Knee OsteoarthritisNCT07080814
The Effect of Balance Training Using a Dynamometric Platform in Patients Undergoing Total Knee Arthroplasty
A study testing Tecnobody ProKin Balance Training and Standard rehabilitation in people with Knee Osteoarthritis and Total Knee Arthroplasty Recovery, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis, Total Knee Arthroplasty Recovery, Postoperative Rehabilitation
- What is being tested?
- Tecnobody ProKin Balance Training and Standard rehabilitation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2025to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Etlik City Hospital
Ankara, Yenimahalle, 06170
Zeynep Alpoğuz Yilmaz, MD, 00 90 536 434 50 28, zeynepalpoguz@gmail.com
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- Knee Osteoarthritis, Total Knee Arthroplasty Recovery, Postoperative Rehabilitation, Balance Training
- Being tested
- Tecnobody ProKin Balance Training, Standard rehabilitation
- Keywords
- Total Knee Arthroplasty, Muscle Strength, Proprioception, Gait, balance training, Static Balance, Dynamic Balance
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tecnobody ProKin Balance TrainingDevice
Balance training using Tecnobody ProKin dynamometric platform, administered 5 sessions per week for 3 weeks in addition to standard rehabilitation.
Standard rehabilitationBehavioural
The standard rehabilitation protocol includes cold pack application to the knee region, transcutaneous electrical nerve stimulation (TENS), quadriceps muscle stimulation, knee stretching, active-assisted and active range of motion (ROM) exercises, strengthening exercises for the knee extensors and hip abductors/extensors, gait training, and balance exercises. Each patient will undergo a total of 15 physical therapy sessions.
| Study group | Role | What they receive |
|---|---|---|
| Balance Training Group | Experimental | Patients receiving standard rehabilitation plus balance training using Tecnobody ProKin platform following total knee arthroplasty. Receives: Device: Tecnobody ProKin Balance Training; Behavioral: Standard rehabilitation |
| Standard Rehabilitation Group | Active comparator | Patients receiving only standard postoperative rehabilitation following total knee arthroplasty. Receives: Behavioral: Standard rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in statokinesiogram path length during eyes-open standing (Tecnobody ProKin)
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.
Measured: 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 statokinesiogram path length during eyes-closed standing (Tecnobody ProKin)
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.
Measured: 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 ellipse area of center of pressure during eyes-open standing (Tecnobody ProKin)
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.
Measured: 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 ellipse area of center of pressure during eyes-closed standing (Tecnobody ProKin)
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.
Measured: 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 center of pressure position on the side-to-side (X) axis during eyes-open static standing (Tecnobody ProKin)
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.
Measured: 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 center of pressure position on the forward-backward (Y) axis during eyes-open static standing (Tecnobody ProKin)
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.
Measured: 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 center of pressure position on the side-to-side (X) axis during eyes-closed static standing (Tecnobody ProKin)
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.
Measured: 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 center of pressure position on the forward-backward (Y) axis during eyes-closed static standing (Tecnobody ProKin)
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.
Measured: 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
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.
Measured: 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) Total Score
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.
Measured: 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
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.
Measured: 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 Pain Level
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.
Measured: 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 Balance Performance
BBS (Berg balance scale) evaluates static and dynamic balance; higher scores indicate improvement.
Measured: 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 single-leg stance time on the operated limb with eyes open
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.
Measured: 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 center of pressure position on the forward-backward (Y) axis during eyes-open static standing (Tecnobody ProKin)
Measured in millimeters (mm) using the Tecnobody ProKin dynamometric platform.. Indicates the average center of pressure (CoP) position along the axis during eyes-open static standing. Deviations from neutral suggest compensatory leaning or altered sagittal balance.
Measured: 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 center of pressure position on the side-to-side (X) axis during eyes-open static standing (Tecnobody ProKin)
Measured in millimeters (mm) using the Tecnobody ProKin dynamometric platform.. 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.
Measured: 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 standard deviation of center of pressure in the medio-lateral direction during eyes-open static standing (Tecnobody ProKin)
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.
Measured: Baseline, immediately after the 3-week intervention, and 6 weeks after the end of the intervention (follow-up at week 9)
Change in standard deviation of center of pressure in the medio-lateral direction during eyes-closed static standing (Tecnobody ProKin)
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.
Measured: Baseline, immediately after the 3-week intervention, and 6 weeks after the end of the intervention (follow-up at week 9)
Change in standard deviation of center of pressure in the forward-backward direction during eyes-open static standing (Tecnobody ProKin)
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.
Measured: Baseline, immediately after the 3-week intervention, and 6 weeks after the end of the intervention (follow-up at week 9)
Change in standard deviation of center of pressure in the forward-backward direction during eyes-closed static standing (Tecnobody ProKin)
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.
Measured: Baseline, immediately after the 3-week intervention, and 6 weeks after the end of the intervention (follow-up at week 9)
Change in average sway velocity in the forward-backward direction during eyes-open static standing (Tecnobody ProKin)
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.
Measured: Baseline, immediately after the 3-week intervention, and 6 weeks after the end of the intervention (follow-up at week 9)
Change in average sway velocity in the forward-backward direction during eyes-closed static standing (Tecnobody ProKin)
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.
Measured: Baseline, immediately after the 3-week intervention, and 6 weeks after the end of the intervention (follow-up at week 9)
Change in average sway velocity in the medio-lateral direction during eyes-open static standing (Tecnobody ProKin)
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.
Measured: Baseline, immediately after the 3-week intervention, and 6 weeks after the end of the intervention (follow-up at week 9)
Change in average sway velocity in the medio-lateral direction during eyes-closed static standing (Tecnobody ProKin)
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.
Measured: Baseline, immediately after the 3-week intervention, and 6 weeks after the end of the intervention (follow-up at week 9)
Change in dynamic balance performance assessed by the Angular Target Evaluation test - Right Foot (Tecnobody ProKin)
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.
Measured: 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 knee flexion range of motion (ROM)
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.
Measured: 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 knee extension range of motion (ROM)
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.
Measured: 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 single-leg stance time on the operated limb with eyes closed
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.
Measured: 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 single-leg stance time on the non-operated limb with eyes open
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.
Measured: 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 single-leg stance time on the non-operated limb with eyes closed
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.
Measured: 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 dynamic balance performance assessed by the Angular Target Evaluation test - Left Foot (Tecnobody ProKin)
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.
Measured: 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)
Secondary outcomes (30)
Change in KOOS (Knee injury and Osteoarthritis Outcome Score) Pain Subscale Score
The KOOS (Knee injury and Osteoarthritis Outcome Score) Pain subscale will be used to evaluate knee-related pain. Scores range from 0 (extreme problems) to 100 (no problems), with higher scores indicating better outcomes.
Measured: 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
The 12-Item Short Form Health Survey (SF-12) is a patient-reported measure evaluating physical and mental components of health-related quality of life. Scores range from 0 to 100, with higher scores indicating better health status.
Measured: 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
The Hospital Anxiety and Depression Scale - Anxiety subscale (HADS-A) is a validated tool specifically designed to assess symptoms of anxiety in hospital settings. It includes 7 items, each scored from 0 to 3, yielding a total score ranging from 0 to 21. Lower scores indicate fewer anxiety symptoms, while higher scores reflect greater levels of anxiety.
Measured: 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
The Tampa Scale for Kinesiophobia (TSK) is a questionnaire that measures fear of movement or re-injury. Scores range from 17 to 68, with higher scores indicating greater fear.
Measured: 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
The Functional Reach Test (FRT) is a clinical measure used to assess dynamic balance and stability. It quantifies the maximum distance an individual can reach forward beyond arm's length while standing in a fixed position without losing balance. The outcome is measured in centimeters. An increase in reach distance from baseline to post-intervention indicates improvement in dynamic balance and postural control.
Measured: 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
The KOOS Symptoms subscale assesses joint stiffness, swelling, and mechanical symptoms in the knee. Scores range from 0 (extreme problems) to 100 (no problems), with higher scores indicating better knee function.
Measured: 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) Activities of Daily Living (ADL) Subscale Score
This subscale evaluates difficulty with performing daily activities such as walking, climbing stairs, and standing. Scores range from 0 to 100, where higher scores reflect better functional ability in daily life.
Measured: 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
This subscale measures the participant's ability to perform sport and recreational activities such as squatting, running, and jumping. Scores range from 0 (severe difficulty) to 100 (no difficulty).
Measured: 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
This subscale captures the impact of knee problems on the participant's overall quality of life, including mental and social aspects. Scores range from 0 (very poor knee-related QOL) to 100 (no impact). Change in scores will indicate perceived recovery and satisfaction.
Measured: 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
Assessed using an isokinetic dynamometer (Computer Sports Medicine Inc., Stoughton, MA, USA). Peak torque represents the maximum torque output of the knee extensor muscles during concentric contraction at an angular velocity of 180 degrees per second. Higher values indicate greater muscle strength.
Measured: 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
Assessed using an isokinetic dynamometer (Computer Sports Medicine Inc., Stoughton, MA, USA). Peak torque represents the maximum torque output of the knee extensor muscles during concentric contraction at an angular velocity of 60 degrees per second. Higher values indicate greater muscle strength.
Measured: 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
Assessed using an isokinetic dynamometer (Computer Sports Medicine Inc., Stoughton, MA, USA). Peak torque represents the maximum torque output of the knee flexor muscles during concentric contraction at an angular velocity of 180 degrees per second. Higher values indicate greater muscle strength.
Measured: 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
Assessed using an isokinetic dynamometer (Computer Sports Medicine Inc., Stoughton, MA, USA). Peak torque represents the maximum torque output of the knee flexor muscles during concentric contraction at an angular velocity of 60 degrees per second. Higher values indicate greater muscle strength.
Measured: 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
Measured using an isokinetic dynamometer at 180°/s. This parameter expresses peak torque of the knee extensors relative to body weight (%), allowing comparison across individuals and limbs. Higher values indicate improved relative muscle strength.
Measured: 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
Measured using an isokinetic dynamometer at 60°/s. This parameter expresses peak torque of the knee extensors relative to body weight (%), allowing comparison across individuals and limbs. Higher values indicate improved relative muscle strength.
Measured: 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
Measured using an isokinetic dynamometer at an angular velocity of 180°/s. This parameter expresses peak torque of the knee flexors relative to body weight (%), allowing comparison across individuals and limbs. Higher values indicate improved relative muscle strength.
Measured: 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
Measured using an isokinetic dynamometer at 60°/s. This parameter expresses peak torque of the knee flexors relative to body weight (%), allowing comparison across individuals and limbs. Higher values indicate improved relative muscle strength.
Measured: 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
Measured using an isokinetic dynamometer. This outcome reflects the agonist/antagonist strength balance between the knee flexor (hamstring) and extensor (quadriceps) muscles. The ratio is calculated by dividing peak torque of the flexors by that of the extensors, measured at 60°/s. Balanced ratios are important for joint stability and injury prevention.
Measured: 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
Measured using an isokinetic dynamometer. This outcome reflects the agonist/antagonist strength balance between the knee flexor (hamstring) and extensor (quadriceps) muscles. The ratio is calculated by dividing peak torque of the flexors by that of the extensors, measured at 180°/s. Balanced ratios are important for joint stability and injury prevention.
Measured: 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
Total work will be assessed using an isokinetic dynamometer at an angular velocity of 180 degrees per second. It represents the cumulative torque generated by the knee extensor muscles across all repetitions during the test. Higher values indicate improved muscular endurance and sustained force production at higher speeds of movement.
Measured: 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
Total work will be assessed using an isokinetic dynamometer at an angular velocity of 180 degrees per second. It represents the cumulative torque generated by the knee flexor muscles across all repetitions during the test. Higher values indicate improved muscular endurance and sustained force production at higher speeds of movement.
Measured: 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
Fatigue index will be assessed using an isokinetic dynamometer at an angular velocity of 180 degrees per second. It reflects the percentage decline in torque output across repeated maximal knee extension contractions. A lower fatigue index indicates improved muscular endurance and greater resistance to fatigue under high-speed loading conditions.
Measured: 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
Fatigue index will be assessed using an isokinetic dynamometer at an angular velocity of 180 degrees per second. It reflects the percentage decline in torque output across repeated maximal knee flexion contractions. A lower fatigue index indicates improved muscular endurance and greater resistance to fatigue under high-speed loading conditions.
Measured: 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
Work per repetition will be assessed using an isokinetic dynamometer at an angular velocity of 60 degrees per second. This parameter represents the mechanical work produced by the knee extensor muscles during each repetition of concentric contraction. It is calculated as the area under the torque-angle curve for a single repetition. Higher values indicate improved muscular performance and efficiency during isolated strength testing.
Measured: 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
Work per repetition will be assessed using an isokinetic dynamometer at an angular velocity of 60 degrees per second. This parameter represents the mechanical work produced by the knee flexor muscles during each repetition of concentric contraction. It is calculated as the area under the torque-angle curve for a single repetition. Higher values indicate improved muscular performance and efficiency during isolated strength testing.
Measured: 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
Average power per repetition will be measured using an isokinetic dynamometer at 60 degrees per second. It is calculated by dividing the work performed during each repetition by the time taken to complete that repetition. This parameter reflects the ability of the knee extensor muscles to generate force quickly and efficiently. Increased values are associated with enhanced functional performance in tasks requiring speed and strength, such as gait and balance.
Measured: 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
Average power per repetition will be measured using an isokinetic dynamometer at 60 degrees per second. It is calculated by dividing the work performed during each repetition by the time taken to complete that repetition. This parameter reflects the ability of the knee flexor muscles to generate force quickly and efficiently. Increased values are associated with enhanced functional performance in tasks requiring speed and strength, such as gait and balance.
Measured: 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
Average power per repetition will be measured using an isokinetic dynamometer at 180 degrees per second. It is calculated by dividing the work performed during each repetition by the time taken to complete that repetition. This parameter reflects the ability of the knee extensor muscles to generate force quickly and efficiently. Increased values are associated with enhanced functional performance in tasks requiring speed and strength, such as gait and balance.
Measured: 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
Average power per repetition will be measured using an isokinetic dynamometer at 180 degrees per second. It is calculated by dividing the work performed during each repetition by the time taken to complete that repetition. This parameter reflects the ability of the knee flexor muscles to generate force quickly and efficiently. Increased values are associated with enhanced functional performance in tasks requiring speed and strength, such as gait and balance.
Measured: 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
The Hospital Anxiety and Depression Scale - Depression subscale (HADS-D) is a validated tool specifically designed to assess symptoms of depression in hospital settings. It consists of 7 items, each scored from 0 to 3, resulting in a total score ranging from 0 to 21. Lower scores indicate fewer depressive symptoms, while higher scores suggest greater levels of depression.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start1 May 2025
- Primary completion1 Feb 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to one of two groups in a parallel manner. The control group receives standard rehabilitation, while the intervention group receives additional balance training using the Tecnobody dynamometric platform (Bergamo, Italy) alongside standard care.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Zeynep Alpoğuz Yılmaz, Ankara Etlik City Hospital
- Investigators
- Zeynep Alpoğuz Yilmaz, MD, Principal investigator, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07080814
- Sponsor's protocol ID
- AESH-EK-2025-118
- Status last verified
- Jul 2025
- First submitted
- 6 Jul 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hadamus A, Bialoszewski D. Objective Assessment of Knee Proprioception and Sensorimotor Function in Patients with Primary Gonarthrosis before and after Knee Replacement. Ortop Traumatol Rehabil. 2017 Oct 31;19(5):403-414. doi: 10.5604/01.3001.0010.5820.
PubMed 29154233Bragonzoni L, Rovini E, Barone G, Cavallo F, Zaffagnini S, Benedetti MG. How proprioception changes before and after total knee arthroplasty: A systematic review. Gait Posture. 2019 Jul;72:1-11. doi: 10.1016/j.gaitpost.2019.05.005. Epub 2019 May 17.
PubMed 31129387Roig-Casasus S, Blasco JM, Lopez-Bueno L, Blasco-Igual MC. Balance Training With a Dynamometric Platform Following Total Knee Replacement: A Randomized Controlled Trial. J Geriatr Phys Ther. 2018 Oct/Dec;41(4):204-209. doi: 10.1519/JPT.0000000000000121.
PubMed 28252471Chan ACM, Ouyang XH, Jehu DAM, Chung RCK, Pang MYC. Recovery of balance function among individuals with total knee arthroplasty: Comparison of responsiveness among four balance tests. Gait Posture. 2018 Jan;59:267-271. doi: 10.1016/j.gaitpost.2017.10.020. Epub 2017 Oct 16.
PubMed 29121594Bakirhan S, Angin S, Karatosun V, Unver B, Gunal I. Physical performance parameters during standing up in patients with unilateral and bilateral total knee arthroplasty. Acta Orthop Traumatol Turc. 2012;46(5):367-72. doi: 10.3944/aott.2012.2684.
PubMed 23268822Ouattas A, Wellsandt E, Hunt NH, Boese CK, Knarr BA. Comparing single and multi-joint methods to detect knee joint proprioception deficits post primary unilateral total knee arthroplasty. Clin Biomech (Bristol). 2019 Aug;68:197-204. doi: 10.1016/j.clinbiomech.2019.06.006. Epub 2019 Jun 14.
PubMed 31238189Dominguez-Navarro F, Igual-Camacho C, Silvestre-Munoz A, Roig-Casasus S, Blasco JM. Effects of balance and proprioceptive training on total hip and knee replacement rehabilitation: A systematic review and meta-analysis. Gait Posture. 2018 May;62:68-74. doi: 10.1016/j.gaitpost.2018.03.003. Epub 2018 Mar 5.
PubMed 29525292
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07080814
- Acronym / sponsor ID
- AESH-EK-2025-118
- Conditions
- Knee Osteoarthritis, Total Knee Arthroplasty Recovery, Postoperative Rehabilitation, Balance Training
- Keywords
- Total Knee Arthroplasty, Muscle Strength, Proprioception, Gait, balance training, Static Balance, Dynamic Balance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 23 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to one of two groups in a parallel manner. The control group receives standard rehabilitation, while the intervention group receives additional balance training using the Tecnobody dynamometric platform (Bergamo, Italy) alongside standard care.
| Arm | Type | Receives |
|---|---|---|
| Balance Training Group | Experimental | Device: Tecnobody ProKin Balance Training, Behavioral: Standard rehabilitationPatients receiving standard rehabilitation plus balance training using Tecnobody ProKin platform following total knee arthroplasty. |
| Standard Rehabilitation Group | Active comparator | Behavioral: Standard rehabilitationPatients receiving only standard postoperative rehabilitation following total knee arthroplasty. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tecnobody ProKin Balance TrainingBalance training using Tecnobody ProKin dynamometric platform, administered 5 sessions per week for 3 weeks in addition to standard rehabilitation. | Device | Balance Training Group |
| Standard rehabilitationThe standard rehabilitation protocol includes cold pack application to the knee region, transcutaneous electrical nerve stimulation (TENS), quadriceps muscle stimulation, knee stretching, active-assisted and active range of motion (ROM) exercises, strengthening exercises for the knee extensors and hip abductors/extensors, gait training, and balance exercises. Each patient will undergo a total of 15 physical therapy sessions. | Behavioural | Balance Training Group, Standard Rehabilitation Group |
Primary outcome
Change in statokinesiogram path length during eyes-open standing (Tecnobody ProKin)
Time frame: 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 statokinesiogram path length during eyes-closed standing (Tecnobody ProKin)
Time frame: 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 ellipse area of center of pressure during eyes-open standing (Tecnobody ProKin)
Time frame: 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 ellipse area of center of pressure during eyes-closed standing (Tecnobody ProKin)
Time frame: 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 average center of pressure position on the side-to-side (X) axis during eyes-open static standing (Tecnobody ProKin)
Time frame: 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)
Time frame: 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 average center of pressure position on the side-to-side (X) axis during eyes-closed static standing (Tecnobody ProKin)
Time frame: 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 average center of pressure position on the forward-backward (Y) axis during eyes-closed static standing (Tecnobody ProKin)
Time frame: 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 Proprioception
Time frame: 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 KOOS (Knee injury and Osteoarthritis Outcome Score) Total Score
Time frame: 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 gait
Time frame: 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
Time frame: 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 Balance Performance
Time frame: 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
Time frame: 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 average center of pressure position on the forward-backward (Y) axis during eyes-open static standing (Tecnobody ProKin)
Time frame: 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 center of pressure (CoP) position along the axis during eyes-open static standing. Deviations from neutral suggest compensatory leaning or altered sagittal balance.
Change in average center of pressure position on the side-to-side (X) axis during eyes-open static standing (Tecnobody ProKin)
Time frame: 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 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 standard deviation of center of pressure in the medio-lateral direction during eyes-open static standing (Tecnobody ProKin)
Time frame: 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 medio-lateral direction during eyes-closed static standing (Tecnobody ProKin)
Time frame: 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 standard deviation of center of pressure in the forward-backward direction during eyes-open static standing (Tecnobody ProKin)
Time frame: 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 standard deviation of center of pressure in the forward-backward direction during eyes-closed static standing (Tecnobody ProKin)
Time frame: 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-open static standing (Tecnobody ProKin)
Time frame: 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 average sway velocity in the forward-backward direction during eyes-closed static standing (Tecnobody ProKin)
Time frame: 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 average sway velocity in the medio-lateral direction during eyes-open static standing (Tecnobody ProKin)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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.
30 secondary outcomes
Change in KOOS (Knee injury and Osteoarthritis Outcome Score) Pain Subscale Score
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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) Activities of Daily Living (ADL) Subscale Score
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Results publication: PubMed 29154233Hadamus A, Bialoszewski D. Objective Assessment of Knee Proprioception and Sensorimotor Function in Patients with Primary Gonarthrosis before and after Knee Replacement. Ortop Traumatol Rehabil. 2017 Oct 31;19(5):403-414. doi: 10.5604/01.3001.0010.5820.
- Results publication: PubMed 31129387Bragonzoni L, Rovini E, Barone G, Cavallo F, Zaffagnini S, Benedetti MG. How proprioception changes before and after total knee arthroplasty: A systematic review. Gait Posture. 2019 Jul;72:1-11. doi: 10.1016/j.gaitpost.2019.05.005. Epub 2019 May 17.
- Results publication: PubMed 28252471Roig-Casasus S, Blasco JM, Lopez-Bueno L, Blasco-Igual MC. Balance Training With a Dynamometric Platform Following Total Knee Replacement: A Randomized Controlled Trial. J Geriatr Phys Ther. 2018 Oct/Dec;41(4):204-209. doi: 10.1519/JPT.0000000000000121.
- Results publication: PubMed 29121594Chan ACM, Ouyang XH, Jehu DAM, Chung RCK, Pang MYC. Recovery of balance function among individuals with total knee arthroplasty: Comparison of responsiveness among four balance tests. Gait Posture. 2018 Jan;59:267-271. doi: 10.1016/j.gaitpost.2017.10.020. Epub 2017 Oct 16.
- Results publication: PubMed 23268822Bakirhan S, Angin S, Karatosun V, Unver B, Gunal I. Physical performance parameters during standing up in patients with unilateral and bilateral total knee arthroplasty. Acta Orthop Traumatol Turc. 2012;46(5):367-72. doi: 10.3944/aott.2012.2684.
- Results publication: PubMed 31238189Ouattas A, Wellsandt E, Hunt NH, Boese CK, Knarr BA. Comparing single and multi-joint methods to detect knee joint proprioception deficits post primary unilateral total knee arthroplasty. Clin Biomech (Bristol). 2019 Aug;68:197-204. doi: 10.1016/j.clinbiomech.2019.06.006. Epub 2019 Jun 14.
- Results publication: PubMed 29525292Dominguez-Navarro F, Igual-Camacho C, Silvestre-Munoz A, Roig-Casasus S, Blasco JM. Effects of balance and proprioceptive training on total hip and knee replacement rehabilitation: A systematic review and meta-analysis. Gait Posture. 2018 May;62:68-74. doi: 10.1016/j.gaitpost.2018.03.003. Epub 2018 Mar 5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zeynep Alpoğuz Yilmaz, MD principal investigator
Ankara Etlik City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tecnobody ProKin Balance Training and Standard rehabilitation in people with Knee Osteoarthritis and Total Knee Arthroplasty Recovery, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zeynep Alpoğuz Yilmaz, MD (+90 536 434 50 28, zeynepalpoguz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in statokinesiogram path length during eyes-open standing (Tecnobody ProKin) (time frame: 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 study lists 31 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07080814, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.