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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

202 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-13

Study Completion Date

2019-09-11

Brief Summary

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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.

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Detailed Description

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Conditions

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Parkinson Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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