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临床试验/NCT06882928
NCT06882928尚未招募不适用

Applications of Ultrasound and Physical Parameters in Assessing Fall Risk Among Patients With Knee Osteoarthritis: A Prospective Cohort Study

National Taiwan University Clinical Trial Center1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2025年3月24日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
250
试验地点
1
主要终点
Fall Incident Tracking

研究概览

简要总结

Falls are a significant issue for patients with knee osteoarthritis, as they can lead to hospitalization or even more severe consequences. Therefore, it is crucial to assess fall risk early in rehabilitation clinics. Sarcopenia, which is the reduction of muscle mass, increases the risk of falls. This study involved 250 adults with knee osteoarthritis, using a technology called POCUS to assess muscle mass, combined with other tests to track fall incidents over three months. The study is expected to find correlations between falls and factors like muscle mass and grip strength. This information can help doctors better predict which patients are at risk of falling and take preventive measures early. Future research will explore the effectiveness of different prevention strategies.

详细描述

Background

Falls represent a significant health issue for patients with knee osteoarthritis, potentially leading to hospitalization, disability, or even death. Early screening for fall risk in rehabilitation clinics is crucial; however, challenges arise due to time constraints and individual differences among patients. Sarcopenia, characterized by a reduction in muscle mass, is closely associated with an increased risk of falls, and point-of-care ultrasound (POCUS) offers a non-invasive and effective tool for assessing muscle mass.

Methods

This prospective study involved 250 adults with knee osteoarthritis attending the orthopedic physical therapy outpatient department at National Taiwan University Hospital. POCUS technology was utilized to evaluate muscle mass, complemented by grip strength tests, lower limb strength assessments, self-reported fall risk questionnaires, sarcopenia assessments, get-up-and-go tests, thirty-second sit-to-stand tests, general nutrition screening for malnutrition, and bioimpedance analysis. A three-month follow-up study was conducted to monitor fall incidents.

Expected Results

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Males and females aged 60 and above, who are willing to sign an informed consent form.
  • •Participants must have a clinically confirmed diagnosis of knee osteoarthritis.
  • •Participants must have received at least one treatment in the outpatient rehabilitation department during the study period.
  • •Participants must be able to walk independently, even with the aid of assistive devices.

排除标准

  • •Individuals who have undergone lower limb surgery or have significant lower limb deformities.
  • •Individuals with severe cognitive impairment who are unable to understand or comply with the study procedures.
  • •Individuals who cannot communicate in a language understandable by the research team.
  • •Individuals with severe comorbidities that affect assessment or treatment (e.g., unable to safely complete assessments or treatments).
  • •Individuals planning to undergo knee surgery during the study period.

结局指标

主要结局

Fall Incident Tracking

时间窗: Three-month period

Participants will be monitored for fall incidents over a three-month period, and the accuracy of the model predictions will be analyzed.

次要结局

  • POCUS Assessment(Baseline POCUS Assessment)
  • Bioelectrical Impedance Analysis (BIA) Measurement(Baseline BIA measurement)
  • Timed Up and Go (TUG) Test(Baseline Timed Up and Go (TUG) Test)
  • Height Measurement(Baseline height measurement)
  • Grip strength testing(Baseline grip strength)
  • Sarcopenia Risk Assessment Questionnaire (SARC-F)(Baseline Sarcopenia Risk Assessment Questionnaire (SARC-F))
  • Knee extension strength testing(Baseline knee extension strength testing)
  • 30-Second Sit-to-Stand Test(Baseline 30-Second Sit-to-Stand Test)
  • Falls Efficacy Scale-International (FES-I)(Baseline Falls Efficacy Scale-International (FES-I))
  • Body weight measurement(Baseline body weight measurement)

研究者

发起方
National Taiwan University Clinical Trial Center
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

National Taiwan University Clinical Trial Center

physical therapist

National Taiwan University Hospital

研究点 (1)

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