Validation of a Non-Motor Fluctuation Assessment Instrument (NoMoFA) for Parkinson's Disease
1 other identifier
observational
202
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2018
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 13, 2018
CompletedFirst Submitted
Initial submission to the registry
February 7, 2019
CompletedFirst Posted
Study publicly available on registry
February 19, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 11, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 11, 2019
CompletedJuly 8, 2020
July 1, 2020
12 months
February 7, 2019
July 7, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Cronbach's Alpha
alpha 0 - 1.0
Baseline
Item-to-total correlation
correlation -1.0 - 1.0
Baseline
Inter-rater reliability
kappa 0 - 1.0
1 week after Baseline
Concurrent validity
correlation -1.0 - 1.0
Baseline
Eligibility Criteria
Individuals, both men and women, who have been diagnosed with idiopathic Parkinson's Disease and have motor and non-motor fluctuating symptoms are invited to participate in the study. To ensure a representative sample, subjects spanning the disease spectrum will be equally represented in terms of mild, moderate and advanced symptoms of PD.
You may qualify if:
- 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
You may not qualify if:
- Atypical Parkinsonism
- Lack of motor fluctuations
- Lack of English language proficiency in either subject or caregiver
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Assistive Technology Clinic, Canadalead
- University of Cincinnaticollaborator
- The Cleveland Cliniccollaborator
- University Health Network, Torontocollaborator
- University of Michigancollaborator
- Rush Universitycollaborator
- The Parkinson Study Groupcollaborator
Study Sites (1)
Assistive Technology Clinic
Toronto, Ontario, M6A 2E1, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Galit Kleiner, MD
Assistive Technology Clinic
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 7, 2019
First Posted
February 19, 2019
Study Start
September 13, 2018
Primary Completion
September 11, 2019
Study Completion
September 11, 2019
Last Updated
July 8, 2020
Record last verified: 2020-07