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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03845634
• Other study ID #: 10-27
• Status: Completed
• Start date: September 13, 2018
• Est. completion date: September 11, 2019

Study information

• Verified date: July 2020
• Source: Assistive Technology Clinic, Canada
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: September 11, 2019
• Est. primary completion date: September 11, 2019
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Locations

Country	Name	City	State
Canada	Assistive Technology Clinic	Toronto	Ontario

Sponsors (7)

Lead Sponsor	Collaborator
Assistive Technology Clinic, Canada	Rush University, The Cleveland Clinic, The Parkinson Study Group, University Health Network, Toronto, University of Cincinnati, University of Michigan

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cronbach's Alpha	alpha 0 - 1.0	Baseline
Primary	Item-to-total correlation	correlation -1.0 - 1.0	Baseline
Primary	Inter-rater reliability	kappa 0 - 1.0	1 week after Baseline
Primary	Concurrent validity	correlation -1.0 - 1.0	Baseline