UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052870 |
|---|---|
| Receipt number | R000060334 |
| Scientific Title | Relationship between in-hospital assessment of driving in acute stroke survivors and their driving behaviour one year after stroke onset |
| Date of disclosure of the study information | 2023/11/23 |
| Last modified on | 2025/05/25 03:27:34 |
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Basic information
Public title
Relationship between in-hospital assessment of driving in acute stroke survivors and their driving behaviour one year after stroke onset
Acronym
Relationship between in-hospital assessment of driving in acute stroke survivors and their driving behaviour one year after stroke onset
Scientific Title
Relationship between in-hospital assessment of driving in acute stroke survivors and their driving behaviour one year after stroke onset
Scientific Title:Acronym
Relationship between in-hospital assessment of driving in acute stroke survivors and their driving behaviour one year after stroke onset
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the association between clinical factors such as lesion location during hospitalisation, stroke severity, cognitive impairment, visual and spatial impairment, other neuropsychological tests and driving simulators, and driving behaviour, accidents and other outcomes one year after stroke.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Whether driving has resumed at 1 year after stroke onset, changes in driving conditions such as frequency and duration of driving compared to before stroke onset, accidents after resumption of driving (police action, self-inflicted injuries, near-misses).
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(i) Those who have suffered a stroke (cerebral infarction/ischemic ischaemic attack, cerebral haemorrhage, subarachnoid haemorrhage) and have been hospitalised.
(ii) Those who were driving before hospitalisation and wished to resume driving
(iii) Those who were instructed by a physician to be evaluated for driving.
(iv) Persons who were assessed during admission to an acute care hospital and discharged directly home.
Key exclusion criteria
(i) Those who have certain illnesses, etc. (dementia, epilepsy, etc.) that will result in the suspension or refusal of their driving licence during the follow-up period, and who have been judged by a doctor to be unfit to drive.
(2) Those who were transferred to convalescent or convalescent hospitals.
(iii) Those who had recurrence or death during the follow-up period and whose outcome could not be traced.
Target sample size
100
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, Nagano.
TEL
0262782031
kindai0707@gmail.com
Public contact
Name of contact person
| 1st name | Nagaoka |
| Middle name | |
| Last name | Erika |
Organization
Nagano Matsudai General Hospital
Division name
Education and Training Section
Zip code
3811231
Address
183 Matsushiro, Matsushiro-cho, Nagano, Nagano.
TEL
0262782031
Homepage URL
kindai0707@gmail.com
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
Shinshu University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagano Matsushiro General Hospital
Address
183 Matsushiro, Matsushiro-cho, Nagano, Nagano.
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 | 11 | Month | 23 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Information on subjects discharged between April 2022 and April 2024 will be collected retrospectively from the medical records of Nagano Matsudai General Hospital, as described in '6. Observation and examination items and schedule' below. Questionnaires will be mailed sequentially starting with subjects who have been discharged from the hospital one year after the onset of illness. This study will be conducted as a multicentre collaborative study between Nagano Matsudai General Hospital and Shinshu University School of Medicine.
Management information
Registered date
| 2023 | Year | 11 | Month | 22 | Day |
Last modified on
| 2025 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060334
