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临床试验/NCT01333189
NCT01333189已完成不适用

Improving Function After Knee Arthroplasty With Weight-Bearing Biofeedback

University of Colorado, Denver2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2011年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
26
试验地点
2
主要终点
Weight-bearing Ratio During Five Times Sit-to-Stand Test (FTSST)

研究概览

简要总结

The purpose of this study is to determine if rehabilitation using weight-bearing biofeedback training following total knee arthroplasty (TKA) is more effective than standard rehabilitation methods in promoting weight-bearing symmetry through the lower limbs during functional activities such as sit-to-stand transfers and walking. Secondary outcomes of interest include functional measures and internal moment at the hip, knee, and ankle joints during sit-to-stand and walking.

详细描述

People who have had knee replacement surgery typically have worse physical function compared to healthy people of similar age. This problem occurs despite completion of standard rehabilitation programs. One reason for less-than-optimal restoration of physical function is that standard rehabilitation does not effectively address habitual movement patterns that persist after surgery. These movement patterns are characterized by patients placing less weight on their surgical leg compared to their non-surgical leg after surgery. This asymmetrical movement pattern has been identified by researchers and shown to not completely resolve after knee replacement surgery, even though the surgery reliably reduces knee pain. The persistence of asymmetrical weight-bearing during every day activity may limit the stimulus needed for full recovery by the muscles and joints of the surgical leg. By promoting increased loading of the surgical leg, a greater stimulus can be provided to promote better functional recovery, compared with standard rehabilitation. As a result, people may subsequently move more symmetrically with improved recovery of physical function. Improved function would in turn promote the person's ability to participate in life events, limiting disability. Considering that over 500,000 knee replacement surgeries occur in the United States each year, maximizing functional recovery and limiting disability following surgery are important goals.

The investigators propose a new method of exercising following knee replacement surgery. This method involves using a commercially available game system to promote "re-loading" of the surgical limb. The game system has games designed to allow the person playing to move objects or characters on a screen by shifting his/her weight from one leg to another while standing on an instrumented "balance board". The investigators have developed an exercise program to promote shifting weight to the surgical limb, by choosing appropriate games and manipulating the goals of those games. It is the investigators' hypothesis that early application of this surgical leg "re-loading" intervention after knee replacement will result in meaningful improvement in physical function by improving movement symmetry.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Single (Participant)

入排标准

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

入选标准

  • unilateral total knee arthroplasty, body mass index <40 kg/m^2

排除标准

  • neurological, vascular or cardiac problems that limited physical function, contralateral knee pain greater than 2/10 on a numerical pain rating scale, severe osteoarthritis or other orthopaedic conditions in the non-operated lower extremity that limited function, sub-acute inpatient rehabilitation following unilateral total knee arthroplasty, uncontrolled diabetes, smoking or drug abuse, living >45 minutes away from the outpatient rehabilitation clinic, surgical complication requiring an altered course of rehabilitation, inability to walk 30 meters without an assistive device or inability to rise from a chair without use of arms

结局指标

主要结局

Weight-bearing Ratio During Five Times Sit-to-Stand Test (FTSST)

时间窗: 6 weeks post-operative

Weight-bearing ratio is measured during transitions between sitting and standing and is indicated by symmetry in vertical ground reaction force (vGRF) between lower limbs. Ratios reported are (vGRF of the Surgical Limb):(vGRF Non-Surgical Limb).

次要结局

  • Weight-bearing Ratio During Walking(26 weeks post-operative)
  • Walking Speed(26 weeks post-operative)
  • Hip, Knee, and Ankle Joint Moments During Walking(6 weeks post-operative)
  • Weight-bearing Ratio During Five Times Sit-to-Stand Test (FTSST)(26 weeks post-operative)
  • Hip, Knee, and Ankle Moments During Walking(26 weeks post-operative)
  • Five Times Sit-to-Stand Test (FTSST)(26 weeks post-operative)
  • Hip, Knee, and Ankle Joint Moments During Five Times Sit-to-Stand Test(26 weeks post-operative)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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