UMIN-CTR Clinical Trial

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
Email	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
Email	k.fujita@fukui-hsu.ac.jp

Sponsor
Institute	Fukui Health Science University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000049311