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临床试验/NCT05420194
NCT05420194已完成不适用

Assessment of Postural Stability in Patients With Total Knee Arthroplasty

Acibadem University2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年9月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
2
主要终点
Postural Stability

研究概览

简要总结

Postural balance can be described as the integration of the information obtained from visual, vestibular and somatosensory systems. Postural stability is achieved by sensory information about the static or dynamic position of the body resulting in an appropriate motor response. Poor postural stability in individuals with knee osteoarthritis often results in an increased risk of falling and decrease in mobility. It has been reported that 40% of knee osteoarthritis patients fall at least once in a year. Total knee arthroplasty (TKA) is a surgical treatment approach applied to individuals with advanced knee osteoarthritis. It has been shown that this method provides an improvement in the postural stability levels of individuals compared to the preoperative period and a decrease in number of falls reported by the patient. Even if this improvement is achieved, postural stability losses can still be observed in individuals undergoing TKA which affect balance performance.

Obesity is defined by an excessive increase in the ratio of body fat mass relative to lean mass. Individuals with a Body Mass Index (BMI) above 30 kg/m2 are defined as obese. Changes in body composition and increased adiposity rate lead to significant locomotor system problems. A decrease in postural control, increased risk of falling or fear of falling can be defined as locomotor system problems. It has been reported that there is a relationship between increased fat ratio and loss of postural stability in adult obese individuals.

In a published study, it was reported that as of 2029, 46% of the population in America will be obese or morbidly obese, and 69% of individuals who have undergone total knee arthroplasty surgery will be obese or morbidly obese. Obesity causes several complications such as increased mortality and increase in likelihood of revision surgery that can be seen after total knee arthroplasty. Therefore, it is clinically important to determine the functional status and balance status in order to reduce the possible long-term complications that may develop in the post-operative period and the risk of falling, especially in obese individuals.

The effects of increasing obesity level on postural stability in individuals undergoing total knee arthroplasty are unknown. In this context, the aim of our study is to compare the postural stability levels of normal, overweight and obese individuals who underwent total knee arthroplasty.

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
45 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Follow-up period is between 1-5 years,
  • Volunteer to participate in the study,

排除标准

  • Having undergone revision surgery on the same or opposite knee after total knee arthroplasty,
  • Presence of vertigo or another neurological disease,
  • Patients who have undergone total hip replacement.

结局指标

主要结局

Postural Stability

时间窗: Day 1

Postural stability of the participants will be evaluated with the NeuroCom Balance Master Static Posturography device. Posturography devices allow us to quantitatively evaluate posture and balance and obtain objective results by measuring postural sway. Sensory impairment, motor impairment and functional limitations can be evaluated with this device. In the study, the Clinical Test of Sensory Interaction on Balance (mCTSIB) will be used to evaluate the sensory status, and the Limits of Stability-LOS Test, Rhythmic Weight Shift-RWS will be used to evaluate the motor status. The Unilateral Stance-US Test will also be used to evaluate the functional limitation.

Falls Efficacy Scale

时间窗: Day 1

Falls Efficacy Scale measures fear of falling during different social or physical activities at home and outside with a scale consisting of 16 questions. The total score ranges from 16 to 64, and a high score indicates greater fear of falling.

次要结局

  • Short Physical Performance Battery (SPPB)(Day 1)
  • Timed Up and Go Test(Day 1)
  • Pain Severity(Day 1)

研究者

发起方
Acibadem University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Özgül Öztürk

Assistant Professor

Acibadem University

研究点 (2)

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