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

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ClinicalTrials.gov Identifier: NCT03845634
Recruitment Status : Recruiting
First Posted : February 19, 2019
Last Update Posted : February 19, 2019
Sponsor:
Collaborators:
University of Cincinnati
The Cleveland Clinic
University Health Network, Toronto
University of Michigan
Rush University
The Parkinson Study Group
Information provided by (Responsible Party):
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.

Condition or disease
Parkinson Disease

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of a Non-Motor Fluctuation Assessment Instrument (NoMoFA) for Parkinson's Disease
Actual Study Start Date : September 13, 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Cronbach's Alpha [ Time Frame: Baseline ]
    alpha 0 - 1.0

  2. Item-to-total correlation [ Time Frame: Baseline ]
    correlation -1.0 - 1.0

  3. Inter-rater reliability [ Time Frame: 1 week after Baseline ]
    kappa 0 - 1.0

  4. Concurrent validity [ Time Frame: Baseline ]
    correlation -1.0 - 1.0



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03845634


Contacts
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Contact: Albie Law 416-784-3600 ext 7000 albie.law@assistivetechnologyclinic.ca

Locations
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Canada, Ontario
Assistive Technology Clinic Recruiting
Toronto, Ontario, Canada, M6A 2E1
Contact: Albie Law    416-784-3600 ext 7000    albie.law@assistivetechnologyclinic.ca   
Principal Investigator: Galit Kleiner, MD         
Sponsors and Collaborators
Assistive Technology Clinic, Canada
University of Cincinnati
The Cleveland Clinic
University Health Network, Toronto
University of Michigan
Rush University
The Parkinson Study Group
Investigators
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Principal Investigator: Galit Kleiner, MD Assistive Technology Clinic

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Responsible Party: Assistive Technology Clinic, Canada
ClinicalTrials.gov Identifier: NCT03845634     History of Changes
Other Study ID Numbers: 10-27
First Posted: February 19, 2019    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assistive Technology Clinic, Canada:
Non-motor fluctuation

Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases