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