Therapeutic Effects of Insoles on Patients With Knee Osteoarthritis
2013年1月9日 更新者:Ru-Lan Hsieh、Taipei Medical University
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
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (预期的)
90
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
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Taipei、台湾、111-01
- Shin Kong Wu Ho-Su Memorial Hospital
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
40年 至 85年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:customized insoles
customized full-length lateral wedged shoe insoles 1 month and 3 months study the immediate, short-term and intermediate-term therapeutic effects |
To study the immediate, short-term and intermediate-term therapeutic effects, including psychological function, physical activity , functional performance and quality of life, physical functional ability, pain and balance performance
其他名称:
|
|
安慰剂比较:ready made insoles
ready-made full-length lateral wedged shoe insoles at 1 and 3 months study the immediate, short-term and intermediate-term therapeutic effects |
To study the immediate, short-term and intermediate-term therapeutic effects, including psychological function, physical activity , functional performance and quality of life, physical functional ability, pain and balance performance
其他名称:
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
pain
大体时间:change from baseline at one month and three months after modified shoe insoles wearing
|
Visual analog scale, pain pressure threshold
|
change from baseline at one month and three months after modified shoe insoles wearing
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Physical functional ability
大体时间:change from baseline at one month and three months after modified shoe insoles wearing
|
10 meter normal and fast walk, up and down stairs, and 5 repeated chair-rising time
|
change from baseline at one month and three months after modified shoe insoles wearing
|
|
psychological function
大体时间:change from baseline at one month and three months after modified shoe insoles wearing
|
Hospital anxiety and depression scale, Graded chronic pain scale, Multidimensional fatigue inventory, Fear-avoidance belief questionnaire
|
change from baseline at one month and three months after modified shoe insoles wearing
|
|
functional performance
大体时间:change from baseline at one month and three months after modified shoe insoles wearing
|
Western Ontario and McMaster Universities Osteoarthritis index、Knee injury and Osteoarthritis Outcome Score
|
change from baseline at one month and three months after modified shoe insoles wearing
|
|
quality of life
大体时间:change from baseline at one month and three months after modified shoe insoles wearing
|
World Health Organization-Quality of life-Brief Vision、Osteoarthritis Quality of Life、Osteoarthritis- Knee and Hip Quality of Life
|
change from baseline at one month and three months after modified shoe insoles wearing
|
|
balance performance
大体时间:change from baseline at one month and three months after modified shoe insoles wearing
|
static postural stability and dynamic stability by Biodex Stability System, including postural stability, dynamic limits of stability and fall risk
|
change from baseline at one month and three months after modified shoe insoles wearing
|
|
physical activity
大体时间:change from baseline at one month and three months after modified shoe insoles wearing
|
CHAMPS physical activity questionnaire
|
change from baseline at one month and three months after modified shoe insoles wearing
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Ru-Lan Hsieh, MD、Shin Kong Wu Ho-Su Memorial Hospital; Taipei Medical University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2013年1月1日
初级完成 (预期的)
2013年12月1日
研究完成 (预期的)
2013年12月1日
研究注册日期
首次提交
2013年1月4日
首先提交符合 QC 标准的
2013年1月8日
首次发布 (估计)
2013年1月10日
研究记录更新
最后更新发布 (估计)
2013年1月11日
上次提交的符合 QC 标准的更新
2013年1月9日
最后验证
2013年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.