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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAnkara Etlik City Hospital

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

46 Participants
are divided into 2 treatment groups
Group A: Balance Training GroupExperimental treatment 2 interventions
Group B: Standard Rehabilitation GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

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).
2

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.

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).
3

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.

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).
4

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.

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 outcomes

1

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.

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).
2

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.

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).
3

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.

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).
4

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.

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).

Other outcomes

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