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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30+
SponsorUniversity of Kansas Medical Center

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Low-fidelity driving simulator training

    Other intervention

    Participants in the treatment group will undergo 10 sessions of training on a low-fidelity driving simulator. Each session will last approximately 45-60 minutes. There will be 2-3 sessions each week for 4 weeks.

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: TrainingExperimental treatment 1 intervention
Group B: Waitlist controlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Driving performance - Standard Lane Deviation Position

SDLP refers to the mean Lane position of the driver's vehicle to the roadway centerline (defined as zero). The center of the vehicle is the reference point. Positive values indicate lane positions on the right side of the road; negative values indicate left. Default roadway lane widths are 12 ft (3.66 m) across; therefore, values close to 6 ft (1.83 m) indicate positioning near the center of a lane.

Time frame
Baseline (pre-intervention) and at 4 weeks (post-intervention)
2

Driving aptitude - The Adelaide Driving Self-Efficacy Scale

The Adelaide Driving Self-Efficacy Scale is a self-reported assessment of participants' beliefs in their capability to organize and execute actions towards safe driving. It is a 12-item questionnaire that measures an individual's self-perceived confidence in performing various driving-related activities, such as driving in heavy traffic or at night. It uses a 0 (not confident at all) to 10 (completely confident) rating scale for each activity, with total scores indicating overall driving confidence.

Time frame
Baseline (pre-intervention) and at 4 weeks (post-intervention)

Secondary outcomes

1

Cognitive performance - Montreal Cognitive Assessment

The Montreal Cognitive Assessment is a brief screening tool used to detect mild cognitive impairment and early dementia. It evaluates multiple cognitive domains, including attention, executive function, memory, language, visuospatial skills, abstraction, calculation, and orientation. Total score is 30 points. \> or = 26 ---- Normal 18 to 25 ----- Mild cognitive impairment

Time frame
Baseline (pre-intervention) and at 4 weeks (post-intervention)
2

Cognitive performance - Dot cancellation test errors

The Dot Cancellation Test is a neuropsychological evaluation tool used to assess focus, attention, visual scanning, and occasionally motor speed or neglect. It is also referred to as the Cancellation Test or Visual Cancellation Task. The participant is given a page with a random cluster of dots and instructed to cross out (cancel) a particular type of cluster of dots. The investigator calculates the time taken and the number of errors committed by the participant.

Time frame
Baseline (pre-intervention) and at 4 weeks (post-intervention)
3

Cognitive performance - Rey-Osterrieth Complex Figure Copy

The Rey-Rey-Osterrieth Complex Figure Copy Test is a neuropsychological tool used to assess visuospatial constructional ability, planning, and organizational skills. The individual is asked to copy a complex geometric figure, and their drawing is scored based on the accuracy and placement of 18 specific design components. The score ranges from 0 to 36. A higher score indicates better performance.

Time frame
Baseline (pre-intervention) and at 4 weeks (post-intervention)
4

Cognitive performance - Trail Making Tests A & B

The Trail Making Test is a paper-and-pencil assessment used to measure attention, processing speed, and executive function. It has two parts: TMT-A, where individuals connect numbers in sequence (1-25), primarily tests visual scanning and processing speed. TMT-B requires alternating between numbers and letters in order (1-A-2-B, etc.), placing greater demand on cognitive flexibility and set-shifting.

Time frame
Baseline (pre-intervention) and at 4 weeks (post-intervention)

Other outcomes

1

Daily Driving Log

A self-reported Daily Driving Log, manually entered in a journal by each participant, will be collected to analyze driving patterns during the study period.

Time frame
Baseline (pre-intervention) and at 4 weeks (post-intervention)

Sponsors and contacts

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