UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032547 |
|---|---|
| Receipt number | R000037117 |
| Scientific Title | Relationship between subjective driving skills in elderly drivers and pain during driving and fear of driving |
| Date of disclosure of the study information | 2018/06/01 |
| Last modified on | 2020/05/11 13:17:22 |
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Basic information
Public title
Relationship between subjective driving skills in elderly drivers and pain during driving and fear of driving
Acronym
Relationship between subjective driving skills and physical and mental functions of elderly drivers
Scientific Title
Relationship between subjective driving skills in elderly drivers and pain during driving and fear of driving
Scientific Title:Acronym
Relationship between subjective driving skills and physical and mental functions of elderly drivers
Region
| Japan |
Condition
Condition
Healthy elderly people
Classification by specialty
| Geriatrics | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this research is to conduct a survey on the relationship between self-evaluation on driving skills in elderly drivers and the existence of chronic pain site and anxiety about driving.
Basic objectives2
Others
Basic objectives -Others
Obtain data that contributes to screening evaluation of high risk drivers.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective driving skill score by questionnaire survey.
Key secondary outcomes
Anxiety about driving
Presence or absence of chronic pain during driving.
Past accident history.
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
| Other |
Interventions/Control_1
Questionnaire survey for healthy elderly.
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
| 65 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Elderly people who understand the research contents and are driving a car on a daily basis.
Key exclusion criteria
Person who has obvious cognitive decline or central nervous system disorder.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Katsuhiko |
| Middle name | |
| Last name | Takatori |
Organization
Kio University
Division name
Faculty of Health Science, Department of Physical Therapy
Zip code
6300137
Address
4-2-2 Umami-naka, Koryo, Kitakatsuragi-gun, Nara
TEL
0745541601
k.takatori@kio.ac.jp
Public contact
Name of contact person
| 1st name | Katsuhiko |
| Middle name | |
| Last name | Takatori |
Organization
Kio University
Division name
Faculty of Health Science, Department of Physical Therapy
Zip code
6350832
Address
4-2-2 Umami-naka, Koryo, Kitakatsuragi-gun, Nara
TEL
0745541601
Homepage URL
k.takatori@kio.ac.jp
Sponsor or person
Institute
Kio University
Institute
Department
Personal name
Funding Source
Organization
Kio University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kio University
Address
4-2-2 Umami-naka, Koryo, Kitakatsuragi-gun, Nara
Tel
0745541601
k.takatori@kio.ac.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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 06 | Month | 01 | 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
124
Results
Focusing on physical function, elderly people had a significantly higher proportion of the following questions than non-elderly people: "It is difficult for the neck to go backward when directly checking the back." "It's difficult to get in and out of the car because the body is less flexible." As for the importance of cars in daily life, more elderly people needed cars than non-elderly people.There was no difference in the fear of driving a car between the elderly and non-elderly.
Results date posted
| 2020 | Year | 05 | Month | 11 | Day |
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
Completed
Date of protocol fixation
| 2018 | Year | 05 | Month | 10 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 25 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 10 | Day |
Last modified on
| 2020 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037117
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
