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临床试验/NCT03209960
NCT03209960已完成不适用

Validity and Inter-Rater Reliability of a Novel Bedside Referral Tool for Spasticity

Vanderbilt University Medical Center1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年1月30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
60
试验地点
1
主要终点
Sensitivity of Bedside Referral Tool

研究概览

简要总结

The purpose of this study is to improve spasticity diagnosis through development of a simple physical examination guide for primary care providers to identify patients who would benefit from being referred to a movement disorders neurologist for a spasticity evaluation.

详细描述

The aim of this study is to improve spasticity (a form of muscle rigidity) diagnosis through development of a simple physical examination guide for primary care providers/clinicians. This guide will assist in the identification of patients who would benefit from being referred to a movement disorders neurologist for spasticity evaluation and subsequent treatment. The examination tool will be tested for bedside implementation in all consenting participants residing in Tennessee State Veteran's Home, which is a long-term care facility in Murfreesboro, TN. Each of the 140 residents will receive one neurological examination and two physical examinations guided by the referral tool. A medical record review will also be performed.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Males or female subjects of any race, aged 18 and above
  • Resident of the selected long-term care facility
  • The subject, or if appropriate their medical decision maker, is willing and able to provide written informed consent.

排除标准

  • Subjects for whom participation in the study may cause medical harm

结局指标

主要结局

Sensitivity of Bedside Referral Tool

时间窗: Up to three months after consent is obtained

Two Vanderbilt primary care providers (a nurse practitioner and a primary care physician) will examine all consented residents, guided by the bedside referral tool, to determine if a referral to a movement disorders neurologist is requires for a spasticity consultation. The findings of each exam will be recorded by the research coordinator, who will keep the results blinded from the other raters. Each rater's referral decision will be compared to the diagnosis made by the movement disorders neurologist.

次要结局

  • Spasticity Diagnosis(Up to three months after consent is obtained)
  • Inter-rater Reliability(Up to three months after consent is obtained)
  • Specificity of Bedside Referral Tool(Up to three months after consent is obtained)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

David Charles

Professor and Vice-Chairman of Neurology; Chief Medical Officer, Vanderbilt Neuroscience Institute

Vanderbilt University Medical Center

研究点 (1)

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