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

Completed

• Conditions: Parkinson Disease

• Registration Number: NCT03845634
• Lead Sponsor: Assistive Technology Clinic, Canada

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-13
• Study First Submitted: 2019-02-07
• Study First Submitted QC: 2019-02-15
• Study First Posted: 2019-02-19
• Primary Completion: 2019-09-11
• Study Completion: 2019-09-11
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-07
• Last Update Posted: 2020-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 202

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Item-to-total correlation	Baseline	correlation -1.0 - 1.0
Inter-rater reliability	1 week after Baseline	kappa 0 - 1.0
Concurrent validity	Baseline	correlation -1.0 - 1.0
Cronbach's Alpha	Baseline	alpha 0 - 1.0

Trial Locations

Locations (1)

Assistive Technology Clinic; 🇨🇦 Toronto, Ontario, Canada