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临床试验/NCT03845634
NCT03845634已完成不适用

Validation of a Non-Motor Fluctuation Assessment Instrument (NoMoFA) for Parkinson's Disease

Assistive Technology Clinic, Canada1 个研究点 分布在 1 个国家目标入组 202 人开始时间: 2018年9月13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
202
试验地点
1
主要终点
Item-to-total correlation

研究概览

简要总结

Investigators have developed a comprehensive questionnaire that assesses the presence of non-motor fluctuations (NMFs) in individuals with Parkinson's disease (PD). To date, 189 participants with PD have been assessed for preliminary data analysis prior to developing the penultimate version. At this time the objectives are to: (i) assess the scale's internal consistency and item-to-total correlations; (ii) assess test-retest reliability; (iii) use factor analysis and reliability measures to guide item reduction; (iv) assess construct validity; and (v) assess the scales ability to discriminate between static non-motor symptoms and non-motor symptoms which fluctuate (vi) estimate the relative distribution of cognitive, psychiatric, autonomic, sleep and sensory NMFs in PD patients with motor fluctuations and their impact on quality of life in Parkinson's disease.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Diagnosed with Idiopathic Parkinson's Disease (according to the United Kingdom Parkinson's Disease Society Brain Bank clinical diagnostic criteria)
  • Stage of symptoms is mild, moderate or severe as per the Hoehn & Yahr scale
  • Have motor fluctuations
  • Have non-motor fluctuations

排除标准

  • Atypical Parkinsonism
  • Lack of motor fluctuations
  • Lack of English language proficiency in either subject or caregiver

结局指标

主要结局

Item-to-total correlation

时间窗: Baseline

correlation -1.0 - 1.0

Inter-rater reliability

时间窗: 1 week after Baseline

kappa 0 - 1.0

Concurrent validity

时间窗: Baseline

correlation -1.0 - 1.0

Cronbach's Alpha

时间窗: Baseline

alpha 0 - 1.0

次要结局

未报告次要终点

研究者

发起方
Assistive Technology Clinic, Canada
申办方类型
Other
责任方
Sponsor

研究点 (1)

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