Portable Driving Simulator for PD Assessment (NCT03969927)

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Portable Driving Simulator for PD Assessment (NCT03969927)

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Portable Driving Simulator for Parkinson's Disease Assessment (NCT03969927)

Overview

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Portable Driving Simulator for Parkinson's Disease Assessment (NCT03969927)

Overview

Mermaid diagram (expand to render)

NCT03969927 is an observational study evaluating the validity and reliability of a portable driving simulator for assessing driving ability in individuals with neurological conditions including Parkinson's disease, stroke, and multiple sclerosis. The study compares a low-fidelity portable driving simulator (PDS) against a high-fidelity fixed-base simulator to determine whether portable devices can provide adequate assessment capabilities for clinical and research purposes.

This research addresses a critical need in neurorehabilitation: the ability to objectively assess driving fitness in patients with neurological conditions who may be at increased risk for driving-related accidents. [@akinwuntan2019] Traditional driving assessments require expensive simulator equipment or on-road testing, limiting accessibility. Portable simulators could enable more widespread screening and follow-up evaluation. [@akinwuntan2019]

Trial Details

| Attribute | Value |
|-----------|-------|
| NCT Number | NCT03969927 |
| Status | Recruiting (as of August 2024) |
| Study Type | Observational |
| Conditions | Parkinson's Disease, Stroke, Multiple Sclerosis |
| Interventions | Low-Fidelity Portable Driving Simulator vs. High-Fidelity Fixed-Base Simulator |
| Sponsor | University of Kansas Medical Center |
| Principal Investigator | Abiodun E. Akinwuntan, PhD |
| Start Date | August 28, 2019 |
| Estimated Completion | June 30, 2025 |
| Enrollment | Not specified |

Research Objectives

Primary Objectives

Validate Portable Simulator: Determine whether a low-fidelity portable driving simulator can provide valid measurements of driving performance compared to high-fidelity systems

Assess Usability: Evaluate user-friendliness of the portable device across different patient populations

Measure Simulator Sickness: Assess the incidence and severity of simulator sickness symptoms with portable vs. fixed-base systems

Secondary Objectives

Compare Driving Metrics: Evaluate lane position maintenance, speed adherence, traffic light reaction times, and overall reaction time between simulator types

Establish Reliability: Determine test-retest reliability of the portable simulator

Population-Specific Analysis: Compare performance across Parkinson's disease, stroke, and multiple sclerosis groups

Outcome Measures

Primary Outcomes

| Measure | Description |
|---------|-------------|
| User-Friendliness | Likert scale (1-5) assessing ease of use and participant satisfaction |
| Simulator Sickness | Simulator Sickness Questionnaire (SSQ) scoring range 0-228.14 |
| Driving Performance | Composite score including lane position, speed adherence, traffic light reaction, and reaction time |

Secondary Outcomes

Comparison of individual driving metrics between simulator types
Correlation analysis between portable and high-fidelity measurements
Subgroup analysis by neurological condition

Study Design

Methodology

The study employs a cross-sectional, within-subjects design where each participant completes driving tasks on both the portable and high-fidelity simulators. This approach allows direct comparison of the two assessment methods within the same individual, controlling for between-subject variability.

Assessment Components

Baseline Assessment: Demographics, medical history, driving history

Cognitive Screening: Mini-Mental State Examination (MMSE) score ≥24 required for eligibility

Vision Testing: Binocular acuity at least 20/60

Driving Tasks: Standardized scenarios including lane keeping, speed regulation, traffic light response, and hazard detection

Eligibility Criteria

Inclusion Criteria

Adults aged 25-75 years
Diagnosis of Parkinson's disease, stroke, or multiple sclerosis
Valid driver's license for at least 3 years
MMSE score ≥24 (cognitive eligibility)
Binocular visual acuity at least 20/60

Exclusion Criteria

Severe motor impairment preventing simulator interaction
Active medical conditions contraindicated for driving
Prior participation in this study
Inability to provide informed consent

Significance for Parkinson's Disease

Driving assessment is particularly relevant for Parkinson's disease patients due to several disease-specific factors:

Motor Impairment Impact

Bradykinesia and rigidity can affect reaction time and vehicle control
Tremor may interfere with steering wheel manipulation
Postural instability can compromise emergency maneuver execution

Cognitive Factors

Executive dysfunction affects decision-making and divided attention
Visual processing deficits may impair hazard recognition
Memory impairments can affect navigation and task sequencing

Medication Effects

Dopaminergic medications may cause daytime sleepiness
On-off fluctuations can create unpredictable driving capability
Dyskinesias may interfere with safe vehicle operation

Research Implications

A validated portable driving simulator could:

Enable remote monitoring of driving fitness in PD patients
Provide objective data for clinical driving recommendations
Facilitate tracking of disease progression impact on driving
Support rehabilitation interventions targeting driving-specific skills

Simulator Technology Comparison

Portable Driving Simulator (PDS) Specifications

The low-fidelity portable driving simulator under evaluation includes:

| Component | Specification |
|-----------|---------------|
| Display | Laptop or tablet screen (12-15 inch) |
| Controls | Keyboard-based or basic joystick |
| Software | Custom driving scenario software |
| Setup Time | < 10 minutes |
| Portability | Fits in standard carrying case |
| Cost | < $5,000 |

High-Fidelity Fixed-Base Simulator

The comparison system includes:

| Component | Specification |
|-----------|---------------|
| Display | Multi-screen immersive display (180°+ field of view) |
| Controls | Force-feedback steering wheel, brake/acceleration pedals |
| Motion | Platform with 3-6 degrees of freedom motion |
| Software | Full physics engine with realistic vehicle dynamics |
| Setup Time | 30-60 minutes |
| Space | Dedicated room required |
| Cost | $100,000-500,000 |

Key Differences for Assessment

The fundamental differences between portable and high-fidelity systems affect their utility:

Visual Fidelity: Portable simulators use 2D displays while high-fidelity systems provide immersive 3D environments

Control Fidelity: Basic input devices cannot replicate the tactile feedback of real vehicle controls

Motion Cues: Portable systems lack motion feedback that contributes to driving immersion

Scenarios: Portable systems offer fewer and simpler driving scenarios

However, for basic assessment metrics like lane position, reaction time, and speed maintenance, portable systems may provide adequate validity.

Driving Assessment Metrics

Lane Position Maintenance

This metric evaluates the driver's ability to maintain proper lane positioning:

Measure: Standard deviation of lateral lane position
Units: Meters from lane center
PD Relevance: Impaired by bradykinesia affecting steering corrections and visual-spatial deficits

Speed Adherence

Compliance with speed limits and appropriate speed selection:

Measure: Deviation from posted speed limit, speed variability
Units: km/h or mph
PD Relevance: Affected by impaired judgment, bradykinesia in acceleration/deceleration

Traffic Light Reaction

Response time and accuracy when approaching traffic signals:

Measure: Reaction time from light change to brake application
Units: Seconds
PD Relevance: Delayed by bradykinesia, impaired visual processing, cognitive slowing

Hazard Detection

Recognition and response to unexpected road hazards:

Measure: Time to detection, avoidance maneuvers
Units: Seconds, response accuracy
PD Relevance: Compromised by reduced divided attention, executive dysfunction

Overall Reaction Time

Composite measure of cognitive and motor response:

Measure: Complex reaction time tasks
Units: Milliseconds
PD Relevance: Significantly prolonged in PD due to combined cognitive-motor impairment

Clinical Implementation Pathway

Phase 1: Validation (Current Study)

Compare PDS metrics against gold-standard high-fidelity simulator
Establish correlation coefficients for each metric
Determine measurement error and reliability

Phase 2: Population Norms

Collect normative data from healthy controls across age groups
Establish cut-off scores for driving fitness
Account for learning effects with repeated testing

Phase 3: Clinical Integration

Develop decision algorithm for driving recommendation
Create screening protocols for clinicians
Establish retesting intervals for disease progression monitoring

Phase 4: Remote Assessment

Enable at-home monitoring with consumer-grade equipment
Track longitudinal changes in driving fitness
Alert clinicians to concerning trends

Regulatory and Safety Considerations

Driving Fitness Assessment in PD

In most jurisdictions, driving is regulated but not systematically monitored:

Self-Reporting: Patients typically must report medical conditions
Physician Reporting: Varies by jurisdiction (some have mandatory reporting)
Practical Testing: Often only triggered by accidents or incidents

Portable simulators could provide objective monitoring between clinical visits.

Simulator Sickness Considerations

Simulator sickness is a significant concern that can affect both assessment validity and participant safety:

Symptoms:

Nausea and vomiting
Dizziness and disorientation
Headache
Visual discomfort

PD-Specific Concerns:

Patients with autonomic dysfunction may be more susceptible
Baseline dizziness from PD medications may compound effects
Need for pre-screening for history of motion sickness

Future Directions

Technology Evolution

Portable driving assessment technology is advancing rapidly:

Virtual Reality Integration: VR headsets provide immersive experience with portable devices

Smartphone Compatibility: Phone-based assessment becoming feasible

AI-Powered Analysis: Machine learning for automated performance scoring

Biometric Integration: Heart rate, eye tracking for comprehensive assessment

Clinical Research Applications

Validated portable simulators could enable:

Multi-Site Trials: Standardized assessment across geographic locations
Longitudinal Monitoring: Track driving changes over disease progression
Intervention Studies: Measure effects of medications or rehabilitation
Telehealth Integration: Remote assessment for patients with mobility limitations

Driving Assessment in Parkinson's Disease

The Clinical Need for Driving Assessment

Driving is a complex instrumental activity of daily living that significantly impacts independence, quality of life, and employment for individuals with Parkinson's disease. The progressive nature of PD eventually compromises the motor, cognitive, and visual abilities essential for safe vehicle operation. Approximately 25-50% of individuals with PD eventually cease driving, with driving cessation occurring on average 3-5 years after diagnosis, though significant variability exists based on disease severity, comorbidities, and individual circumstances.

The loss of driving privileges has profound consequences:

Functional Impact:

Reduced independence in daily activities
Increased reliance on family members or public transportation
Limited access to healthcare appointments, social activities, and community engagement
Potential loss of employment for younger patients

Psychological Impact:

Depression and anxiety related to loss of independence
Reduced self-esteem and sense of self-efficacy
Social isolation and withdrawal
Family strain due to increased caregiving demands

Economic Impact:

Annual cost of PD-related driving cessation estimated at $10,000-20,000 per patient
Increased healthcare costs due to transportation barriers
Lost productivity for patients and caregivers

Why Driving Ability Declines in PD

Multiple PD-related factors impair driving ability:

Motor Symptoms:

Bradykinesia affects reaction time and physical responses
Rigidity limits neck rotation and mirror checking
Tremor interferes with steering wheel control
Postural instability compromises emergency maneuvers
Freezing of gait can occur while driving

Cognitive Symptoms:

Executive dysfunction impairs decision-making and divided attention
Visual-spatial deficits affect lane positioning and hazard detection
Memory impairment may affect route navigation
Attention deficits reduce ability to process multiple stimuli
Psychomotor slowing extends reaction times

Visual Symptoms:

Reduced contrast sensitivity affects low-light driving
Color vision deficits may impair traffic signal recognition
Diplopia (double vision) can occur with PD medications
Visual field defects may reduce hazard awareness

Non-Motor Symptoms:

Daytime sleepiness from PD or medications
Orthostatic hypotension causes dizziness
Anxiety and panic can impair driving

Medication Effects:

Dopaminergic medications can cause sudden "off" periods
Dyskinesias may interfere with vehicle control
Sleep attacks (sudden onset of sleep) are rare but dangerous

Current Assessment Methods

Currently available driving assessment methods include:

On-Road Testing:

Gold standard but resource-intensive
Requires certified examiner and appropriate vehicle
Not available in all regions
May not be covered by insurance
Can be stressful for patients

High-Fidelity Simulation:

Excellent validity but cost-prohibitive
Requires dedicated space and equipment
Not portable or accessible
Limited availability at specialized centers

Paper-Based Tests:

Useful screening tools but do not assess actual driving
Examples: Trail Making Test, Useful Field of View
Do not capture the integration of skills needed for driving

Self and Caregiver Reports:

Subjective and potentially unreliable
May underreport or overreport difficulties
Useful but not sufficient alone

The Promise of Portable Simulation

Portable driving simulators offer a middle ground:

Advantages:

More valid than paper tests (includes actual driving behavior)
More accessible than high-fidelity simulators
Lower cost allows wider deployment
Can be used in community settings
Enables longitudinal monitoring
Can be deployed in patient's home

Challenges:

Lower fidelity than fixed simulators
May not replicate all driving scenarios
Learning effects with repeated testing
Technical reliability concerns

The NCT03969927 Trial Design

Study Methodology

The trial employs a cross-sectional, within-subjects design:

Design Rationale:

Each participant serves as their own control
Eliminates between-subject variability
Requires smaller sample size
Allows direct comparison of simulator types

Procedure:

Participants complete driving tasks on both simulators
Order randomized to control for order effects
Adequate washout between sessions
Same scenarios presented on both systems

Assessment Environment:

Standardized lighting conditions
Consistent instructions
Trained research staff present
Same cognitive screening conducted

Task Scenarios

Lane Keeping:

Standard highway driving scenario
Maintain position in lane
No other traffic
3-5 minute duration

Speed Regulation:

Variable speed limit zones
Maintain appropriate speed
Smooth acceleration/deceleration
3-5 minute duration

Traffic Light Response:

Intersections with signal changes
Stop on red, proceed on green
Yellow light decisions
5-10 scenarios

Hazard Detection:

Pedestrians entering road
Vehicles merging
Road debris
Unexpected obstacles

Complex Reaction Time:

Multiple stimuli presented
Varied response requirements
Measures cognitive processing speed

Data Quality Assurance

Training:

Research staff trained on both systems
Standardized instructions
Consistent prompts

Monitoring:

Real-time observation during testing
Technical issues recorded
Data integrity checks

Participant Instructions:

Clear explanation of tasks
Practice trials before data collection
Encouragement to do their best

Scientific Validation

Validation Metrics

The trial assesses multiple types of validity:

Concurrent Validity:

Correlation between portable and high-fidelity metrics
Expected: moderate to high correlation (r > 0.5)
Different metrics may have different validity

Construct Validity:

Do metrics measure the intended constructs?
Comparison with established measures
Known-groups validity (PD vs. controls)

Predictive Validity:

Do simulator metrics predict on-road performance?
More difficult to assess (requires on-road testing)
May be assessed in future studies

Expected Outcomes

Based on prior research, we expect:

High Correlation Metrics:

Lane position standard deviation
Speed maintenance
Simple reaction time

Lower Correlation Metrics:

Complex scenario responses
Hazard detection
Real-world judgment

Reliability Assessment

Test-Retest Reliability:

Important for longitudinal monitoring
Expected: moderate to high reliability
Learning effects may affect reliability

Internal Consistency:

Do metrics correlate within domains?
Different aspects of driving may cluster

Clinical Translation

Implementing Portable Assessment

If the portable simulator proves valid, implementation pathways include:

Phase 1: Clinical Validation

Establish cut-off scores for safety concerns
Validate against on-road performance
Develop interpretation guidelines

Phase 2: Clinical Integration

Integrate into movement disorder clinics
Train clinicians on interpretation
Develop decision algorithms

Phase 3: Patient Monitoring

Enable at-home periodic assessment
Track changes over disease progression
Alert clinicians to concerning trends

Decision Algorithms

Clinicians need clear guidance:

Algorithm Components:

Baseline assessment at diagnosis

Periodic screening (annually or biannually)

Triggered assessment (after significant change)

Clear referral criteria for on-road testing

Considerations:

Must balance safety with autonomy
Consider patient and family preferences
Account for regional regulations
Document decision-making process

Ethical Considerations

Driving assessment raises important ethical issues:

Autonomy:

Patients have right to make decisions
But safety of self and others is paramount
Need transparent discussion of risks

Confidentiality:

Assessment results may affect insurance
Must maintain appropriate confidentiality
Understand mandatory reporting requirements

Justice:

Assessment should be accessible
Not create barriers for underserved populations
Consider costs and resources

Regulatory Framework

Reporting Requirements:

Vary by jurisdiction
Some areas require physician reporting
Many areas rely on self-reporting
Portable assessment may enhance monitoring

Licensing:

Most jurisdictions require periodic renewal
Medical conditions must be reported
May require functional assessment
Appeals process for license revocation

Future Directions

Technology Evolution

Driving assessment technology continues to evolve:

Virtual Reality (VR):

More immersive experience with portable devices
Better engagement and realism
Costs decreasing rapidly
Validation studies needed

Smartphone Applications:

Most accessible option
Uses phone sensors for basic assessment
Limited but rapidly improving
Good for screening, not full assessment

Machine Learning:

Automated analysis of driving behavior
Pattern recognition for safety concerns
May identify subtle warning signs
Requires validation

Biometric Integration:

Heart rate variability
Eye tracking
Brain-computer interfaces
May detect fatigue or distraction

Research Priorities

Key questions for future investigation:

Predictive Validity: How well do simulator metrics predict on-road performance?

Longitudinal Tracking: Can simulators track change over time?

Intervention Effects: Can simulators measure treatment response?

Population Norms: What are normal ranges by age and condition?

Telehealth: Can remote assessment be validated?

Integration with Clinical Care

Portable simulators could transform care:

Annual Screening:

Part of routine PD management
Track changes over time
Trigger intervention when needed

Pre-Treatment Assessment:

Baseline before medication changes
Assess impact of new treatments
Guide rehabilitation

Rehabilitation Monitoring:

Track response to driving rehabilitation
Identify areas for intervention
Motivate patients with progress data

Technical Specifications

Portable Simulator Components

Hardware Requirements:

Laptop or tablet computer (12-15 inch minimum)
Keyboard with arrow keys or basic joystick
Stable mounting surface
Quiet environment

Software Requirements:

Custom driving scenario software
Data collection and storage
Basic analytics
Secure data transfer

Physical Specifications:

Weight: <5 kg (portable)
Dimensions: fits in standard case
Setup time: <10 minutes
Power: standard electrical outlet

Validation Protocol Details

Testing Environment:

Controlled lighting (not direct sunlight)
Minimal external distractions
Comfortable temperature
Quiet environment

Participant Preparation:

Review instructions thoroughly
Practice session (not scored)
Comfortable seating position
Correct screen distance/angle

Data Collection:

Continuous recording of metrics
Session metadata (time, date, duration)
Technical issues logged
Backup data storage

Data Management

Privacy Considerations:

HIPAA-compliant storage
Limited access controls
Secure transmission protocols
Data retention policies

Quality Control:

Automatic range checks on data
Manual review of outliers
Inter-rater reliability for subjective metrics
Regular equipment calibration

Comparative Analysis

Portable vs. Fixed Simulators

| Feature | Portable | Fixed (High-Fidelity) |
|---------|----------|----------------------|
| Initial Cost | <$5,000 | $100,000-500,000 |
| Space Required | Small | Dedicated room |
| Setup Time | <10 min | 30-60 min |
| Portability | High | None |
| Visual Fidelity | 2D display | 180°+ immersive |
| Control Fidelity | Basic keyboard/joystick | Force-feedback wheel |
| Motion Cues | None | 3-6 DOF motion |
| Validity for Basic Metrics | Moderate-high | High |
| Validity for Complex Scenarios | Lower | Higher |

Simulator vs. On-Road Testing

| Feature | Simulator | On-Road |
|---------|-----------|---------|
| Standardization | High | Variable |
| Safety | Very high | Some risk |
| Cost per Assessment | Low | High |
| Availability | Widespread | Limited |
| Validity | Good for basic | Excellent |
| Real-World Transfer | Moderate | Excellent |
| Legal Admissibility | Limited | Strong |

Driving Assessment in Other Conditions

The validation approach used in this trial may be applicable to other neurological conditions:

Stroke:

Similar assessment needs
Different specific impairments
May benefit from portable monitoring

Multiple Sclerosis:

Variable disease course
Fatigue affects driving
Portable assessment could help

Traumatic Brain Injury:

Cognitive impairment is key
Assessment important for return to driving
Portable tools may assist

Dementia (Non-AD):

Vascular dementia, Lewy body dementia
Driving safety concerns
May benefit from monitoring

Implementation Challenges

Technical Limitations

Fidelity Constraints:

Cannot replicate all real-world scenarios
Limited visual detail
Missing motion cues
May not trigger all driving behaviors

Learning Effects:

Performance improves with practice
Need adequate washout between sessions
Repeated testing requires adjustment

Technical Issues:

Equipment reliability
Software bugs
Data quality
Maintenance requirements

Patient Factors

Computer Literacy:

Some patients unfamiliar with technology
May affect performance independent of driving ability
Training may be needed

Physical Limitations:

Cannot use standard controls
Visual limitations
Tremor affecting input devices

Motivation:

May not take assessment seriously
Practice effects if motivated
Fatigue affecting performance

Clinical Integration

Workflow:

Training staff on use
Time in clinic schedule
Data interpretation
Reporting to patients

Reimbursement:

Coverage for assessment
Billing codes unclear
May require advocacy

Legal Concerns:

Documentation standards
Liability for adverse events
Reporting requirements

[Parkinson's Disease](/diseases/parkinsons-disease) — Main disease page](/proteins/parkin)
[Driving and Parkinson's Disease](/therapies/rehabilitation/parkinsons-driving) — Related therapies](/proteins/parkin)
[Clinical Trials Dashboard](/clinical-trials/dashboard) — All PD clinical trials](/clinical-trials)
[Movement Disorders](/diseases/movement-disorders) — Related conditions

References

[Akinwuntan AE et al., Development and validation of a portable driving simulator (2019)](https://doi.org/10.1016/j.apmr.2019.01.021)

[NCT03969927 - ClinicalTrials.gov](https://clinicaltrials.gov/study/NCT03969927)

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📗 Cite This Artifact

Portable Driving Simulator for PD Assessment (NCT03969927)

Portable Driving Simulator for Parkinson's Disease Assessment (NCT03969927)

Overview

Portable Driving Simulator for Parkinson's Disease Assessment (NCT03969927)

Overview

Trial Details

Research Objectives

Primary Objectives

Secondary Objectives

Outcome Measures

Primary Outcomes

Secondary Outcomes

Study Design

Methodology

Assessment Components

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Significance for Parkinson's Disease

Motor Impairment Impact

Cognitive Factors

Medication Effects

Research Implications

Simulator Technology Comparison

Portable Driving Simulator (PDS) Specifications

High-Fidelity Fixed-Base Simulator

Key Differences for Assessment

Driving Assessment Metrics

Lane Position Maintenance

Speed Adherence

Traffic Light Reaction

Hazard Detection

Overall Reaction Time

Clinical Implementation Pathway

Phase 1: Validation (Current Study)

Phase 2: Population Norms

Phase 3: Clinical Integration

Phase 4: Remote Assessment

Regulatory and Safety Considerations

Driving Fitness Assessment in PD

Simulator Sickness Considerations

Future Directions

Technology Evolution

Clinical Research Applications

Driving Assessment in Parkinson's Disease

The Clinical Need for Driving Assessment

Why Driving Ability Declines in PD

Current Assessment Methods

The Promise of Portable Simulation

The NCT03969927 Trial Design

Study Methodology

Task Scenarios

Data Quality Assurance

Scientific Validation

Validation Metrics

Expected Outcomes

Reliability Assessment

Clinical Translation

Implementing Portable Assessment

Decision Algorithms

Ethical Considerations

Regulatory Framework

Future Directions

Technology Evolution

Research Priorities

Integration with Clinical Care

Technical Specifications

Portable Simulator Components

Validation Protocol Details

Data Management

Comparative Analysis

Portable vs. Fixed Simulators

Simulator vs. On-Road Testing

Driving Assessment in Other Conditions

Implementation Challenges

Technical Limitations

Patient Factors

Clinical Integration

Related Pages