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- Klinische proef NCT07568691
Comparing Whole-Body Vibration vs. Balance Board Exercise for Pain, Function, and Quality of Life in Obese Adults With Knee Osteoarthritis
28 april 2026 bijgewerkt door: 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).
Studie Overzicht
Toestand
Voltooid
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
44
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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DKI Jakarta
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Jakarta Pusat, DKI Jakarta, Indonesië, 10430
- Universitas Indonesia, Cipto Mangunkusumo General Hospital
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Actieve vergelijker: 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).
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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.
Andere namen:
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Actieve vergelijker: 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.
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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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Knee function (WOMAC Total Score)
Tijdsspanne: 8 weeks
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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)
Tijdsspanne: 8 weeks
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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
Tijdsspanne: 8 weeks
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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)
Tijdsspanne: 8 weeks
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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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Quality of Life (SF-12 Score)
Tijdsspanne: 8 weeks
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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
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Tirza Z Tamin, MD, Indonesia University
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 maart 2023
Primaire voltooiing (Werkelijk)
30 september 2023
Studie voltooiing (Werkelijk)
15 oktober 2023
Studieregistratiedata
Eerst ingediend
21 april 2026
Eerst ingediend dat voldeed aan de QC-criteria
28 april 2026
Eerst geplaatst (Werkelijk)
6 mei 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
6 mei 2026
Laatste update ingediend die voldeed aan QC-criteria
28 april 2026
Laatst geverifieerd
1 april 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- SRTKneeOsteoarthritis
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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