Parkinson DiseaseNCT04836715
Prevalence of Visual Dysfunction in Neurological Disorders
An observational study of Parkinson Disease and Other Neurological Disorders, run by University of Florida at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease, Other Neurological Disorders, Healthy
- How many people
- 92 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Jan 2021to 1 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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).
Who may be able to join
- 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).
Who cannot join
- Children (ages younger than 18 years of age)
- Persons with more than one diagnosed neurological condition.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UF Health Rehab - Fixel Institute
Gainesville, Florida, 32608
University of Florida
Gainesville, Florida, 32608
About this study
Official title: Prevalence of Visual Dysfunction in Persons With Parkinson's Disease and Other Neurological Disorders
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.
Read the 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.
- Conditions
- Parkinson Disease, Other Neurological Disorders, Healthy
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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"
Measured: 1 day
Functional Visual Performance
Determined from R-SRA FVP: SRAFVP %
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start10 Jan 2021
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicole J Tester, PhD, MOT, OTR/L, MSCS, Principal investigator, University of Florida/UF Health Rehab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04836715
- Sponsor's protocol ID
- IRB202100649
- Status last verified
- Jun 2024
- First submitted
- 5 Apr 2021
- Last updated
- 12 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Visual Dysfunction in Persons With Parkinson's Disease and Other Neurological Disorders
- ClinicalTrials.gov ID
- NCT04836715
- Acronym / sponsor ID
- IRB202100649
- Conditions
- Parkinson Disease, Other Neurological Disorders, Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 10 Jan 2021 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (2 listed)
- Children (ages younger than 18 years of age)
- Persons with more than one diagnosed neurological condition.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Visual Dysfunction
Time frame: 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"
Functional Visual Performance
Time frame: 1 day
Determined from R-SRA FVP: SRAFVP %
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicole J Tester, PhD, MOT, OTR/L, MSCS principal investigator
University of Florida/UF Health Rehab
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and Other Neurological Disorders, run by University of Florida at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Dysfunction (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2024.