NCT04127838

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

October 10, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 16, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

October 16, 2019

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 13, 2022

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2022

Completed
Last Updated

June 7, 2022

Status Verified

June 1, 2022

Enrollment Period

2.6 years

First QC Date

October 10, 2019

Last Update Submit

June 6, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Change in quality of life

    Changes measured in the PDQ-39 from the initial visit as compared to the visit six months later.

Study Arms (1)

Low Vision Occupational Therapy

EXPERIMENTAL

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

Interventions

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).

Also known as: Occupational Therapy
Low Vision Occupational Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • minors
  • cognitively impaired

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Occupational Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeutics

Study Officials

  • Marissa Dean, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 10, 2019

First Posted

October 16, 2019

Study Start

October 16, 2019

Primary Completion

May 13, 2022

Study Completion

June 3, 2022

Last Updated

June 7, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations