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

NCT07080814 | Recruiting

• 1 other identifier: AESH-EK-2025-118
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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.

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

Outcome Measures

Primary Outcomes (31)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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

  At baseline (pre-intervention), immediately after the 3-week intervention (post-intervention), and 6 weeks after the end of the intervention (follow-up at week 9).

• Change in Health-Related Quality of Life

  At baseline (pre-intervention), immediately after the 3-week intervention (post-intervention), and 6 weeks after the end of the intervention (follow-up at week 9).

• Change in Anxiety Levels

  At baseline (pre-intervention), immediately after the 3-week intervention (post-intervention), and 6 weeks after the end of the intervention (follow-up at week 9).

• Change in Kinesiophobia

  At baseline (pre-intervention), immediately after the 3-week intervention (post-intervention), and 6 weeks after the end of the intervention (follow-up at week 9).

• Change in Functional Reach Distance

  At baseline (pre-intervention), immediately after the 3-week intervention (post-intervention), and 6 weeks after the end of the intervention (follow-up at week 9).

Study Arms (2)

Balance Training Group

EXPERIMENTAL

Patients receiving standard rehabilitation plus balance training using Tecnobody ProKin platform following total knee arthroplasty.

Device: Tecnobody ProKin Balance Training; Behavioral: Standard rehabilitation

Standard Rehabilitation Group

ACTIVE COMPARATOR

Patients receiving only standard postoperative rehabilitation following total knee arthroplasty.

Behavioral: Standard rehabilitation

Interventions

Tecnobody ProKin Balance Training DEVICE

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

Balance Training Group

Standard rehabilitation BEHAVIORAL

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.

Balance Training Group; Standard Rehabilitation Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Bilateral knee arthroplasty
• Age under 18 years
• Receiving treatment at a physical therapy unit within the first 2 weeks after knee arthroplasty
• Presence of significant visual or hearing impairment, active infection
• Clinically unstable condition
• Presence of central nervous system lesions (e.g., stroke, multiple sclerosis)
• Presence of malignancy
• Presence of a fracture in the lower extremity
• Presence of any condition that would prevent participation in the treatment
• History of lumbar disc surgery
• History of previous surgery in the lower extremity
• Presence of advanced osteoarthritis in the non-operated lower extremity

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (1)

Ankara Etlik City Hospital

Ankara, Yenimahalle, 06170, Turkey (Türkiye)

RECRUITING

Related Publications (7)

• 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.

  PMID: 29154233 BACKGROUND

• Bragonzoni 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.

  PMID: 31129387 BACKGROUND

• Roig-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.

  PMID: 28252471 BACKGROUND

• Chan 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.

  PMID: 29121594 BACKGROUND

• Bakirhan 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.

  PMID: 23268822 BACKGROUND

• Ouattas 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.

  PMID: 31238189 BACKGROUND

• Dominguez-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.

  PMID: 29525292 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Zeynep Alpoğuz Yilmaz, MD

  Ankara Etlik City Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zeynep Alpoğuz Yilmaz, MD

CONTACT

+90 536 434 50 28; zeynepalpoguz@gmail.com

Başak Mansız Kaplan, Ass Prof

CONTACT

+90 535 858 21 76; basakmansiz@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the intervention, neither participants nor the primary investigator were blinded. However, outcome assessments were conducted by a blinded evaluator.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Medical Doctor (MD)- Specialist in Physical Medicine and Rehabilitation

Model Details: 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.

Study Record Dates

• First Submitted: July 6, 2025
• First Posted: July 23, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)