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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03845634

Enrollment

202

Registered

2019-02-19

Start date

2018-09-13

Completion date

2019-09-11

Last updated

2020-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

Keywords

Non-motor fluctuation

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame	Description
Cronbach's Alpha	Baseline	alpha 0 - 1.0
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

Countries

Canada

Outcome results