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Knee Stability Training for Knee Osteoarthritis (OA)

2013年1月23日 更新者:University of Pittsburgh

Knee Stability Training in Individuals With Knee Osteoarthritis

People with knee osteoarthritis (OA) frequently complain of knee instability. This study will test whether certain exercises can improve knee stability, reduce pain, and improve physical function in people with knee OA.

Study hypotheses: 1) Participants in the stability training group will demonstrate less pain and higher levels of physical function, based on self-report measures of pain and function (WOMAC, Lower Extremity Function Scale), and less time to complete the Get Up and Go test, a physical performance measure of function. 2) During walking and the step down task, participants in the stability training group will demonstrate greater knee motion during weight bearing, greater vertical ground reaction forces and loading rates, and reduced ratios of co-contraction between quadriceps/hamsting and tibialis anterior/gastrocnemius muscle pairs compared to the standard group. Participants in the stability group will also demonstrate greater step lengths, single limb support times, and average walking velocity compared to the standard group.

研究概览

详细说明

Traditional exercise therapy for knee OA primarily focuses on lower limb strength and joint motion deficits. Recent evidence has suggested that changes in lower limb biomechanical factors during weight bearing activities may have substantial impact on physical function and disease progression in individuals with knee OA. The effectiveness of exercise therapy programs might be improved by incorporating balance and agility training techniques (knee stability training). The aim of this trial is to test the effectiveness of supplementing traditional exercise therapy with knee stability training techniques tailored for individuals with knee OA.

Participants will be randomly assigned to one of two groups. The first group will participate in a standard rehabilitation program of traditional exercise therapy for knee OA. The second group will participate in a standard rehabilitation program supplemented with a knee stability program. Study visits will occur at study entry, 2 months, 6 months, and 1 year. At each study visit, changes in pain, physical function, and biomechanical factors will be assessed. This study will last for one year.

研究类型

介入性

注册 (实际的)

231

阶段

  • 阶段2

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

    • Pennsylvania
      • Pittsburgh、Pennsylvania、美国、15260
        • University of Pittsburgh, Department of Physical Therapy, School of Health and Rehabilitation Sciences

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 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Meet the 1986 American College of Rheumatology (ACR) clinical criteria for knee osteoarthritis
  • Grade II or greater Kellgren and Lawrence radiographic changes

Exclusion Criteria:

  • History of two or more falls within the year prior to study entry
  • Unable to walk a distance of 100 feet without an assistive device or a rest period
  • Total knee arthroplasty
  • Uncontrolled hypertension
  • History of cardiovascular disease
  • History of neurological disorders that affect lower extremity function such as stroke or peripheral neuropathy
  • Corticosteroid injection to the quadriceps or patellar tendon in the past month, or 3 or more within the past year
  • Quadriceps tendon rupture, patellar tendon rupture, or patellar fracture that could place them at risk of re-injury during quadriceps strength testing
  • Pregnancy

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:1
Traditional exercise program supplemented with knee stability training activities
The addition of agility and perturbation training techniques to the traditional exercise program
有源比较器:2
Traditional exercise program
Exercises include stretching, strengthening, and aerobic exercise

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Western Ontario and McMaster OA index (WOMAC)
大体时间:Measured at baseline, 2 months, 6 months, 1 year
Measured at baseline, 2 months, 6 months, 1 year
Lower Extremity Function Scale
大体时间:Measured at baseline, 2 months, 6 months, 1 year
Measured at baseline, 2 months, 6 months, 1 year
Get Up and Go test (a physical performance measure of function)
大体时间:Measured at baseline, 2 months, 6 months
Measured at baseline, 2 months, 6 months
Knee Outcome Survey - Activities of Daily Living Scale
大体时间:Measured at baseline, 2 months, 6 months, 1 year
Measured at baseline, 2 months, 6 months, 1 year

次要结果测量

结果测量
大体时间
Cartilage morphology changes as measured by MRI
大体时间:Measured at baseline, 1 year
Measured at baseline, 1 year
Physical Activity Scale for the Elderly
大体时间:Measured at baseline, 2 months, 6 months, 1 year
Measured at baseline, 2 months, 6 months, 1 year
Quadriceps strength and activation
大体时间:Measured at baseline, 2 months, 6 months
Measured at baseline, 2 months, 6 months
Radiographic severity of OA
大体时间:Measured at baseline, 1 year
Measured at baseline, 1 year
Fear Avoidance questionnaire for the knee
大体时间:Measured at baseline, 2months, 6 months, 1 year
Measured at baseline, 2months, 6 months, 1 year
Beck Anxiety Index
大体时间:Measured at baseline, 2 months, 6 months, 1 year
Measured at baseline, 2 months, 6 months, 1 year
Center for Epidemiological Studies Depression Scale
大体时间:Measured at baseline, 2 months, 6 months, 1 year
Measured at baseline, 2 months, 6 months, 1 year
Motion analysis variables (knee motion, vertical ground reaction force, loading rates, knee adduction/abduction moment, and lower extremity muscle co-contractions during walking and a step-down task)
大体时间:Measured at baseline, 2 months, 6 months
Measured at baseline, 2 months, 6 months

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:G. Kelley Fitzgerald, PhD, PT、University of Pittsburgh, Department of Physical Therapy, School of Health and Rehabilitation Sciences

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

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

2004年4月1日

初级完成 (实际的)

2008年12月1日

研究完成 (实际的)

2008年12月1日

研究注册日期

首次提交

2004年3月3日

首先提交符合 QC 标准的

2004年3月3日

首次发布 (估计)

2004年3月4日

研究记录更新

最后更新发布 (估计)

2013年1月24日

上次提交的符合 QC 标准的更新

2013年1月23日

最后验证

2013年1月1日

更多信息

与本研究相关的术语

其他研究编号

  • NIAMS-117
  • R01AR048760-01A2 (美国 NIH 拨款/合同)

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.

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