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临床试验/NCT01040962
NCT01040962已完成不适用

Fall Risk Assessment in People With Diabetic Neuropathy

Stephen D. Jernigan, PT, PhD2 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2008年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
37
试验地点
2

研究概览

简要总结

Fall risk is increased in people with diabetic peripheral neuropathy (DPN) and yet, minimal research has been conducted to identify appropriate fall risk assessment tools and improve our understanding of falls in these individuals. Purpose: The primary purpose of this study is to establish a foundation of knowledge needed to address falls in people with DPN. This will be accomplished through 1) comparing the validity of 4 fall risk assessment tools, 2) identifying risk factors for falls and 3) determining how quality of life is influenced by factors related to falls in people with DPN.

详细描述

All subjects participate in testing that involves questionnaires, cognitive testing, fall risk assessment, and other testing related to physical parameters including body mass index, glycosylated hemoglobin, lower extremity nerve conduction study, and ankle range of motion, proprioception and strength. After testing, subjects are interviewed to determine fall status (faller or non-faller). A "faller" is defined as someone that has fallen at least 2 times in the past year. Data Analysis: The validity of the fall risk assessment tools will be compared using sensitivity and specificity analyses. Variables related to ankle function, neuropathy, glycemic control and general activity will be analyzed for association with recent fall history through multivariable logistic regression. Variables related to falls, neuropathy and activity level will be analyzed for association with health-related quality of life through multivariable linear regression.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

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

入选标准

  • diagnosed with diabetic peripheral neuropathy

排除标准

  • major medical depression
  • non-diabetes related musculoskeletal problems that limit ambulation
  • open wounds on the weight bearing surfaces of the feet
  • requires another person's assistance to walk
  • uncorrected visual deficits that influence gait and/or balance
  • history of stroke or other CNS pathology that impairs gait and/or balance
  • diagnosed untreated vestibular disorder that results in gait and/or balance disturbances

研究者

发起方
Stephen D. Jernigan, PT, PhD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Stephen D. Jernigan, PT, PhD

Clinical Assistant Professor

University of Kansas Medical Center

研究点 (2)

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