Combination of Lateral Foot Orthoses and Knee Brace for Treatment of the Medial Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Change in Knee adduction moment
研究概览
简要总结
The purpose of this study is to evaluate the immediate and short-term effects of the combination of lateral customized foot orthoses on the pain and medial knee loading during gait among medial knee osteoarthritis patients. The effects of the combination is compared to the single use of these devices. The investigators recruited 22 knee osteoarthritis. They have to wear each of treatments (foot orthoses, knee brace and combination) during three months. A fifteen days wash-out period is given after each three months. Biomechanical evaluation is carried out before and after each three months. This evaluation consisted of three questionnaires (Knee Osteoarthritis Outcome Score (KOOS), Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC) and Medical Outcome Study Short Form-36( MOS-SF36)), a motion analysis with an optoelectronic system, then a 6-min walk test. During motion analysis, ten gait trials are executed without treatment and ten with the treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic medial knee OA (Kellgren-Lawrence grade I, II or III) according to clinical and radiological criteria of the American College of Rheumatology
- •Knee pain > 31/100 (Western Ontario and McMaster Universities Arthritis Index - WOMAC)
- •Moderately active
- •Varus knee alignment equal or superior to 2°
排除标准
- •Severe knee OA (K-L grade IV)
- •Rheumatoid arthritis or other inflammatory arthritis
- •Avascular necrosis
- •History of periarticular fracture or septic arthritis
- •Bone metabolic disease
- •Pigmented villonodular synovitis
- •Cartilaginous disease
- •Neuropathic arthropathy
- •Synovial osteochondromatosis
- •Total or partial knee arthroplasty
- •Flexion contracture of ipsi- or contra-lateral knee greater than 15°
- •Hip or ankle joint damage with mobility limitation
- •Obesity (BMI ≥ 40)
- •Intra-articular corticosteroids injection in the affected knee during the two previous months
- •Reduced mobility (Charnley class C)
结局指标
主要结局
Change in Knee adduction moment
时间窗: Change from Baseline at 3 months
Change in Knee pain
时间窗: Change from Baseline at 3 months
A 20-cm visual analog scale (0-100) is used to assess pain.
次要结局
- Change in Spatiotemporal gait parameters(Change from Baseline at 3 months)
- Change in Knee adduction angle(Change from Baseline at 3 months)
- Change in Comfort(Change from Baseline at 3 months)