NCT04836715

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 5, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 8, 2021

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

June 12, 2024

Status Verified

June 1, 2024

Enrollment Period

2.9 years

First QC Date

April 5, 2021

Last Update Submit

June 10, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Visual Dysfunction

    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"

    1 day

  • Functional Visual Performance

    Determined from R-SRA FVP: SRAFVP %

    1 day

Other Outcomes (1)

  • Correlations between Visual Dysfunction and Functional Visual Performance

    1 day

Study Arms (3)

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

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

1. Persons with Parkinson's Disease 2. Persons without a Neurological Condition (Controls) 3. Persons with Other Neurological Conditions (e.g. ALS, TBI, MS, CBT/CBS, MSA, PSP, MCI, etc).

You may qualify if:

  • 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).

You may not qualify if:

  • Children (ages younger than 18 years of age)
  • Persons with more than one diagnosed neurological condition.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UF Health Rehab - Fixel Institute

Gainesville, Florida, 32608, United States

Location

University of Florida

Gainesville, Florida, 32608, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Nicole J Tester, PhD, MOT, OTR/L, MSCS

    University of Florida/UF Health Rehab

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2021

First Posted

April 8, 2021

Study Start

January 10, 2021

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

June 12, 2024

Record last verified: 2024-06

Locations