The Effects of Knee Brace and Muscle Training on Osteoarthritis Patients
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Western Ontario and McMaster Universities Osteoarthritis Index
研究概览
简要总结
A new non-weight-bearing knee brace has been developed to correct abnormal alignment and reduce joint pressure, showing promising results in alleviating knee osteoarthritis symptoms compared to traditional braces. In addition, Blood Flow Restriction (BFR) training, which involves using pressure bands to simulate high-intensity exercise during low-intensity workouts, has been shown to enhance muscle strength.
This research will employ a randomized single-blind crossover trial to compare the effectiveness of the new and traditional braces, while also assessing BFR's impact on lower limb strength and knee function. This project will utilize various evaluation tools, including pain scales, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), participant satisfaction, muscle tension, Q-angle measurements, and joint range of motion. This project will assess the impacts of the new knee brace and BFR in alleviating pain and improving mobility.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Screening
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Volunteers over 50 years of age who are able to fully comply with the study procedures.
- •Subjects diagnosed with unilateral or bilateral knee osteoarthritis by a physician based on X-ray findings and clinical symptoms.
- •Radiographic diagnosis is evaluated using the Kellgren and Lawrence Scale (K/L grade) as the radiographic assessment tool.
- •Clinical diagnosis follows the American College of Rheumatology (ACR, 1991) criteria, which include clinical symptoms in combination with radiographic or laboratory findings.
- •The diagnostic criteria are:
- •Knee pain on most days of the past month.
- •Presence of osteophytes on X-ray.
- •Synovial fluid that is clear, viscous, and contains fewer than 2,000 white blood cells/mL.
- •Age over 50 years.
- •Morning stiffness of the knee lasting less than 30 minutes.
- •Crepitus on knee motion.
- •Diagnosis of knee osteoarthritis is confirmed when any of the following combinations are present:
排除标准
- •Individuals with general contraindications to treatment, such as severe medical conditions, recent major trauma, or pregnancy.
- •Individuals with a history of substance abuse (including excessive alcohol consumption) that could affect pain perception.
- •Individuals with local skin infections, ulcers, or lesions in the treatment area.
- •Individuals who have undergone previous knee surgery or total knee arthroplasty.
- •Individuals with central or peripheral nervous system disorders.
- •Individuals with cognitive impairment who are unable to comply with the study procedures.
- •Individuals currently receiving other treatments for knee osteoarthritis.
结局指标
主要结局
Western Ontario and McMaster Universities Osteoarthritis Index
时间窗: up to 16 weeks
Western Ontario and McMaster Universities Osteoarthritis Index
时间窗: up to 16 weeks
次要结局
未报告次要终点