Low-Fidelity Driving Simulator Training in Parkinson's Disease.

University of Kansas

Status

Not yet enrolling

Conditions

Parkinson's Disease (PD)

Treatments

Other: Low-fidelity driving simulator training

Study type

Interventional

Funder types

Other

Identifiers

NCT07463755

STUDY00161777

Details and patient eligibility

About

The goal of this clinical trial is to learn if low-fidelity driving simulator training works to improve cognitive performance, driving behavior, and driving aptitude in individuals with Parkinson's disease. The main questions it aims to answer are:

Does low-fidelity driving simulator training improve cognitive performance?
Does low-fidelity driving simulator training improve driving performance?
Does low-fidelity driving simulator training improve driving aptitude?

Researchers will compare driving simulator training to no-training (waitlist control group) to see if the low-fidelity driving simulator is effective in individuals with Parkinson's disease.

Participants will:

Undergo 10 sessions of driving simulator training or be placed in the no-training group.
Training group participants will visit the driving simulator lab 2-3 times a week for 4 weeks for training.
Paper-based tests and driving simulator tests will be done before and after 10 sessions of training (or a waiting period).

Full description

Driving is an important activity of daily living for most people in the United States, including older adults. It is an integral part of mobility, independent living, and physical, social, and economic well-being. Parkinson's disease is the second most common neurodegenerative disease, and it is an important societal issue and global priority. A recent survey study has reported that 84% of pwPD held a driving license. Among pwPD holding a driving license, 15% reported being involved in a motor vehicle crash in the past 3 years. Another study reported that among pwPD involved in motor vehicle crashes, 11% of them were at-fault collisions, which raises safety concerns among drivers with PD.5 Several studies have established that pwPD exhibit impaired driving skills evaluated on driving simulator experiments and on-road tests. Despite the challenges associated with driving in persons with Parkinson's disease, it is indicated that they can learn specific tasks but require more practice than healthy controls. In this study, we attempt to evaluate the training effectiveness of a portable driving simulator in improving cognitive performance, driver behavior, and aptitude in pwPD.

Enrollment

36 estimated patients

Sex

All

Ages

30+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Individuals with Parkinson's disease diagnosed by a movement disorder specialist.
Diagnosis of PD was based on the UK Brain Bank Diagnostic Criteria.
Hoehn and Yahr stage 1 to 3 in the medication ON state with no troublesome dyskinesia.
Minimum binocular acuity of 20/40 or better at least in one eye according to the Kansas DMV statutes.
Montreal Cognitive Assessment (MoCA) ≥ 20.
Ambulates independently with or without walking aids.
Possess a valid driver's license.

Exclusion criteria

Any concomitant neurological comorbidity, such as stroke, traumatic brain injury, or multiple sclerosis, that would hinder driving.
Atypical forms of Parkinsonism
History of substance abuse in the last 10 years.
History of uncontrolled psychiatric problems
Undergone deep brain stimulation or focused ultrasound treatment
Uncontrolled diabetes mellitus