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

NCT ID: NCT07080814

Last Updated: 2025-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-01

Study Completion Date

2027-05-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Knee Osteoarthritis Total Knee Arthroplasty Recovery Postoperative Rehabilitation Balance Training

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Due to the nature of the intervention, neither participants nor the primary investigator were blinded. However, outcome assessments were conducted by a blinded evaluator.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Balance Training Group

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

Group Type EXPERIMENTAL

Tecnobody ProKin Balance Training

Intervention Type DEVICE

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

Standard rehabilitation

Intervention Type 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.

Standard Rehabilitation Group

Patients receiving only standard postoperative rehabilitation following total knee arthroplasty.

Group Type ACTIVE_COMPARATOR

Standard rehabilitation

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tecnobody ProKin Balance Training

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

Intervention Type DEVICE

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ankara Etlik City Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Zeynep Alpoğuz Yılmaz

Principal Investigator, Medical Doctor (MD)- Specialist in Physical Medicine and Rehabilitation

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Zeynep Alpoğuz Yilmaz, MD

Role: PRINCIPAL_INVESTIGATOR

Ankara Etlik City Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ankara Etlik City Hospital

Ankara, Yenimahalle, Turkey (Türkiye)

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Zeynep Alpoğuz Yilmaz, MD

Role: CONTACT

+90 536 434 50 28

Başak Mansız Kaplan, Ass Prof

Role: CONTACT

+90 535 858 21 76

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Zeynep Alpoğuz Yilmaz, MD

Role: primary

00 90 536 434 50 28

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 31238189 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29525292 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29154233 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31129387 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28252471 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29121594 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23268822 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AESH-EK-2025-118

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Return to Activity After Total Knee Arthroplasty
NCT07006545 ENROLLING_BY_INVITATION
Knee Arthroplasty Activity Trial
NCT04107649 ACTIVE_NOT_RECRUITING NA