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Recruiting NCT07080814

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

No phase Interventional Knee Osteoarthritis Total Knee Arthroplasty Recovery Postoperative Rehabilitation Balance Training

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tecnobody ProKin Balance Training, Standard rehabilitation.
Who it may be relevant to
Registry conditions: Knee Osteoarthritis, Total Knee Arthroplasty Recovery, Postoperative Rehabilitation, Balance Training. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

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

Primary outcome measures

  • 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).]
  • 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).]
  • 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).]
  • 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).]
  • 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).]
  • 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).]
  • 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).]
  • 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).]
  • 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 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).]
Secondary outcome measures (12)
  • 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).]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Ankara Etlik City Hospital — Ankara

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. PMID 29154233
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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

Identifiers

NCT: NCT07080814 · AESH-EK-2025-118

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗