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

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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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Sex eligibility

All sexes

Study type

Observational

Primary location

Assistive Technology Clinic

Toronto, Ontario, M6A 2E1, Canada

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

Cronbach's Alpha

Time frame: Baseline

alpha 0 - 1.0
Item-to-total correlation

Time frame: Baseline

correlation -1.0 - 1.0
Inter-rater reliability

Time frame: 1 week after Baseline

kappa 0 - 1.0
Concurrent validity

Time frame: Baseline

correlation -1.0 - 1.0

Sponsors and collaborators

Lead sponsor

Assistive Technology Clinic, Canada

Other

Collaborators

Rush University
The Cleveland Clinic
The Parkinson Study Group
University Health Network, Toronto
University of Cincinnati
University of Michigan

Registry information

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2019
First posted: Feb 19, 2019
Registry last updated: Jul 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed