- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07568691
Comparing Whole-Body Vibration vs. Balance Board Exercise for Pain, Function, and Quality of Life in Obese Adults With Knee Osteoarthritis
April 28, 2026 updated by: Tirza Z Tamin, Indonesia University
Comparison of the Effectiveness of Balance Training Using Stochastic Resonance Therapy-Whole Body Vibration and Balanced Board in Obese Patients With Knee Osteoarthritis: A Randomized Controlled Trial
Background: Osteoarthritis (OA) is a joint disease commonly found in the knee.
Therapeutic exercise has been known as the most common therapy to treat OA, however, therapy only focuses on reducing symptoms, not on treatment of the disease which help reduce cost and improve long term quality of life.
Objective: This randomized controlled trial aim was to compare the effectiveness of Stochastic Resonance Therapy-Whole Body Vibration (SRT-WBV) vs. Balance Board (BB) training on knee pain, knee function and quality of life in obese patients with osteoarthritis.
Design: Randomized controlled trial.
Methods: Forty-four subjects diagnosed with Grade I-II Osteoarthritis Kellgren Lawrence and Grade I obesity were included, randomized to two treatment groups, the SRT-WBV (n=22) or BB (n=22) to complete a series of exercises over eight weeks.
Evaluation using the following clinical outcomes: Visual Analog Scale (VAS), Timed Up and Go test (TUG), Single leg stance (SLS) test, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Short Form 12 Health Survey Questions (SF-12).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
44
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
DKI Jakarta
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Jakarta Pusat, DKI Jakarta, Indonesia, 10430
- Universitas Indonesia, Cipto Mangunkusumo General Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 45-65 years old patient
- VAS score ranged from 4 - 6
- Diagnosed with knee OA KL Grade I - II based on American College of Rheumatology Classification
- Grade I obesity
- Understand Bahasa Indonesia
Exclusion Criteria:
- Used assistive devices or can't walk
- Diagnosed with other medical conditions or mentally unstable
- Diagnosed with advanced stage of osteoporosis
- Had history of knee surgery
- Were currently taking analgesic or anti-inflammatory medications
- Pregnant
- Unwilling to participate
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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: Stochastic Resonance Therapy-Whole Body Vibration
Subjects assigned to the SRT-WBV group were required to stand on the footboard of the SRT-WBV (SR Therapiesysteme GmbH & Co. Lifescience KG, Berlin) device with shoulder width stance, and knees bent at 30 degrees, facing forward.
The trim settings progressed from weak (45 seconds with 8 repetitions), to mild (55 seconds with 8 repetitions), average (60 seconds with 6 repetitions), and strong (60 seconds with 6 repetitions), with intensity increased at two-week intervals.
Each repetition was separated by a resting period that had the same duration as the trim settings (weak: 45 seconds, mild: 55 seconds, average and strong: 60 seconds).
|
A total of 16 therapeutic exercise sessions were conducted during the intervention where 2 sessions were conducted every week, separated by at least one day.
Specifically, subjects assigned to either group, with each session began with standardized warm-up exercises lasting approximately 5-10 minutes, followed by specific therapeutic exercises such as SRT-WBV and Balance Board.
Other Names:
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Active Comparator: Balance Board
Subjects were required to stand on the balance board with knees bent at 30 degrees and both hands placed on the chest with eyes opened.
The balance board intervention used different durations as its intensity, such as 7.5 minutes, 10 minutes, 12.5 minutes, and 15 minutes continuously without resting period.
The intensity of exercise was progressively increased every 2 weeks until completion of the program.
|
The balance board intervention used different durations as its intensity, such as 7.5 minutes, 10 minutes, 12.5 minutes, and 15 minutes continuously without resting period.
The intensity of exercise was progressively increased every 2 weeks until completion of the program.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knee function (WOMAC Total Score)
Time Frame: 8 weeks
|
Knee function was assessed using the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) questionnaire where pain score, stiffness, and physical function were evaluated on a scale of 0-4, with higher scores indicating worse pain, stiffness, and functional limitations.
The questionnaire contains 24 items and the WOMAC Osteoarthritis Index scores were then derived from the sum of the scores for the three subscales It was administered at the beginning and completion of the intervention, as well as every 4 weeks during the intervention.
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8 weeks
|
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Timed Up and Go Test (Balance)
Time Frame: 8 weeks
|
Balance and mobility will be assessed using the Timed Up and Go Test.
The time (in seconds) taken to stand up from a chair, walk 3 meters, turn, return, and sit down will be recorded.
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8 weeks
|
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Straight Leg Raise Test
Time Frame: 8 weeks
|
Balance/flexibility will be assessed using the Straight Leg Raise test.
The maximum angle (in degrees) achieved during leg elevation will be recorded.
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8 weeks
|
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Knee Pain (VAS Score)
Time Frame: 8 weeks
|
Knee pain will be measured using the Visual Analog Scale ranging from 0 to 10, with higher scores indicating greater pain.
Participants will rate their pain at rest while seated.
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8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of Life (SF-12 Score)
Time Frame: 8 weeks
|
Quality of life will be assessed using the SF-12.
Scores will be calculated according to standard scoring procedures.
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8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Tirza Z Tamin, MD, Indonesia University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2023
Primary Completion (Actual)
September 30, 2023
Study Completion (Actual)
October 15, 2023
Study Registration Dates
First Submitted
April 21, 2026
First Submitted That Met QC Criteria
April 28, 2026
First Posted (Actual)
May 6, 2026
Study Record Updates
Last Update Posted (Actual)
May 6, 2026
Last Update Submitted That Met QC Criteria
April 28, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SRTKneeOsteoarthritis
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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