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Prevalence of Visual Dysfunction in Neurological Disorders

Sponsor
University of Florida (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04836715
Collaborator
(none)
10,000
Enrollment
2
Locations
19
Anticipated Duration (Months)
5000
Patients Per Site
263.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective is to determine the prevalence of visual dysfunction in People with Parkinson's Disease (PwP). The investigators will administer the: Visual Impairment in Parkinson's Disease Screen and Revised-Self-Report Assessment of Functional Visual Performance. Patients seen at Fixel Institute and their caregivers will be invited to participate. Responses to the 2 questionnaires will help determine prevalence rates of visual dysfunction in PwP compared to those both with and without other neurological conditions.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The purpose of this study is to identify the prevalence of visual dysfunction among Persons with Parkinson's Disease, compared to other neurological conditions and controls without neurological conditions.

    Data will be collected anonymously via RedCap. Patients seen at the Fixel Institute that have consented to be contacted regarding research opportunities will be recruited via blast email and advertisement in our Institute's monthly newsletter, the Movement Messenger. The email and newsletter will contain a link for participation in surveys within RedCap so the surveys can be completed anonymously at home. Participation will be completely voluntary and responses will be recorded anonymously. Data will include responses to the following: screening questions, the VIPDQ (Visual Impairment in PD Questionnaire), and the R-SRAFVP (Revised-Self-Report Assessment of Functional Visual Performance).

    The investigators will calculate the prevalence of visual impairment (from the VIPDQ) and dysfunction in performance of daily activities (from the R-SRAFVP) for PwP and compare this to the prevalence occurring in other neurological populations as well as the population without any neurological conditions. Other data are collected so the investigators can then evaluate potential confounds or covariates. To ensure statistical methods are accurate, a statistician will be consulted.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    10000 participants
    Observational Model:
    Other
    Time Perspective:
    Other
    Official Title:
    Prevalence of Visual Dysfunction in Persons With Parkinson's Disease and Other Neurological Disorders
    Anticipated Study Start Date :
    Aug 1, 2021
    Anticipated Primary Completion Date :
    Mar 1, 2022
    Anticipated Study Completion Date :
    Mar 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Parkinson's Disease

    Individuals with idiopathic Parkinson's Disease and no other neurological disease
    Other Neurological Disorders

    Individuals with one neurological disorder other than Parkinson's Disease (e.g. Multiple Sclerosis, Amyotrophic Lateral Sclerosis, Traumatic Brain Injury, Parkinsonism)
    Healthy

    Individuals without any neurological disorder

    Outcome Measures

    Primary Outcome Measures

    1. Visual Dysfunction [1 day]

      Determined from VIPDQ: (with the highest and lowest scores on the VIPD-Q Score). Answers are given on a 4-point Likert scale ranging from "never have problems" to "daily problems"

    2. Functional Visual Performance [1 day]

      Determined from R-SRA FVP: SRAFVP %

    Other Outcome Measures

    1. Correlations between Visual Dysfunction and Functional Visual Performance [1 day]

      Correlation Coefficient: VIPDQ score and SRAFVP % will be analyzed statistically to report correlation coefficient

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    • Persons with Parkinson's Disease: Confirmed diagnosis of Parkinson's Disease without presence of any other neurological condition.

    • Persons without Parkinson's Disease (Controls): No previous diagnosis of any neurological condition

    • Persons with a single other neurological disorder (Neuro Controls): Confirmed diagnosis of other neurological condition (e.g. ALS, multiple sclerosis, essential tremor, ataxia, etc).

    Exclusion Criteria:

    • Children (ages younger than 18 years of age)

    • Persons with more than one diagnosed neurological condition.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UF Health Rehab - Fixel Institute Gainesville Florida United States 32608
    2 University of Florida Gainesville Florida United States 32608

    Sponsors and Collaborators

    • University of Florida

    Investigators

    • Principal Investigator: Nicole J Tester, PhD, MOT, OTR/L, MSCS, University of Florida/UF Health Rehab

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Florida
    ClinicalTrials.gov Identifier:
    NCT04836715
    Other Study ID Numbers:
    • IRB202100649
    First Posted:
    Apr 8, 2021
    Last Update Posted:
    Jul 9, 2021
    Last Verified:
    Jul 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Parkinson Disease
    Nervous System Diseases
    Vision Disorders

    Study Results

    No Results Posted as of Jul 9, 2021