UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042525 |
|---|---|
| Receipt number | R000048332 |
| Scientific Title | Behavioral characteristics in driving for people with cognitive dysfunction compared to the general drivers |
| Date of disclosure of the study information | 2020/11/24 |
| Last modified on | 2025/02/28 17:16:30 |
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Basic information
Public title
Behavioral characteristics in driving for people with cognitive dysfunction compared to the general drivers
Acronym
Behavioral characteristics in driving for people with cognitive dysfunction compared to the general drivers
Scientific Title
Behavioral characteristics in driving for people with cognitive dysfunction compared to the general drivers
Scientific Title:Acronym
Behavioral characteristics in driving for people with cognitive dysfunction compared to the general drivers
Region
| Japan |
Condition
Condition
Healthy adults
cognitive dysfunction
Classification by specialty
| Neurology | Neurosurgery | Rehabilitation medicine |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparing the behavioral characteristics in driving between the general drivers and people with cognitive dysfunction.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Event data recorder score
Key secondary outcomes
Mini-Mental State Examination
Trail Making Test PartA, PartB
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Drive on the road using a training car, and measure the score of the event recorder with scoring function.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
<Healthy people>
1.Those who drive at least once a week
2.Those who have a driver's license
3.Those who give a written informed consent
<People with cognitive dysfunction>
Those who had evaluated at road test and agreed to provide the results
Key exclusion criteria
<Healthy people>
1.Motor paralysis
2.Have a history of Epilepsy
3.Difficult to walk and activity daily living is not independent
4.Have a history of cerebrovascular disease, traumatic brain injury, hypoxic encephalopathy, encephalitis, and brain tumor
5.Mini Mental state Examination<=27
6.Beginner driver
<People with cognitive dysfunction>
Those who withdrew consent to provide information
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | Ayami |
| Middle name | |
| Last name | Yoshihara |
Organization
Nagoya City Rehabilitation Agency
Division name
Division of Occupational Therapy
Zip code
467-8622
Address
1-2 Mikanyama, Yatomi-cho, Mizuho-ku, Nagoya, Japan
TEL
052-835-3811
ot-dep@nagoya-rehab.or.jp
Public contact
Name of contact person
| 1st name | Ayami |
| Middle name | |
| Last name | Yoshihara |
Organization
Nagoya City Rehabilitation Agency
Division name
Division of Occupational Therapy
Zip code
467-8622
Address
1-2 Mikanyama, Yatomi-cho, Mizuho-ku, Nagoya, Japan
TEL
052-835-3811
Homepage URL
ot-dep@nagoya-rehab.or.jp
Sponsor or person
Institute
Nagoya City Rehabilitation Agency
Institute
Department
Personal name
Funding Source
Organization
Nagoya City Rehabilitation Agency
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya City Rehabilitation Agency
Address
1-2 Mikanyama, Yatomi-cho, Mizuho-ku, Nagoya, Japan
Tel
052-835-3811
soumubu@nagoya-rehab.or.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
名古屋市総合リハビリテーション事業団(愛知県)
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 11 | Month | 24 | Day |
Related information
URL releasing protocol
none
Publication of results
Published
Result
URL related to results and publications
https://www.igaku-shoin.co.jp/journal/detail/41289#tab2
Number of participants that the trial has enrolled
49
Results
Although the brain-injured drivers used a compensatory strategy of reducing speed, the driving behavior of the brain-injured drivers was characterized by frequent lane changes and emergency braking in situations involving other vehicles, which tended to result in unsafe vehicle behavior. It is necessary to comprehensively evaluate the driving behavior of brain-injured patients, including their driving behavior in a traffic environment that requires coordination with other vehicles.
Results date posted
| 2025 | Year | 02 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Brain-injured 26 persons, average age 45.3 years, 23 males, 3 females
23 normal subjects, average age 41.5 years, 16 males and 7 females
Participant flow
Interventions and analyses were conducted on 26 eligible brain-injured subjects and 23 general healthy subjects.
Adverse events
none
Outcome measures
Basic information on driving
Brain-injured subjects had an average of 3.2 violations, which was significantly higher than that of normal subjects (average 1.2 violations). The total weekly driving distance of the brain-injured subjects (mean: 268.3 km +- 504.9 km) was significantly longer than that of normal subjects (mean: 30.1 km +- 27.5 km). Brain-injured subjects had significantly lower MMSE total scores and significantly longer TMT-B times than normal subjects.
Average running speed Average driving speed
The mean driving speed of the brain-injured subjects (mean: 31.7 +- 1.6 km/h, median: 31.9 km/h) was significantly slower than that of the normal subjects (mean: 32.8 +- 1.9 km/h, median: 33.8 km/h) during the actual driving evaluation (p=0.035, r=0.30).
Occurrence of attentional behavior
A total of 19 cases (10 subjects) of attention behavior occurred in the brain-injured subjects. The behaviors were abrupt braking (9 cases, 6 subjects), right/left turn (5 cases, 3 subjects), curve operation (4 cases, 4 subjects), and driving habit/axel (1 case, 1 subject). Twenty-six cases (14 subjects) of cautionary behavior were observed among the normal subjects. The behaviors were abrupt braking (11 cases, 10 subjects), right/left turn (11 cases, 5 subjects), and curve operation (4 cases, 3 subjects).
Situations in which cautionary behavior occurred Situations in which cautionary behavior occurred
The videos of scenes in which attention behaviors occurred were qualitatively analyzed, and were classified into three types of scenes: (1) scenes in which the subject's own vehicle alone was involved in starting and speeding, (2) scenes involving other vehicles such as changing lanes, and (3) scenes related to responding to traffic signals. Brain-injured subjects were involved in 10 cases (52.6%) involving their own vehicle alone, 6 cases (31.6%) involving other vehicles, and 3 cases (15.8%) involving traffic signals, while healthy subjects were involved in 20 cases (76.9%), 1 case (3.8%), and 5 cases (19.2%), respectively. While most of the alert behaviors of the healthy subjects were caused by overspeeding of their own vehicle alone, those with brain injuries had significantly higher rates of alert behaviors in situations involving other vehicles, such as lane changes (p = 0.039, r = 0.36).
The results of this study were as follows. Driving Diagnostic Score
There were no significant differences between brain-injured subjects and normal subjects in all items of the driving assessment and in the total score.
Driving Assessment Scale
In the DAS, brain-injured subjects scored significantly lower than normal subjects on the item "checking for other vehicles at the right time and in the right way" at intersections and at traffic signs. On the other hand, brain-injured subjects scored significantly higher than normal subjects in the items of "maintain speed" when changing course and "safely back up" when parking. There were no significant differences between the two groups in driving, driving attitude, judgment, and total score.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 11 | Month | 16 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 16 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 16 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 11 | Month | 24 | Day |
Last modified on
| 2025 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048332
