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临床试验/NCT04877873
NCT04877873已完成不适用

Dual-task Gait Performance in People With Knee Osteoarthritis Before and After Knee Replacement Surgery

University of Haifa1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2020年10月19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
38
试验地点
1
主要终点
Change in Gait speed

研究概览

简要总结

Knee Osteoarthritis (OA) is one of the most common conditions causing disability and limitation in the elderly population, with 13% of women and 10% of men over the age of 60 suffering from symptomatic knee osteoarthritis. Pain and other symptoms of OA significantly affect the quality of life, manifesting itself in pain, decreased range of motion, functional limitation and change in gait patterns.

Total Knee Replacement Surgery (TKR) is the most common solution for patients with advanced cartilage erosion and is considered a successful surgery with high satisfaction rates (about 80%). The surgery becomes necessary when pain limits the daily functioning and impairs the quality of life and after the failure of conservative treatment.

Still, patients undergoing TKR suffer in the first period after surgery from pain, decreased balance and proprioceptive impairment. Despite the improvement in pain and function, the rates of falls after surgery do not change drastically and remain high.

About a third of older adults fall each year, leading to fractures, functional decline and in some cases death. Walking is a complex task, and with advancing age walking becomes less automatic and requires additional attention. Among adults, it is known that an increased risk of falls is associated with reduced ability to perform complex walking tasks, such as walking while talking or crossing obstacles.

After TKR, most falls occur while walking due to slipping / tripping. In addition, proprioceptive impairment, pain and poor balance are associated with an increased risk of falling after TKR. The mechanism underlying these effects may be increased allocation of cognitive resources to walking. Thus, this study will examine the ability of people before and after TKR to perform complex walking tasks, in order to examine the change in attention allocation to walking following surgery. It is hypothesized that after surgery, the ability to walk while performing an additional task will be lower than prior to surgery.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
65 Years 至 90 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Able to walk at least for 1 minute with no assistive device
  • Able to understand and complete simple instructions

排除标准

  • Diagnosed dementia
  • Diseases impairing balance
  • Diagnosed rheumatoid arthritis

结局指标

主要结局

Change in Gait speed

时间窗: One month prior to surgery, 4.5 months post-surgery

Change in gait speed as measured using an instrumented mat

Change in gait variability

时间窗: One month prior to surgery, 4.5 months post-surgery

Change in coefficient of variation of stride time and stride length, as measured using an instrumented mat

次要结局

  • Change in Pain, stiffness, physical function(One month prior to surgery, 4.5 months post-surgery)
  • Change in Joint position sense(One month prior to surgery, 4.5 months post-surgery)
  • Change in balance self-efficacy(One month prior to surgery, 4.5 months post-surgery)
  • Cognitive function(One month prior to surgery)
  • Change in dynamic Balance(One month prior to surgery, 4.5 months post-surgery)
  • Change in movement reinvestment(One month prior to surgery, 4.5 months post-surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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