Low Vision Occupational Therapy in Parkinson's Disease

The primary aim of this study is to determine whether low-vision occupational therapy improves quality of life in Parkinson's Disease (PD) patients. Low-vision occupational therapy has not been previously studied in PD patients, and we suspect that this is a beneficial treatment option for PD patients as vision impairment is common in the PD patient population. Our primary objective will assess whether quality of life was improved following a low-vision occupational therapy session.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Behavioral: Low Vision Occupational Therapy

Detailed Description

This project will be an exploratory study that will evaluate the benefits of low vision occupational therapy in the treatment of PD using the Revised Self-Report Assessment of Functional Visual Performance (R-SRAFVP) as the primary outcome measure. This tool assesses 33 vision-dependent ADLs ranging from personal care, leisurely activities, clothing management, meal preparation, etc. Patients are able to rank their ability to complete these tasks as independent, minimally difficult, moderately difficult, greatly difficult, unable, or not applicable. This will allow us to capture potential changes in the patient's ability to complete vision-specific ADLs following low vision occupational therapy. In addition, we will also evaluate quality of life using the Parkinson's Disease Questionnaire (PDQ-39), to compare this broad outcome measure with the R-SRAFVP.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18 and older
• seen at UAB Movement Disorders Clinic
• diagnosis of idiopathic Parkinson's Disease
• able to read, speak, and understand spoken English.

Exclusion Criteria:

• minors
• cognitively impaired

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low Vision Occupational Therapy; The anticipated low vision occupational therapy intervention strategy includes training participants to compensate for their vision more effectively for increased participation in ADLs and IADLs.	Behavioral: Low Vision Occupational Therapy; Occupational therapy may include methods to effectively modify environments (such as addition of task lighting), training in the use of assistive technology (such as voice activated devices), teaching new skills (such as sensory substitution) and prevention of accidents and injury (such as home safety modifications).; Other Names: Occupational Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Activities of Daily Living	Revised Self-Report Assessment of Functional Visual Performance (R-SRAFVP). This tool assesses 33 vision-dependent ADLs ranging from personal care, leisurely activities, clothing management, meal preparation, etc. Patients are able to rank their ability to complete these tasks as independent, minimally difficult, moderately difficult, greatly difficult, unable, or not applicable.	Changes measured in the R-SRAFVP from the initial visit as compared to the visit six months later.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in quality of life	Parkinson's Disease Questionnaire (PDQ-39); The PDQ-39 assesses how often people affected by Parkinson's experience difficulties across 8 dimensions of daily living including relationships, social situations and communication	Changes measured in the PDQ-39 from the initial visit as compared to the visit six months later.

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Marissa Dean, MD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2019
• Primary Completion (Actual): May 13, 2022
• Study Completion (Actual): June 3, 2022

Study Registration Dates

• First Submitted: October 10, 2019
• First Submitted That Met QC Criteria: October 13, 2019
• First Posted (Actual): October 16, 2019

Study Record Updates

• Last Update Posted (Actual): June 7, 2022
• Last Update Submitted That Met QC Criteria: June 6, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Sensation Disorders; Vision Disorders; Parkinson Disease; Vision, Low
• Other Study ID Numbers: IRB-300003853

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No