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

Assistive Technology Clinic, Canada

Status: Completed

Conditions: Parkinson Disease

Study type: Observational

Funder types: Other; NETWORK

Identifiers

NCT03845634

10-27

Details and patient eligibility

About

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.

Enrollment: 202 patients

Sex: All

Volunteers: No Healthy Volunteers

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