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临床试验/NCT01765101
NCT01765101Unknown3 期

Therapeutic Effects of Ready-made Full-length Lateral Wedged Insoles and Customized Full-length Lateral Wedged Insoles on Patients With Knee Osteoarthritis : a Double Blind, Randomized Controlled Study

Taipei Medical University2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2013年1月最近更新:
适应症

试验速览

阶段
3 期
入组人数
90
试验地点
2
主要终点
pain

研究概览

简要总结

Using double blind, randomized controlled design to study the immediate, short-term and intermediate-term therapeutic effects of ready-made full-length lateral wedged shoe insoles and customized full-length lateral wedged shoe insoles to patients with knee osteoarthritis, under the basis of International Classification Functioning, Disability and Health.

详细描述

A total of 90 patients will be collected. The participants will be randomized into two groups, including ready-made full-length lateral wedged shoe insoles group and customized full-length lateral wedged shoe insoles group. The psychological function (Hospital anxiety and depression scale, Graded chronic pain scale, Multidimensional fatigue inventory, Fear-avoidance belief questionnaire), physical activity (CHAMPS physical activity questionnaire), functional performance (Western Ontario and McMaster Universities Osteoarthritis index、Knee injury and Osteoarthritis Outcome Score) and quality of life (World Health Organization-Quality of life-Brief Vision、Osteoarthritis Quality of Life、Osteoarthritis- Knee and Hip Quality of Life) will be evaluated. Physical functional ability (10 meter normal and fast walk, up and down stairs, and 5 repeated chair-rising time), pain (Visual analog scale, pain pressure threshold ) and balance performance (static postural stability and dynamic stability by Biodex Stability System, including postural stability, dynamic limits of stability and fall risk) will be evaluated before and immediately after the ready-made full-length shoe insoles and customized full-length shoe insoles are prescribed. All the evaluations, including physical functional ability, pain, balance, psychological, physical activity, functional performance, and quality of life, will be re-evaluated at one month after and three months after modified shoe insoles wearing. Subjects and evaluator were both blinded to the group's classification during the whole course of study.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • fulfill the combined clinical and radiographic criteria for knee osteoarthritis, as established by the American College of Rheumatology
  • with Kellgren-Lawrence scores of 2 or higher in the isolated medial compartment

排除标准

  • with a history of previous knee surgery with an implant
  • reduced lateral compartment and/or combined medial and lateral compartments in knee joints were excluded
  • pregnant or planning to become pregnant
  • self-reported history of vertigo, malignancy, stroke, or other conditions that may impair vestibular function

结局指标

主要结局

pain

时间窗: change from baseline at one month and three months after modified shoe insoles wearing

Visual analog scale, pain pressure threshold

次要结局

  • Physical functional ability(change from baseline at one month and three months after modified shoe insoles wearing)
  • psychological function(change from baseline at one month and three months after modified shoe insoles wearing)
  • functional performance(change from baseline at one month and three months after modified shoe insoles wearing)
  • quality of life(change from baseline at one month and three months after modified shoe insoles wearing)
  • balance performance(change from baseline at one month and three months after modified shoe insoles wearing)
  • physical activity(change from baseline at one month and three months after modified shoe insoles wearing)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ru-Lan Hsieh

MD, Associate professor

Taipei Medical University

研究点 (2)

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