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临床试验/NCT02530684
NCT02530684已完成不适用

Study of Various Insoles in Patients With Knee Osteoarthritis

University of Lausanne Hospitals2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2014年1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
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

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

发起方
University of Lausanne Hospitals
申办方类型
Other
责任方
Principal Investigator
主要研究者

Brigitte Jolles, MD

Professor

University of Lausanne Hospitals

研究点 (2)

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