UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034726 |
|---|---|
| Receipt number | R000039594 |
| Scientific Title | The investigation of association between driving ability and cognitive function and attentiveness for patients with Parkinson's disease. |
| Date of disclosure of the study information | 2018/11/01 |
| Last modified on | 2025/05/06 09:37:48 |
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Basic information
Public title
The investigation of association between driving ability and cognitive function and attentiveness for patients with Parkinson's disease.
Acronym
The investigation of association between driving ability and cognitive function and attentiveness of PD patients.
Scientific Title
The investigation of association between driving ability and cognitive function and attentiveness for patients with Parkinson's disease.
Scientific Title:Acronym
The investigation of association between driving ability and cognitive function and attentiveness of PD patients.
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
At present, there is no indicator for advising Parkinson's disease patient to stop driving a car. In this study, we evaluated driving skills using driving simulators for patients with parkinson's disease who had a history of driving and evaluated the cognitive function, performance function, attention function. We will examine which inspection items are related to decline in driving skills.
Basic objectives2
Others
Basic objectives -Others
Based on the results, we find indicators for advice on driving from the medical staff side.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
We analyzed the relationship between the score of driving simulator and cognitive function, performance function, attention function.
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
Patients with Parkinson's disease
Key exclusion criteria
Patients with reduced vision
Patients who can not sit up
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Rina |
| Middle name | |
| Last name | Ando |
Organization
Ehime University Graduate School of Medicine
Division name
Neurology and clinical pharmacology
Zip code
791-0295
Address
Shizukawa454, Toon city, Ehime,Japan 791-0295
TEL
089-960-5095
ando.rina.cn@ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | Rina |
| Middle name | |
| Last name | Ando |
Organization
Ehime University Graduate school of medicine
Division name
Neurology and clinical pharmacology
Zip code
791-0295
Address
Shizukawa454, Toon city, Ehime,Japan 791-0295
TEL
089-960-5095
Homepage URL
ando.rina.cn@ehime-u.ac.jp
Sponsor or person
Institute
Ehime University Graduate school of medicine
Institute
Department
Personal name
Funding Source
Organization
No funding source
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
Institutional Review Board ,Ehime University Hospital
Address
shitsukawa454,Toon city, Ehime,Japan
Tel
089-960-5172
rinri@m.ehime-u.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 | 11 | 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
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
| 2018 | Year | 09 | Month | 03 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 25 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We analyze the relationship between driving skills, cognitive function, performance function, attention and movement symptoms of Parkinson's disease patients.
Management information
Registered date
| 2018 | Year | 10 | Month | 31 | Day |
Last modified on
| 2025 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039594
