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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

Tracking Information
First Submitted Date February 7, 2019
First Posted Date February 19, 2019
Last Update Posted Date February 19, 2019
Actual Study Start Date September 13, 2018
Estimated Primary Completion Date April 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 15, 2019)
  • Cronbach's Alpha [ Time Frame: Baseline ]
    alpha 0 - 1.0
  • Item-to-total correlation [ Time Frame: Baseline ]
    correlation -1.0 - 1.0
  • Inter-rater reliability [ Time Frame: 1 week after Baseline ]
    kappa 0 - 1.0
  • Concurrent validity [ Time Frame: Baseline ]
    correlation -1.0 - 1.0
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Validation of a Non-Motor Fluctuation Assessment Instrument (NoMoFA) for Parkinson's Disease
Official Title Validation of a Non-Motor Fluctuation Assessment Instrument (NoMoFA) for Parkinson's Disease
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 Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Parkinson Disease
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 15, 2019)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 2019
Estimated Primary Completion Date April 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Albie Law 416-784-3600 ext 7000 albie.law@assistivetechnologyclinic.ca
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT03845634
Other Study ID Numbers 10-27
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Assistive Technology Clinic, Canada
Study Sponsor Assistive Technology Clinic, Canada
Collaborators
  • University of Cincinnati
  • The Cleveland Clinic
  • University Health Network, Toronto
  • University of Michigan
  • Rush University
  • The Parkinson Study Group
Investigators
Principal Investigator: Galit Kleiner, MD Assistive Technology Clinic
PRS Account Assistive Technology Clinic, Canada
Verification Date February 2019