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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049311


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name