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Driving Evaluation and Fitness for Persons With Cognitive Impairments

Primary Purpose

Mild Cognitive Impairment, Dementia, Mild, Driving Impaired

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
driving evaluation and practice
Sponsored by
National Cheng Kung University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Mild Cognitive Impairment focused on measuring Mild Cognitive Impairment, dementia, driving fitness, driving rehabilitation

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria

  • age of at least 50 years
  • possession of a valid driving license and driving experience for at least 15 years
  • regular driving habit, defined as at least once a week, and
  • no reported significant driving issues

Exclusion Criteria

  • reported health conditions that could potentially compromise driving competence, such as stroke, Parkinson's disease or other neuromuscular diseases
  • visual impairments without correction, or
  • physical impairments found in physical function assessments

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Drivers with cognitive impairments

    drivers with normal cognition

    Arm Description

    The participants firstly completed a questionnaire of driving history and perceived driving competence, followed with a clinical physical and cognitive-perceptual assessment battery conducted by an occupational therapist to note any potential deficits that might affect driving performance. The participants, on a separate visit, completed three practice runs of a closed-circuit standardized course that included 8 driving maneuvers, followed by an on-road driving in the community fir 30 minutes.

    The participants firstly completed a questionnaire of driving history and perceived driving competence, followed with a clinical physical and cognitive-perceptual assessment battery conducted by an occupational therapist to note any potential deficits that might affect driving performance. The participants, on a separate visit, completed three practice runs of a closed-circuit standardized course that included 8 driving maneuvers, followed by an on-road driving in the community fir 30 minutes.

    Outcomes

    Primary Outcome Measures

    driving evaluation
    The driving evaluation follows the same format of the governmental on-road driving tests in Taiwan. The test included 8 driving maneuvers on a standardized driving course: pre-drive checks and actions before starting to drive, crosswalk crossing, railway crossing, parking in reverse, parallel parking at roadside, driving forward and backward on a curving road (S-bend), ascending and descending slope, driving around the test circuit. https://tpcmv.thb.gov.tw/english/ServicesEng/LicenseEng/LicenseTest/t03.htm The participants were scored according to governmental driving licensure exam guidelines. Scoring on individual driving maneuver is weighted. Depending on the type of error, 8, 16 or 32 points were deducted from 100, for example, 32 points for getting too close to pedestrian lane. The minimal score is 0 and the maximal score is 100. Higher scores means better performance.
    control of steering wheel
    An Android smart phone (LG Nexus 5) was used to record on-road driving behaviors. The phone was equipped with a global positioning system (GPS) mobile application, J device. J device compiled the accelerator, gyroscope, and GPS data at a frequency of 50 Hz. The J device gyroscope data showed changes in driving direction, indicating whether the driver's control of the steering wheel was steady. Lower numbers in gyroscope data meant that the steering wheel was moved little, thus indicating few changes in direction or steadier hands on the steering wheel
    control of speed
    An Android smart phone (LG Nexus 5) was used to record on-road driving behaviors. The phone was equipped with a global positioning system (GPS) mobile application, J device (Tsao et al., 2015). J device compiled the accelerator, gyroscope, and GPS data at a frequency of 50 Hz. The J device accelerator data represented changes in the speed of the car, indicating the degree of control the driver had over the accelerator and brake; i.e., whether the driver maintained a steady speed or caused frequent changes in speed. A lower number of accelerations meant that the driver had smaller acceleration changes in a set period of time, indicating a more constant speed and thus better accelerator and brake control. A higher number of accelerations meant that the driver had larger acceleration changes in a set period of time, indicating greater variation in speed and less control of the accelerator and brake.

    Secondary Outcome Measures

    Full Information

    First Posted
    November 22, 2020
    Last Updated
    December 2, 2020
    Sponsor
    National Cheng Kung University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04648735
    Brief Title
    Driving Evaluation and Fitness for Persons With Cognitive Impairments
    Official Title
    Driving Evaluation and Fitness for Persons With Cognitive Impairments
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    August 1, 2015 (Actual)
    Primary Completion Date
    July 31, 2018 (Actual)
    Study Completion Date
    July 31, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    National Cheng Kung University

    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
    Driving is an important activity for older adults because it frequently relates to personal independence and wellbeing. This study compared the driving behaviors of older drivers with normal cognition and with MCI in unfamiliar driving situations and difficult maneuvers, and explored the practice effect on driving performance of drivers with MCI. This study used an observational, cross-section research design.
    Detailed Description
    Driving is an important activity for older adults because it is frequently related to personal independence, mobility, social interaction, wellbeing, and confidence. Dementia can impair older adults' driving. The current consensus is that people with moderate or severe dementia are too cognitively impaired to drive safely. Persons with Mild Cognitive Impairment (MCI), often considered a transitional state to dementia, and those with mild dementia can still potentially drive, although some require further evaluation to determine the driver's fitness to drive. Extensive research has been devoted to the development of fitness-to-drive assessments. However, very limited attention has been paid to whether the driving skills of drivers with MCI can improve and thus potentially prolong the driver's safe-driving years. MCI is a common neurodegenerative disease in older adults, with a prevalence of 16-20%. It is estimated that 20-40% of the MCI population will progress to dementia. Despite the potential driving concerns, it should be noted that over 50% of people with MCI are considered safe drivers. Because un-warranted driving cessation may lead to depression, functional decline, and even increases in the family's care burden, researchers have guarded against the premature revocation of driving rights. Recent studies exploring the driving behaviors of drivers with MCI have shown inconsistent results. For example, increasing difficulties and unsafe behaviors in driving can be considered early warning signs of possible cognitive impairment. There may be a connection between specific cognitive skills (such as flexibility of visual attention and executive functioning) and poorer driving performance on specific tasks, such as car-following and road-tracking. Drivers with MCI may encounter difficulties at intersections with stop signs or critical light changes, and with headway, driving speed, reaction time, and lateral control. However, the above studies were usually conducted with driving simulators. Only a few studies have investigated the on-road driving performance of drivers with MCI. Wadley, et al. compared drivers with MCI to drivers with normal cognition on a standardized route with various driving maneuvers frequently encountered in daily life. The results showed "less than optimal" performance, such as statistically significant poor performances in overall driving skills, especially in lane control and left turns. Driving can become increasingly difficult, for the cognitive capacities of older drivers with MCI are likely to deteriorate over time. Recent evidence has suggested that cognitive training can slow or even reverse the cognitive impairments associated with MCI. Cognition intervention have shown positive improvements in the immediate and delayed memory functions of persons with MCI after intervention. However, advances in cognitive training for persons with MCI have yet to be applied to driver rehabilitation. Driving rehabilitation includes both screening for unsafe drivers and the provision of individually-tailored interventions for clients with disabilities or those with a recent health event. Older drivers with cognitive impairments, such as dementia, are frequently the focus of driver screening. The current literature on driving training or retraining, however, has focused on other client populations, such as stroke, traumatic head injuries, and spinal cord injuries, and excluded those with cognitive impairments or not included screening for cognitive impairments. Even though systematic reviews by Korner-Bitensky et al. (2009) and Unsworth et al. (2014) support that driver rehabilitation improves the on-road driving performance of older drivers, older drivers with MCI are rarely considered targets for driver re-training. This finding is surprising because the driving skills of drivers with MCI can be compromised. Drivers with MCI can potentially benefit most from driving re-education, yet few studies have discussed issues related to driving training of older drivers with MCI. In short, it is imperative to maintain the independence of persons with cognitive impairments for as long as possible. Without intervention, the driving competence of persons with MCI is likely to deteriorate as the disease and age progress. This study is to explore this possibility by examining how drivers with MCI perform as compared to drivers with normal cognition when negotiating a new route and whether learning effects would manifest if the drivers were given opportunities to practice.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mild Cognitive Impairment, Dementia, Mild, Driving Impaired, Drive
    Keywords
    Mild Cognitive Impairment, dementia, driving fitness, driving rehabilitation

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    an observational, cross-sectional research design
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    the participant and the outcome assessor were both blind to the design.
    Allocation
    Non-Randomized
    Enrollment
    41 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Drivers with cognitive impairments
    Arm Type
    Experimental
    Arm Description
    The participants firstly completed a questionnaire of driving history and perceived driving competence, followed with a clinical physical and cognitive-perceptual assessment battery conducted by an occupational therapist to note any potential deficits that might affect driving performance. The participants, on a separate visit, completed three practice runs of a closed-circuit standardized course that included 8 driving maneuvers, followed by an on-road driving in the community fir 30 minutes.
    Arm Title
    drivers with normal cognition
    Arm Type
    Active Comparator
    Arm Description
    The participants firstly completed a questionnaire of driving history and perceived driving competence, followed with a clinical physical and cognitive-perceptual assessment battery conducted by an occupational therapist to note any potential deficits that might affect driving performance. The participants, on a separate visit, completed three practice runs of a closed-circuit standardized course that included 8 driving maneuvers, followed by an on-road driving in the community fir 30 minutes.
    Intervention Type
    Other
    Intervention Name(s)
    driving evaluation and practice
    Intervention Description
    The participants completed the actual driving with a licensed driving instructor on the passenger side in the car and with a dual-control, automatic-transmission car. Each participant completed three runs of the same route. The first twos were practices to familiarize themselves with the course. The driving instructor graded them on the third run. Each trial took about 10 minutes. The participants were scored according to governmental driver test guidelines. Scoring on individual driving maneuver is weighted. Depending on the type of error, 8, 16 or 32 points were deducted from 100, for example, 32 points for getting too close to pedestrian lane, running a red light or railroad crossing, and 8 points for stopping in S-curve forward and backward. 70 or above is considered as a pass. The occupational therapists in the backseat recorded driving behaviors, including whether the driver checked rear and side mirrors, excessive sweating, distractibility, number of adjustments, etc.
    Primary Outcome Measure Information:
    Title
    driving evaluation
    Description
    The driving evaluation follows the same format of the governmental on-road driving tests in Taiwan. The test included 8 driving maneuvers on a standardized driving course: pre-drive checks and actions before starting to drive, crosswalk crossing, railway crossing, parking in reverse, parallel parking at roadside, driving forward and backward on a curving road (S-bend), ascending and descending slope, driving around the test circuit. https://tpcmv.thb.gov.tw/english/ServicesEng/LicenseEng/LicenseTest/t03.htm The participants were scored according to governmental driving licensure exam guidelines. Scoring on individual driving maneuver is weighted. Depending on the type of error, 8, 16 or 32 points were deducted from 100, for example, 32 points for getting too close to pedestrian lane. The minimal score is 0 and the maximal score is 100. Higher scores means better performance.
    Time Frame
    The participant was scored immediately after practices.
    Title
    control of steering wheel
    Description
    An Android smart phone (LG Nexus 5) was used to record on-road driving behaviors. The phone was equipped with a global positioning system (GPS) mobile application, J device. J device compiled the accelerator, gyroscope, and GPS data at a frequency of 50 Hz. The J device gyroscope data showed changes in driving direction, indicating whether the driver's control of the steering wheel was steady. Lower numbers in gyroscope data meant that the steering wheel was moved little, thus indicating few changes in direction or steadier hands on the steering wheel
    Time Frame
    during the practices
    Title
    control of speed
    Description
    An Android smart phone (LG Nexus 5) was used to record on-road driving behaviors. The phone was equipped with a global positioning system (GPS) mobile application, J device (Tsao et al., 2015). J device compiled the accelerator, gyroscope, and GPS data at a frequency of 50 Hz. The J device accelerator data represented changes in the speed of the car, indicating the degree of control the driver had over the accelerator and brake; i.e., whether the driver maintained a steady speed or caused frequent changes in speed. A lower number of accelerations meant that the driver had smaller acceleration changes in a set period of time, indicating a more constant speed and thus better accelerator and brake control. A higher number of accelerations meant that the driver had larger acceleration changes in a set period of time, indicating greater variation in speed and less control of the accelerator and brake.
    Time Frame
    during the practices

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion criteria age of at least 50 years possession of a valid driving license and driving experience for at least 15 years regular driving habit, defined as at least once a week, and no reported significant driving issues Exclusion Criteria reported health conditions that could potentially compromise driving competence, such as stroke, Parkinson's disease or other neuromuscular diseases visual impairments without correction, or physical impairments found in physical function assessments
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ling-Hui Chang, Ph.D
    Organizational Affiliation
    Department of Occupational Therapy, NCKU
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Driving Evaluation and Fitness for Persons With Cognitive Impairments

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