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临床试验/NCT03843684
NCT03843684已完成不适用

Effects of 3D-printed Insoles on Lower Extremity Biomechanics and Knee Joint Loading During Walking and Stair Climbing in Individuals With Knee Osteoarthritis

National Yang Ming Chiao Tung University2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2019年4月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
2
主要终点
Knee adduction moment during level walking and stair negotiation

研究概览

简要总结

The purposes of this study are: (1) to determine the kinematics, kinetics, and muscle co-activation ratio of level walking and stair negotiation under three different conditions (shoes only, shoes embedded 3D printed insoles, and shoes embedded 5-degree lateral wedges), (2) to build a detailed patient-specific knee model via MR images and musculoskeletal model, then, evaluate the compressive forces acting on the medial aspect of the knee during level walking and stair negotiation.

详细描述

This study is a cross-sectional study with patients serving as their own control. The investigators will recruit 20 patients with knee osteoarthritis. Using motion capture system, force plates, wireless EMG to capture the motion data of patients during walking and stair negotiation in each condition.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
50 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Medial knee OA (Kellgren-Lawrence grade I, II or III) according to clinical and radiological criteria of the American College of Rheumatology
  • Aged from 50 to 70 years

排除标准

  • Neuromuscular illness (e.g., Parkinson disease, Neuropathy)
  • Predominant lateral or patella-femoral OA
  • Previous of planned hip or knee replacement
  • Hip or ankle arthritis
  • Rheumatoid arthritis
  • Unable to walk without a cane or walker
  • Unable to walk up and down the stairs

结局指标

主要结局

Knee adduction moment during level walking and stair negotiation

时间窗: 10 minutes

Surrogate marker of medial knee loading. Using motion capture system data to calculate the knee adduction moment via inverse dynamics method.

Muscle co-activation ratio during level walking and stair negotiation

时间窗: 10 minutes

Level of muscle co-activation measured by electromyography (EMG).

Medial knee joint contact force during level walking and stair negotiation

时间窗: 10 minutes

Calculate the medial knee force to identify the change in medial knee loading by musculoskeletal model. The musculoskeletal model is driven by motion capture system data.

次要结局

  • Knee flexion moment during level walking and stair negotiation(10 minutes)
  • Path of center of pressure during level walking and stair negotiation(10 minutes)
  • Lower limbs joint angles during level walking and stair negotiation(10 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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