- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07575425
Effects of Mobilized Balance Platform Exercises on Balance Parameters in Patients With Knee Osteoarthritis
Effects of Mobilized Balance Platform Exercises on Balance Parameters, Functional Status, and Pain in Patients With Knee Osteoarthritis: A Randomized Controlled Trial
This prospective single-blind randomized controlled study aims to investigate the effects of mobilized balance platform exercises on balance parameters, pain, functional status, fear of falling, and kinesiophobia in patients with knee osteoarthritis. A total of 36 patients diagnosed with knee osteoarthritis will be recruited from the outpatient clinic of Gaziler Physical Medicine and Rehabilitation Training and Research Hospital.
Participants will be randomly assigned to one of two groups. The control group will receive conventional physical therapy including transcutaneous electrical nerve stimulation (TENS) and a home exercise program consisting of knee strengthening, balance, range of motion, proprioceptive, and stretching exercises. The intervention group will receive the same conventional treatment in addition to mobilized balance platform exercises using the Huber 360 system.
Pain severity, functional status, balance parameters, fear of falling, and kinesiophobia will be evaluated before and after treatment by an assessor blinded to treatment allocation.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sefa Gumruk Aslan
- Phone Number: +903122911503
- Email: sefagumrukk@gmail.com
Study Locations
-
-
-
Ankara, Turkey (Türkiye)
- Recruiting
- Gaziler physical therapy and rehabilitation
-
Contact:
- Sefa Gumruk Aslan
- Phone Number: +903122911503
- Email: sefagumrukk@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients aged between 45 and 65 years
- Diagnosis of knee osteoarthritis classified as Kellgren-Lawrence grade 2 or 3
- Willingness to participate voluntarily in the study
Exclusion Criteria:
- Presence of orthopedic knee implants
- Kellgren-Lawrence grade 1 or grade 4 knee osteoarthritis
- Sensory impairment
- Diagnosis of malignancy
- Unhealed fractures
- Circulatory disorders
- Infection around the knee joint
- Severe hearing loss or visual impairment
- Cognitive impairment
- Uncontrolled hypertension or diabetes mellitus
- Vestibular disorders causing balance problems, such as vertigo
- Use of walking assistive devices such as canes or walkers
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Conventional Physical Therapy
Participants in this group will receive conventional physical therapy including transcutaneous electrical nerve stimulation (TENS) and a home exercise program.
The home exercise program will include knee strengthening, balance, range of motion, proprioceptive, and stretching exercises, performed 3 days per week for 20 minutes.
|
Participants will receive conventional physical therapy including transcutaneous electrical nerve stimulation (TENS) and a home exercise program consisting of knee strengthening, balance, range of motion, proprioceptive, and stretching exercises performed 3 times per week for 20 minutes.
|
|
Experimental: Mobilized Balance Platform Exercise
Participants in this group will receive conventional physical therapy including TENS in addition to mobilized balance platform exercises using the Huber 360 system.
The exercise protocol will include quadriceps and core strengthening, proprioceptive, balance, and neuromuscular exercises, performed 3 days per week for 20 minutes.
|
Participants will receive conventional physical therapy including transcutaneous electrical nerve stimulation (TENS) and a home exercise program consisting of knee strengthening, balance, range of motion, proprioceptive, and stretching exercises performed 3 times per week for 20 minutes.
Participants will perform mobilized balance platform exercises using the Huber 360 system.
The exercise protocol will include quadriceps and core strengthening, proprioceptive training, balance exercises, and neuromuscular exercises specifically designed for patients with knee osteoarthritis.
Sessions will be performed 3 times per week for 20 minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Static and Dynamic Balance Parameters
Time Frame: Before treatment and immediately after completion of the 8-week treatment program
|
Balance performance will be assessed using the Huber 360 balance assessment system.
Measurements will include static balance with eyes open and eyes closed, single-leg balance performance, and limits of stability.
|
Before treatment and immediately after completion of the 8-week treatment program
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Severity Assessed by Visual Analog Scale (VAS)
Time Frame: Before treatment and immediately after completion of the 8-week treatment program
|
Pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS) for night pain, resting pain, and pain during movement.
Higher scores indicate greater pain severity.
|
Before treatment and immediately after completion of the 8-week treatment program
|
|
Functional Status Assessed by WOMAC
Time Frame: Before treatment and immediately after completion of the 8-week treatment program
|
Functional status will be evaluated using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
Higher scores indicate worse pain, stiffness, and functional limitation.
|
Before treatment and immediately after completion of the 8-week treatment program
|
|
Functional Mobility Assessed by Timed Up and Go Test
Time Frame: Before treatment and immediately after completion of the 8-week treatment program
|
Functional mobility and dynamic balance will be assessed using the Timed Up and Go Test.
Shorter completion times indicate better functional mobility.
|
Before treatment and immediately after completion of the 8-week treatment program
|
|
Fear of Falling Assessed by the International Falls Efficacy Scale
Time Frame: Before treatment and immediately after completion of the 8-week treatment program
|
Fear of falling during activities of daily living will be evaluated using the International Falls Efficacy Scale.
Higher scores indicate greater concern about falling.
|
Before treatment and immediately after completion of the 8-week treatment program
|
|
Kinesiophobia Assessed by Tampa Scale for Kinesiophobia
Time Frame: Before treatment and immediately after completion of the 8-week treatment program
|
Fear of movement and reinjury will be evaluated using the Tampa Scale for Kinesiophobia.
Higher scores indicate greater fear of movement.
|
Before treatment and immediately after completion of the 8-week treatment program
|
Collaborators and Investigators
Investigators
- Principal Investigator: Sefa Gümrük Aslan, gaziler physcial therapy and rehabilitation hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KOA-MBP-2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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