Study of Various Insoles in Patients With Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- knee function questionnaire
研究概览
简要总结
It is critical to improve our understanding of knee osteoarthritis and to design better therapeutic options for this disease. The function of the knee during walking is an important factor in the development and progression of the disease. Many models of insoles that can be inserted in regular shoes with the objectives of improving the function of the knee are available on the market without prescription. Prior studies on these insoles failed to report clear benefits for the patients, mainly because the results varied strongly between persons. Walking is a complex tasks and it is well known that everybody develops his/her individual way of walking (ie., there are subtle but very important differences in the function of the knee). This observation and the fact that patient responses could vary between individuals suggest that using the same standard insoles with all patients might not be appropriated. This further suggests that care could be greatly improved if it was possible to identify patients that would respond positively to a model of insoles. Unfortunately, while several randomized controlled trials were conducted on these insoles for knee osteoarthritis, there is a paucity of data regarding their effects on the ambulatory function of the knee. Therefore, this study aims to improve the understanding regarding the effects of insoles freely available on the market in terms of knee mechanics during walking and its relation with quality of life. This study will test the hypotheses that (i) insoles have an effect on the static and dynamic lower-limb function and (ii) that benefits perceived by the patients are related to the mechanical effects produced by the insoles.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •PATIENTS WITH KNEE OSTEOARTHRITIS
- •Inclusion Criteria:
- •Knee x-ray with less than a year
- •Medial compartment knee osteoarthritis
- •Varus knee between 0 and 10 degrees
排除标准
- •Neurological impairments
- •Prior lower-limbs surgery
- •Joint injection during the last six months
- •Convergent patella
- •CONTROL SUBJECTS
- •Inclusion Criteria:
- •No lower-limbs or spine osteoarthritis
- •No pain during ambulation
- •Exclusion Criteria:
- •Neurological impairments
- •Prior lower-limbs surgery or current treatments
研究组 & 干预措施
Knee osteoarthritis
Patients with knee osteoarthritis
干预措施: insole (Other)
Control participants
Individuals without signs of knee osteoarthritis
干预措施: insole (Other)
结局指标
主要结局
knee function questionnaire
时间窗: week 18 following enrollment
次要结局
- quality of life questionnaire (EQ-5D)(Week 2, 6, 8, 12, 14 and 18 following enrollment)
研究者
Brigitte Jolles, MD
Professor
University of Lausanne Hospitals
