- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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 opdateret af: 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).
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
44
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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DKI Jakarta
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Jakarta Pusat, DKI Jakarta, Indonesien, 10430
- Universitas Indonesia, Cipto Mangunkusumo General Hospital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Aktiv komparator: 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.
Andre navne:
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Aktiv komparator: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Knee function (WOMAC Total Score)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Quality of Life (SF-12 Score)
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Tirza Z Tamin, MD, Indonesia University
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. marts 2023
Primær færdiggørelse (Faktiske)
30. september 2023
Studieafslutning (Faktiske)
15. oktober 2023
Datoer for studieregistrering
Først indsendt
21. april 2026
Først indsendt, der opfyldte QC-kriterier
28. april 2026
Først opslået (Faktiske)
6. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
6. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
28. april 2026
Sidst verificeret
1. april 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SRTKneeOsteoarthritis
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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