search
Back to results

Low Vision Occupational Therapy in Parkinson's Disease

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low Vision Occupational Therapy
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Parkinson Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Low Vision Occupational Therapy

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
October 10, 2019
Last Updated
June 6, 2022
Sponsor
University of Alabama at Birmingham
search

1. Study Identification

Unique Protocol Identification Number
NCT04127838
Brief Title
Low Vision Occupational Therapy in Parkinson's Disease
Official Title
Low Vision Occupational Therapy in Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
October 16, 2019 (Actual)
Primary Completion Date
May 13, 2022 (Actual)
Study Completion Date
June 3, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low Vision Occupational Therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Low Vision Occupational Therapy
Other Intervention Name(s)
Occupational Therapy
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in Activities of Daily Living
Description
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.
Time Frame
Changes measured in the R-SRAFVP from the initial visit as compared to the visit six months later.
Secondary Outcome Measure Information:
Title
Change in quality of life
Description
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
Time Frame
Changes measured in the PDQ-39 from the initial visit as compared to the visit six months later.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marissa Dean, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Low Vision Occupational Therapy in Parkinson's Disease

We'll reach out to this number within 24 hrs