UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043207 |
|---|---|
| Receipt number | R000049311 |
| Scientific Title | Exercise-physiological characteristics of stepping operation due to sudden braking of automobile pedals |
| Date of disclosure of the study information | 2021/02/01 |
| Last modified on | 2021/08/03 09:26:26 |
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Basic information
Public title
Exercise-physiological characteristics of stepping operation due to sudden braking of automobile pedals in the elderly
Acronym
Sudden braking of car pedals in the elderly
Scientific Title
Exercise-physiological characteristics of stepping operation due to sudden braking of automobile pedals
Scientific Title:Acronym
Sudden braking of car pedals in the elderly
Region
| Japan |
Condition
Condition
Healthy person
Classification by specialty
| Neurology | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the exercise-physiological characteristics of the stepping operation associated with sudden braking of automobile pedals in the elderly
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Electromyography and kinematics data
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
| 21 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(i)Those who drive a car on a regular basis, (ii) ability to walk independently.
Key exclusion criteria
(i) Mini-Mental State Examination score of <24 points, (ii) no history of neurological disease, (iii) history of lower limb joint surgery, and (iv)treatment received for cardiovascular disease.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kazuki |
| Middle name | |
| Last name | Fujita |
Organization
Fukui Health Science University
Division name
Faculty of Health Science, Department of Rehabilitation
Zip code
910-3190
Address
55-13-1 Egami Fukui-city
TEL
+81776592201
k.fujita@fukui-hsu.ac.jp
Public contact
Name of contact person
| 1st name | Kazuki |
| Middle name | |
| Last name | Fujita |
Organization
Fukui Health Science University
Division name
Faculty of Health Science, Department of Rehabilitation
Zip code
910-3190
Address
55-13-1 Egami Fukui-city
TEL
+81776592201
Homepage URL
k.fujita@fukui-hsu.ac.jp
Sponsor or person
Institute
Fukui Health Science University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics committee of Nittazuka Medical Welfare Center
Address
58-16-1 Egami, Fukui-city
Tel
0776591300
fgh-hisyo@mopera.net
Secondary IDs
Secondary IDs
YES
Study ID_1
2 0 K 2 0 2 5 3
Org. issuing International ID_1
Japan Society for the Promotion of Science
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
https://www.mdpi.com/2227-9032/9/7/852/htm
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
| 2020 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 17 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The subject was instructed to visually check the real-time data of the accelerator tilt displayed on the monitor while holding the steering wheel, and to keep the accelerator depressed about 5 degrees. Next, the evaluator randomly turned on the three-color LEDs at intervals of 20 to 30 seconds. The subject switched to the brake as soon as possible when he saw the red light. The subject was free to decide the position and movement of the foot. The measurement was carried out for a total of 3 sets, with 1 set for 5 consecutive minutes.
Management information
Registered date
| 2021 | Year | 02 | Month | 01 | Day |
Last modified on
| 2021 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049311
