The Effect of Balance Training Using a Dynamometric Platform in Patients Undergoing Total Knee Arthroplasty

Condition(s) studied

Investigational drug(s) / intervention(s)

Tecnobody ProKin Balance Training: Balance training using Tecnobody ProKin dynamometric platform, administered 5 sessions per week for 3 weeks in addition to standard rehabilitation.

Standard rehabilitation: 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 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.

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.

Eligibility

Primary outcome measure(s)

• Change in statokinesiogram path length during eyes-open standing (Tecnobody ProKin) — 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) — 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) — 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) — 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) — 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) — 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) — 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) — 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 — 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 — 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 — 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 — 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 — 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 — 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) — 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) — 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) — 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) — 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) — 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) — 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) — 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) — 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) — 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) — 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) — 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) — 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) — 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 — 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 — 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 — 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) — 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.

Trial sites (1)

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