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临床试验/NCT04629040
NCT04629040Unknown不适用

The Effect of Lateral Wedge Insole for Knee Osteoarthritis Patient in Plantar Pressure, Quadriceps Thickness, Gait and Walking Speed: a Randomized Controlled Trial

China Medical University Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年11月13日最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
1
主要终点
Change from baseline in quadriceps thickness at week 4, week 8 and week 12

研究概览

简要总结

Investigators would let knee osteoarthritis patient dressing lateral wedge insole and evaluate the effect for foot pressure modification, quadriceps thickness detected with ultrasound and gait. Investigators would made the patient in control group dressing ordinary insole.

详细描述

Knee osteoarthritis is one of the most popular disease affected elderly people and made them discomfort. There was no study using foot pressure as a parameter about lateral wedge insole intervention for the knee osteoarthritis patient. The purpose of this study was to investigate the effect of lateral wedge insole for the patient of knee osteoarthritis. During total period of 12 weeks for the study, investigators randomized the patient into experimental and control group. Then investigators evaluated the patient's foot pressure, quadriceps thickness, stride length, stride width, walking speed, pain scale and daily function before intervention, 4th weeks, 8th weeks and 12th weeks. Investigators would use pressure insole designed in the Industrial Technology Research Institute in Taiwan. The portable device used in this study maybe suitable for evaluation of other lower limb disease. There were studies evaluating elderly people dysfunction, critical illness muscle atrophy or knee joint disease with ultrasound detected quadriceps thickness. But there was no study about the correlation between foot pressure and quadriceps thickness for evaluating the effect of lateral wedge insole. Investigators hoped to make a new model for evaluating lower limbs disorder in the future.

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
None

入排标准

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

入选标准

  • Knee osteoarthritis patients
  • Medial knee pain

排除标准

  • Unable to walk independently
  • Ambulation with device
  • Any neurologic disease
  • Rheumatoid arthritis, gouty arthritis
  • History of lower limbs fracture
  • History of operation for lower limbs
  • Any infectious disease

结局指标

主要结局

Change from baseline in quadriceps thickness at week 4, week 8 and week 12

时间窗: Baseline, week 4, week 8 and week 12

Investigators would use ultrasound to measure quadriceps thickness of participants at baseline, 4 weeks after dressing insole, 8 weeks after dressing insole and 12 weeks after dressing insole

Change from baseline in foot pressure at week 12

时间窗: Baseline and week 12

Investigators would use pressure insole to detect foot pressure of participants at baseline and 12 weeks after dressing insole

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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