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临床试验/NCT07568691
NCT07568691已完成不适用

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

Indonesia University1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2023年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
44
试验地点
1
主要终点
Knee function (WOMAC Total Score)

研究概览

简要总结

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
45 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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
  • Unwilling to participate

研究组 & 干预措施

Stochastic Resonance Therapy-Whole Body Vibration

Active Comparator

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).

干预措施: Stochastic Resonance Therapy-Whole Body Vibration (Device)

Balance Board

Active Comparator

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.

干预措施: Balance Board (Device)

结局指标

主要结局

Knee function (WOMAC Total Score)

时间窗: 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.

Timed Up and Go Test (Balance)

时间窗: 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.

Straight Leg Raise Test

时间窗: 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.

Knee Pain (VAS Score)

时间窗: 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.

次要结局

  • Quality of Life (SF-12 Score)(8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tirza Z Tamin

Principal Investigator

Indonesia University

研究点 (1)

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