition that would prevent participation in the treatment
- •History of lumbar disc surgery
- •History of previous surgery in the lower extremity
- •Presence of advanced osteoarthritis in the non-operated lower extremity
结局指标
主要结局
Change in average center of pressure position on the side-to-side (X) axis during eyes-open static standing (Tecnobody ProKin)
时间窗: At baseline (pre-intervention), immediately after the 3-week intervention (post-intervention), and 6 weeks after the end of the intervention (follow-up at week 9).
Measured in millimeters (mm). Indicates the average center of pressure (CoP) position along the side-to-side (X) axis during eyes-open static standing. Deviations from the midline suggest postural asymmetry or uneven weight distribution.
Change in average center of pressure position on the forward-backward (Y) axis during eyes-open static standing (Tecnobody ProKin)
时间窗: At baseline (pre-intervention), immediately after the 3-week intervention (post-intervention), and 6 weeks after the end of the intervention (follow-up at week 9).
Measured in millimeters (mm) using the Tecnobody ProKin dynamometric platform. Indicates the average forward-backward (Y axis) position of the center of pressure (CoP) during eyes-open static standing. Deviations from neutral may reflect altered postural control or compensatory leaning in the sagittal plane.
Change in statokinesiogram path length during eyes-open standing (Tecnobody ProKin)
时间窗: At baseline (pre-intervention), immediately after the 3-week intervention (post-intervention), and 6 weeks after the end of the intervention (follow-up at week 9).
Measured in millimeters (mm) using the Tecnobody ProKin platform. Represents the total distance traveled by the center of pressure (CoP) during static standing with eyes open (also referred to as perimeter). Lower values indicate better postural control.
Change in standard deviation of center of pressure in the forward-backward direction during eyes-closed static standing (Tecnobody ProKin)
时间窗: Baseline, immediately after the 3-week intervention, and 6 weeks after the end of the intervention (follow-up at week 9)
Measured in millimeters (mm) using the Tecnobody ProKin dynamometric platform. Indicates variability in forward-backward CoP movement during eyes-closed static standing. Higher values suggest reduced postural stability and increased sway in the sagittal plane.
Change in average sway velocity in the forward-backward direction during eyes-closed static standing (Tecnobody ProKin)
时间窗: Baseline, immediately after the 3-week intervention, and 6 weeks after the end of the intervention (follow-up at week 9)
Measured in millimeters per second (mm/sec) using the Tecnobody ProKin platform. Indicates the average velocity of center of pressure (CoP) movement in the forward-backward direction during eyes-closed static standing. Lower velocities indicate improved postural control in the sagittal plane.
Change in statokinesiogram path length during eyes-closed standing (Tecnobody ProKin)
时间窗: At baseline (pre-intervention), immediately after the 3-week intervention (post-intervention), and 6 weeks after the end of the intervention (follow-up at week 9).
Measured in millimeters (mm) using the Tecnobody ProKin platform. Represents the total distance traveled by the center of pressure (CoP) during static standing with eyes closed (also referred to as perimeter). Lower values indicate better postural control.
Change in average center of pressure position on the forward-backward (Y) axis during eyes-closed static standing (Tecnobody ProKin)
时间窗: At baseline (pre-intervention), immediately after the 3-week intervention (post-intervention), and 6 weeks after the end of the intervention (follow-up at week 9).
Measured in millimeters (mm) using the Tecnobody ProKin dynamometric platform. Indicates the average forward-backward (Y axis) position of the center of pressure (CoP) during eyes-closed static standing. Deviations from neutral may reflect altered postural control or compensatory leaning in the sagittal plane.
Change in gait
时间窗: At baseline (pre-intervention), immediately after the 3-week intervention (post-intervention), and 6 weeks after the end of the intervention (follow-up at week 9).
Change in Gait will be evaluated using the Timed Up and Go (TUG) test. Participants will be timed as they rise from a chair, walk 3 meters, turn, return, and sit down. The test will be performed before and after the intervention. A decrease in time to complete the task will indicate improvement in gait speed and functional mobility.
Change in Pain Level
时间窗: At baseline (pre-intervention), immediately after the 3-week intervention (post-intervention), and 6 weeks after the end of the intervention (follow-up at week 9).
Pain intensity will be assessed using the Visual Analog Scale (VAS), a 10 cm line where 0 indicates "no pain" and 10 indicates "worst possible pain." Participants will mark their perceived knee pain level at rest and during activity. The distance from the "no pain" anchor to the mark will be measured in millimeters. A decrease in VAS score after intervention will indicate pain reduction.
Change in standard deviation of center of pressure in the medio-lateral direction during eyes-closed static standing (Tecnobody ProKin)
时间窗: Baseline, immediately after the 3-week intervention, and 6 weeks after the end of the intervention (follow-up at week 9)
Measured in millimeters (mm) using the Tecnobody ProKin dynamometric platform. Indicates variability in medio-lateral CoP movement during eyes-closed static standing. Lower values suggest more stable posture and reduced lateral sway.
Change in ellipse area of center of pressure during eyes-open standing (Tecnobody ProKin)
时间窗: At baseline (pre-intervention), immediately after the 3-week intervention (post-intervention), and 6 weeks after the end of the intervention (follow-up at week 9).
Measured in mm² using the Tecnobody ProKin platform during static standing with eyes open. The ellipse area reflects postural sway dispersion. A reduction in this area indicates improved balance control without visual input.
Change in average center of pressure position on the side-to-side (X) axis during eyes-closed static standing (Tecnobody ProKin)
时间窗: At baseline (pre-intervention), immediately after the 3-week intervention (post-intervention), and 6 weeks after the end of the intervention (follow-up at week 9).
Measured in millimeters (mm). Indicates the average center of pressure (CoP) position along the side-to-side (X) axis during eyes-closed static standing. Deviations from the midline suggest postural asymmetry or uneven weight distribution.
Change in ellipse area of center of pressure during eyes-closed standing (Tecnobody ProKin)
时间窗: At baseline (pre-intervention), immediately after the 3-week intervention (post-intervention), and 6 weeks after the end of the intervention (follow-up at week 9).
Measured in mm² using the Tecnobody ProKin platform during static standing with eyes closed. The ellipse area reflects postural sway dispersion. A reduction in this area indicates improved balance control without visual input.
Change in Proprioception
时间窗: At baseline (pre-intervention), immediately after the 3-week intervention (post-intervention), and 6 weeks after the end of the intervention (follow-up at week 9).
Change in Proprioception will be assessed using an isokinetic dynamometer. The test will measure joint position sense (JPS) at 45° knee flexion. Participants will be passively moved to the target angle 45° and then asked to actively replicate the position without visual feedback. The absolute angular error between the target and reproduced angles will be recorded pre- and post-intervention. A reduction in angular error after the training will indicate an improvement in proprioceptive accuracy.
Change in Balance Performance
时间窗: At baseline (pre-intervention), immediately after the 3-week intervention (post-intervention), and 6 weeks after the end of the intervention (follow-up at week 9).
BBS (Berg balance scale) evaluates static and dynamic balance; higher scores indicate improvement.
Change in single-leg stance time on the operated limb with eyes open
时间窗: At baseline (pre-intervention), immediately after the 3-week intervention (post-intervention), and 6 weeks after the end of the intervention (follow-up at week 9).
Balance will be assessed using the Single-Leg Stance Test. The participant is asked to stand on the operated limb with eyes open, and the time they can maintain the position without losing balance is recorded in seconds. Longer durations indicate better static balance and postural control.
Change in standard deviation of center of pressure in the medio-lateral direction during eyes-open static standing (Tecnobody ProKin)
时间窗: Baseline, immediately after the 3-week intervention, and 6 weeks after the end of the intervention (follow-up at week 9)
Measured in millimeters (mm) using the Tecnobody ProKin dynamometric platform. Indicates variability in medio-lateral CoP movement during eyes-open static standing. Lower values suggest more stable posture and reduced lateral sway.
Change in standard deviation of center of pressure in the forward-backward direction during eyes-open static standing (Tecnobody ProKin)
时间窗: Baseline, immediately after the 3-week intervention, and 6 weeks after the end of the intervention (follow-up at week 9)
Measured in millimeters (mm) using the Tecnobody ProKin dynamometric platform. Indicates variability in forward-backward CoP movement during eyes-open static standing. Higher values suggest reduced postural stability and increased sway in the sagittal plane.
Change in average sway velocity in the forward-backward direction during eyes-open static standing (Tecnobody ProKin)
时间窗: Baseline, immediately after the 3-week intervention, and 6 weeks after the end of the intervention (follow-up at week 9)
Measured in millimeters per second (mm/sec) using the Tecnobody ProKin platform. Indicates the average velocity of center of pressure (CoP) movement in the forward-backward direction during eyes-open static standing. Lower velocities indicate improved postural control in the sagittal plane.
Change in KOOS (Knee injury and Osteoarthritis Outcome Score) Total Score
时间窗: At baseline (pre-intervention), immediately after the 3-week intervention (post-intervention), and 6 weeks after the end of the intervention (follow-up at week 9).
The KOOS (Knee injury and Osteoarthritis Outcome Score) is a patient-reported questionnaire evaluating knee pain, function, and quality of life. It includes five subscales: Pain, Symptoms, Activities of Daily Living, Sport/Recreation, and QOL. The total score is the average of these subscales, ranging from 0 (worst) to 100 (best). This outcome measures the change in total KOOS score from baseline to post-intervention, with higher scores indicating improved knee health.
Change in average sway velocity in the medio-lateral direction during eyes-open static standing (Tecnobody ProKin)
时间窗: Baseline, immediately after the 3-week intervention, and 6 weeks after the end of the intervention (follow-up at week 9)
Description: Measured in millimeters per second (mm/sec) using the Tecnobody ProKin platform. Reflects the average velocity of CoP movement in the medio-lateral direction during eyes-open static standing. Reduced values suggest enhanced lateral stability and balance control.
Change in average sway velocity in the medio-lateral direction during eyes-closed static standing (Tecnobody ProKin)
时间窗: Baseline, immediately after the 3-week intervention, and 6 weeks after the end of the intervention (follow-up at week 9)
Description: Measured in millimeters per second (mm/sec) using the Tecnobody ProKin platform. Reflects the average velocity of CoP movement in the medio-lateral direction during eyes-closed static standing. Reduced values suggest enhanced lateral stability and balance control.
Change in dynamic balance performance assessed by the Angular Target Evaluation test - Right Foot (Tecnobody ProKin)
时间窗: At baseline (pre-intervention), immediately after the 3-week intervention (post-intervention), and 6 weeks after the end of the intervention (follow-up at week 9)
Assessed using the A.T.E. (Angular Target Evaluation)test on the Tecnobody ProKin platform with the right foot. This dynamic balance test measures the ability to control the center of pressure (CoP) to reach visual targets on a moving platform. Metrics include time to target, accuracy, path efficiency, and postural stability. Improved performance indicates enhanced proprioceptive control, coordination, and dynamic balance of the right lower limb.
Change in knee flexion range of motion (ROM)
时间窗: At baseline (pre-intervention), immediately after the 3-week intervention (post-intervention), and 6 weeks after the end of the intervention (follow-up at week 9)
Knee flexion range of motion (ROM) will be measured using a standard goniometer with the participant in a supine position. The angle between the thigh and lower leg during active knee flexion will be recorded in degrees. Increases in ROM indicate improved joint mobility and functional recovery after total knee arthroplasty.
Change in knee extension range of motion (ROM)
时间窗: At baseline (pre-intervention), immediately after the 3-week intervention (post-intervention), and 6 weeks after the end of the intervention (follow-up at week 9)
Knee extension range of motion (ROM) will be measured using a standard goniometer with the participant in a supine position. The angle between the thigh and lower leg during active knee extension will be recorded in degrees. Decreases in extension deficit (i.e., movement closer to full extension) indicate improved joint mobility and functional recovery following total knee arthroplasty.
Change in single-leg stance time on the operated limb with eyes closed
时间窗: At baseline (pre-intervention), immediately after the 3-week intervention (post-intervention), and 6 weeks after the end of the intervention (follow-up at week 9).
Balance will be assessed using the Single-Leg Stance Test. The participant is asked to stand on the operated limb with eyes closed, and the time they can maintain the position without losing balance is recorded in seconds. Longer durations indicate better static balance and postural control.
Change in single-leg stance time on the non-operated limb with eyes open
时间窗: At baseline (pre-intervention), immediately after the 3-week intervention (post-intervention), and 6 weeks after the end of the intervention (follow-up at week 9).
Balance will be assessed using the Single-Leg Stance Test. The participant is asked to stand on the non-operated limb with eyes open, and the time they can maintain the position without losing balance is recorded in seconds. Longer durations indicate better static balance and postural control.
Change in single-leg stance time on the non-operated limb with eyes closed
时间窗: At baseline (pre-intervention), immediately after the 3-week intervention (post-intervention), and 6 weeks after the end of the intervention (follow-up at week 9).
Balance will be assessed using the Single-Leg Stance Test. The participant is asked to stand on the non-operated limb with eyes closed, and the time they can maintain the position without losing balance is recorded in seconds. Longer durations indicate better static balance and postural control.
Change in dynamic balance performance assessed by the Angular Target Evaluation test - Left Foot (Tecnobody ProKin)
时间窗: At baseline (pre-intervention), immediately after the 3-week intervention (post-intervention), and 6 weeks after the end of the intervention (follow-up at week 9)
Assessed using the A.T.E. (Angular Target Evaluation)test on the Tecnobody ProKin platform with the left foot. This dynamic balance test measures the ability to control the center of pressure (CoP) to reach visual targets on a moving platform. Metrics include time to target, accuracy, path efficiency, and postural stability. Improved performance indicates enhanced proprioceptive control, coordination, and dynamic balance of the left lower limb.
次要结局
- Change in KOOS (Knee injury and Osteoarthritis Outcome Score) Activities of Daily Living (ADL) Subscale Score(At baseline (pre-intervention), immediately after the 3-week intervention (post-intervention), and 6 weeks after the end of the intervention (follow-up at week 9).)
- Change in KOOS (Knee injury and Osteoarthritis Outcome Score) Sport and Recreation Subscale Score(At baseline (pre-intervention), immediately after the 3-week intervention (post-intervention), and 6 weeks after the end of the intervention (follow-up at week 9).)
- Change in KOOS (Knee injury and Osteoarthritis Outcome Score) Quality of Life (QOL) Subscale Score(At baseline (pre-intervention), immediately after the 3-week intervention (post-intervention), and 6 weeks after the end of the intervention (follow-up at week 9).)
- Change in peak torque to body weight ratio of knee extensors at 60°/s(At baseline (pre-intervention), immediately after the 3-week intervention (post-intervention), and 6 weeks after the end of the intervention (follow-up at week 9).)
- Change in work per repetition of knee extensors at 60°/s(At baseline (pre-intervention), immediately after the 3-week intervention (post-intervention), and 6 weeks after the end of the intervention (follow-up at week 9))
- Change in average power per repetition of knee extensors at 60°/s(At baseline (pre-intervention), immediately after the 3-week intervention (post-intervention), and 6 weeks after the end of the intervention (follow-up at week 9))
- Change in peak torque of knee extensors at 60°/s(At baseline (pre-intervention), immediately after the 3-week intervention (post-intervention), and 6 weeks after the end of the intervention (follow-up at week 9).)
- Change in peak torque ratio of knee flexor to extensor muscles at 60°/s(At baseline (pre-intervention), immediately after the 3-week intervention (post-intervention), and 6 weeks after the end of the intervention (follow-up at week 9).)
- Change in total work of knee extensors at 180°/s(At baseline (pre-intervention), immediately after the 3-week intervention (post-intervention), and 6 weeks after the end of the intervention (follow-up at week 9))
- Change in total work of knee flexors at 180°/s(At baseline (pre-intervention), immediately after the 3-week intervention (post-intervention), and 6 weeks after the end of the intervention (follow-up at week 9))
- Change in fatigue index of knee flexors at 180°/s(At baseline (pre-intervention), immediately after the 3-week intervention (post-intervention), and 6 weeks after the end of the intervention (follow-up at week 9))
- Change in average power per repetition of knee extensors at 180°/s(At baseline (pre-intervention), immediately after the 3-week intervention (post-intervention), and 6 weeks after the end of the intervention (follow-up at week 9))
- Change in average power per repetition of knee flexors at 180°/s(At baseline (pre-intervention), immediately after the 3-week intervention (post-intervention), and 6 weeks after the end of the intervention (follow-up at week 9))
- Change in Depression Levels(At baseline (pre-intervention), immediately after the 3-week intervention (post-intervention), and 6 weeks after the end of the intervention (follow-up at week 9).)
- Change in KOOS (Knee injury and Osteoarthritis Outcome Score) Pain Subscale Score(At baseline (pre-intervention), immediately after the 3-week intervention (post-intervention), and 6 weeks after the end of the intervention (follow-up at week 9).)
- Change in KOOS (Knee injury and Osteoarthritis Outcome Score) Symptoms Subscale Score(At baseline (pre-intervention), immediately after the 3-week intervention (post-intervention), and 6 weeks after the end of the intervention (follow-up at week 9).)
- Change in peak torque of knee flexors at 180°/s(At baseline (pre-intervention), immediately after the 3-week intervention (post-intervention), and 6 weeks after the end of the intervention (follow-up at week 9).)
- Change in peak torque of knee flexors strength at 60°/s(At baseline (pre-intervention), immediately after the 3-week intervention (post-intervention), and 6 weeks after the end of the intervention (follow-up at week 9).)
- Change in peak torque to body weight ratio of knee flexor at 180°/s(At baseline (pre-intervention), immediately after the 3-week intervention (post-intervention), and 6 weeks after the end of the intervention (follow-up at week 9).)
- Change in Health-Related Quality of Life(At baseline (pre-intervention), immediately after the 3-week intervention (post-intervention), and 6 weeks after the end of the intervention (follow-up at week 9).)
- Change in Anxiety Levels(At baseline (pre-intervention), immediately after the 3-week intervention (post-intervention), and 6 weeks after the end of the intervention (follow-up at week 9).)
- Change in Kinesiophobia(At baseline (pre-intervention), immediately after the 3-week intervention (post-intervention), and 6 weeks after the end of the intervention (follow-up at week 9).)
- Change in Functional Reach Distance(At baseline (pre-intervention), immediately after the 3-week intervention (post-intervention), and 6 weeks after the end of the intervention (follow-up at week 9).)
- Change in peak torque of knee extensors at 180°/s(At baseline (pre-intervention), immediately after the 3-week intervention (post-intervention), and 6 weeks after the end of the intervention (follow-up at week 9).)
- Change in peak torque to body weight ratio of knee extensors at 180°/s(At baseline (pre-intervention), immediately after the 3-week intervention (post-intervention), and 6 weeks after the end of the intervention (follow-up at week 9).)
- Change in peak torque to body weight ratio of knee flexor at 60°/s(At baseline (pre-intervention), immediately after the 3-week intervention (post-intervention), and 6 weeks after the end of the intervention (follow-up at week 9).)
- Change in peak torque ratio of knee flexor to extensor muscles at 180°/s(At baseline (pre-intervention), immediately after the 3-week intervention (post-intervention), and 6 weeks after the end of the intervention (follow-up at week 9).)
- Change in fatigue index of knee extensors at 180°/s(At baseline (pre-intervention), immediately after the 3-week intervention (post-intervention), and 6 weeks after the end of the intervention (follow-up at week 9))
- Change in work per repetition of knee flexors at 60°/s(At baseline (pre-intervention), immediately after the 3-week intervention (post-intervention), and 6 weeks after the end of the intervention (follow-up at week 9))
- Change in average power per repetition of knee flexors at 60°/s(At baseline (pre-intervention), immediately after the 3-week intervention (post-intervention), and 6 weeks after the end of the intervention (follow-up at week 9))
研究者
Zeynep Alpoğuz Yılmaz
Principal Investigator, Medical Doctor (MD)- Specialist in Physical Medicine and Rehabilitation
Ankara Etlik City Hospital