UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050771 |
|---|---|
| Receipt number | R000057854 |
| Scientific Title | Brain lesion location in acute stroke patients and and driving ability in a driving simulator and and the ability to resume driving in a driving simulator and the ability to resume driving a car. |
| Date of disclosure of the study information | 2023/04/10 |
| Last modified on | 2023/04/10 12:46:44 |
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Basic information
Public title
Relationship between cerebral infarction patients and driving
Acronym
Relationship between cerebral infarction patients and driving
Scientific Title
Brain lesion location in acute stroke patients and and driving ability in a driving simulator and and the ability to resume driving in a driving simulator and the ability to resume driving a car.
Scientific Title:Acronym
Brain lesion location in acute stroke patients and and driving ability in a driving simulator and and the ability to resume driving in a driving simulator and the ability to resume driving a car.
Region
| Japan |
Condition
Condition
cerebral infarction
Classification by specialty
| Neurology | Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1) To clarify the relationship between the location of the cerebral lesion and the driving ability assessment items using a driving simulator and the possibility of resuming driving in patients with cerebral infarction who were discharged directly home from an acute care hospital who resumed driving within 6 months after the onset of cerebral infarction.
2) If the relationship between the location of the cerebral infarction lesion and the driving ability assessment items using a driving simulator and the possibility of resumption of driving are clarified, valuable information for predicting resumption of driving in the early stage after cerebral infarction will be obtained.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Driving ability by driving simulator evaluation
Key secondary outcomes
Whether or not to resume operation
Base
Study type
Observational
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Those who had a cerebral infarction (lacunar infarction, atherothrombotic cerebral infarction, cardiogenic cerebral embolism) and were hospitalized.
(2) Those who were driving before hospitalization and wished to resume driving.
(3) Those who were instructed by a physician to be evaluated for driving.
(4) Those who scored 5 or more points in walking and toileting on the Functional Independence Measure (hereinafter referred to as "FIM") and were independent from monitoring in the hospital room (because it is desirable that acquisition of personal ADLs has been achieved and the goal has been shifted to acquisition of IADLs).
(5) Those who were discharged directly home after the assessment was performed during their acute care hospitalization.
Key exclusion criteria
(1) Those who have certain diseases (dementia, epilepsy, etc.) that may result in suspension or denial of driver's license, and who have already been judged by a physician to be unfit to drive.
(2) Those who have been transferred to a convalescent hospital or a convalescent home.
(3) Those who had difficulty in completing the DS evaluation due to screen sickness or inability to understand the sub-test items of the DS evaluation.
(4) Patients who had recurrence of disease during the follow-up period and whose outcome was difficult to follow up.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Obuchi |
| Middle name | |
| Last name | Kohei |
Organization
Nagano Matsudai General Hospital
Division name
Rehabilitation Department
Zip code
3811231
Address
183 Matsushiro, Matsushiro-cho, Nagano City, Nagano Prefecture
TEL
0262782031
kindai0707@gmail.com
Public contact
Name of contact person
| 1st name | Obuchi |
| Middle name | |
| Last name | Kohei |
Organization
Nagano Matsudai General Hospital
Division name
Rehabilitation Department
Zip code
381123
Address
183 Matsushiro, Matsushiro-cho, Nagano City, Nagano Prefecture
TEL
0262782031
Homepage URL
kindai0707@gmail.com
Sponsor or person
Institute
Nagano Matsudai General Hospital
Institute
Department
Personal name
Funding Source
Organization
Without
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagano Matsudai General Hospital
Address
183 Matsushiro, Matsushiro-cho, Nagano City, Nagano Prefecture
Tel
0262782031
kindai0707@gmail.com
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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 04 | Month | 10 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 04 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 04 | Month | 18 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Therefore, in this study, we will investigate the relationship between the location of cerebral infarction lesion and driving ability and resumption of driving in patients with acute stroke. By clarifying these relationships, we believe that this study will be useful in predicting the driving ability and resumption of driving of patients with acute cerebral infarction, as well as in considering support methods.
Management information
Registered date
| 2023 | Year | 04 | Month | 05 | Day |
Last modified on
| 2023 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057854
