UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052941 |
|---|---|
| Receipt number | R000060407 |
| Scientific Title | Driving behavior characteristics of brain damaged people using a driving simulator |
| Date of disclosure of the study information | 2023/11/29 |
| Last modified on | 2023/11/29 12:07:14 |
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Basic information
Public title
Driving behavior characteristics of brain damaged people using a driving simulator
Acronym
Driving behavior characteristics of brain damaged people using a driving simulator
Scientific Title
Driving behavior characteristics of brain damaged people using a driving simulator
Scientific Title:Acronym
Driving behavior characteristics of brain damaged people using a driving simulator
Region
| Japan |
Condition
Condition
Brain injury
Classification by specialty
| Neurology | Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To bring out the driving behavior characteristics of brain damaged people using a driving simulator.
Basic objectives2
Others
Basic objectives -Others
Brake reaction time, standard deviation of brake reaction time, steering wheel operation error rate in driving simulator
Trial characteristics_1
Others
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Brake reaction time, standard deviation of brake reaction time, steering wheel operation error rate in driving simulator
Key secondary outcomes
Higher brain function test (MMSE, TMT) and useful field of view test (UFOV)
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
1. Brain injured person
(1)Target disease
Those who have been diagnosed with a brain injury (cerecral infarction, serebral hemorrhage, traumatic brain injury, subarachonoid hemorrhage) by a doctor and have undergone a driving aptitude evaluation at our center.
(2)Target age and gender
People aged 20 to under 65, regardless of gender
(3)Inpatient/ outpatient status
Those who are hospitalized at our center or who are visiting the outpatient clinic
(4)Driving status before onset of illness
Those who drove a car at least once a week before the onset of illness
(5)Possession of a driver's license
Must have a valid driver's license
2. Healthy control
(1)Target age and gender
Persons ages 20 to under 65, regardless of gender
(2)Driving status
Those who regularly drive a car more than once a week
(3)Accident/ violation history
Persons who have had no accidents or violations in the past year
(4)Agreement to participate in research
Subjects must be those who understand the content of this research and have provided written consent.
Key exclusion criteria
1. Brain injured person
(1)Those who have obvious motor paralysis in their body
(2)Those with a history of epilepsy
(3)People who have difficulty walking independently and are not independent in activities of daily living
2. Healthy person
(1)Those who have obvious motor paralysis in their body
(2)Those with a history of epilepsy
(3)People who have difficulty walking independently and are not independent in activities of daily living
(4)Those who have been diagnosed with brain injury (cerebral infarction, cerebral hemorrhage, traumatic brain injury)
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Hajime |
| Middle name | |
| Last name | Tanaka |
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 | Hajime |
| Middle name | |
| Last name | Tanaka |
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-u.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
| 2023 | Year | 11 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 08 | Month | 02 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 04 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
(Interventions for people with brain injury)
We collect the following information from electronic medical records. Basic information (age, gender, diagnosis name, brain imaging information, onset date), questionnaire results (driving purpose, years of driving license, driving frequency, accident/ violation history), cognitive function test results (MMSE, TMT, FAB, REY), results of driving behavior evaluation using a driving simulator.
(Interventions for healthy people)
The following items will be measured: Basic information and driving-related questionnaire survey (age, gender, purpose of driving, number of years since obtaining a driver's license, frequency of driving, number of accidents/ violations), cognitive function tests (MMSE, TMT, FAB, REY), driving behavior evaluation using a driving simulator.
Management information
Registered date
| 2023 | Year | 11 | Month | 29 | Day |
Last modified on
| 2023 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060407
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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