Mild Cognitive ImpairmentNCT04648735
Driving Evaluation and Fitness for Persons With Cognitive Impairments
A study testing driving evaluation and practice in people with Mild Cognitive Impairment and Dementia, Mild, run by National Cheng Kung University.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment, Dementia, Mild, Driving Impaired
- What is being tested?
- driving evaluation and practice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2015to 31 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
Read the 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.
- Conditions
- Mild Cognitive Impairment, Dementia, Mild, Driving Impaired, Drive
- Being tested
- driving evaluation and practice
- Keywords
- Mild Cognitive Impairment, dementia, driving fitness, driving rehabilitation
- Medical subject headings
- Cognitive Dysfunction, Dementia, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
driving evaluation and practiceOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Drivers with cognitive impairments | Experimental | 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. Receives: Other: driving evaluation and practice |
| drivers with normal cognition | Active comparator | 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. Receives: Other: driving evaluation and practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The participant was scored immediately after practices.
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
Measured: during the practices
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.
Measured: during the practices
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2020
- Study start1 Aug 2015
- Primary completion31 Jul 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- an observational, cross-sectional research design
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng Kung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ling-Hui Chang, National Cheng Kung University
- Investigators
- Ling-Hui Chang, Ph.D, Principal investigator, Department of Occupational Therapy, NCKU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04648735
- Sponsor's protocol ID
- National ChengKung University
- Status last verified
- Dec 2020
- First submitted
- 22 Nov 2020
- Last updated
- 4 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cheng YH, Pai MC, Shih BH, Jan SS, Lin CY, Chang LH. Driving practice effects for older drivers with mild cognitive impairment: A preliminary study. Scand J Occup Ther. 2023 May;30(4):550-558. doi: 10.1080/11038128.2023.2184420. Epub 2023 Mar 11.
PubMed 36905632
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Driving Evaluation and Fitness for Persons With Cognitive Impairments
- ClinicalTrials.gov ID
- NCT04648735
- Acronym / sponsor ID
- National ChengKung University
- Conditions
- Mild Cognitive Impairment, Dementia, Mild, Driving Impaired, Drive
- Keywords
- Mild Cognitive Impairment, dementia, driving fitness, driving rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- National Cheng Kung UniversityUniversity, hospital or other
- Study start
- 1 Aug 2015 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 1 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- an observational, cross-sectional research design
| Arm | Type | Receives |
|---|---|---|
| Drivers with cognitive impairments | Experimental | Other: driving evaluation and practiceThe 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. |
| drivers with normal cognition | Active comparator | Other: driving evaluation and practiceThe 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| driving evaluation and practiceThe 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. | Other | Drivers with cognitive impairments, drivers with normal cognition |
Primary outcome
driving evaluation
Time frame: The participant was scored immediately after practices.
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
Time frame: during the practices
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
Time frame: during the practices
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2020.
- Derived from this study: PubMed 36905632Cheng YH, Pai MC, Shih BH, Jan SS, Lin CY, Chang LH. Driving practice effects for older drivers with mild cognitive impairment: A preliminary study. Scand J Occup Ther. 2023 May;30(4):550-558. doi: 10.1080/11038128.2023.2184420. Epub 2023 Mar 11.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ling-Hui Chang, Ph.D principal investigator
Department of Occupational Therapy, NCKU
Questions about this trial
What is this clinical trial studying?
A study testing driving evaluation and practice in people with Mild Cognitive Impairment and Dementia, Mild, run by National Cheng Kung University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
driving evaluation (time frame: The participant was scored immediately after practices.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04648735, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2020.