UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040143
Receipt number R000045711
Scientific Title Development of an assist suit suitable for dairy work
Date of disclosure of the study information 2020/04/13
Last modified on 2020/04/13 15:45:56

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Basic information

Public title

Development of an assist suit suitable for dairy work

Acronym

Development of an assist suit suitable for dairy work

Scientific Title

Development of an assist suit suitable for dairy work

Scientific Title:Acronym

Development of an assist suit suitable for dairy work

Region

Japan


Condition

Condition

Healthy adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To consider whether the designed assist suit has the effect of reducing fatigue

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Required time, State of work, Feeling fatigue,subjective evaluation

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

Whether or not to wear an assist suit within 1 hour

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


Not applicable

Gender

Male and Female

Key inclusion criteria

Healthy person

Key exclusion criteria

Musculoskeletal disorder, exercised vigorously the day before,drank after 21:00 on the day before the test,stayed up all night

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Kumi
Middle name
Last name OGA

Organization

Industrial Research Institute of Shizuoka Prefecture

Division name

Universal Design Section

Zip code

421-1298

Address

2078 Makigaya Aoi-Ward Shizuoka-City Shizuoka-Pref. Japan

TEL

054-278-3024

Email

kumi1_oga@pref.shizuoka.lg.jp


Public contact

Name of contact person

1st name Kumi
Middle name
Last name OGA

Organization

Industrial Research Institute of Shizuoka Prefecture

Division name

Universal Design Section

Zip code

421-1298

Address

2078 Makigaya Aoi-Ward Shizuoka-City Shizuoka-Pref. Japan

TEL

054-278-3024

Homepage URL


Email

kumi1_oga@pref.shizuoka.lg.jp


Sponsor or person

Institute

Industrial Research Institute of Shizuoka Prefecture

Institute

Department

Personal name



Funding Source

Organization

Industrial Research Institute of Shizuoka Prefecture

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Industrial Research Institute of Shizuoka Prefecture

Address

2078 Makigaya Aoi-Ward Shizuoka-City Shizuoka-Pref. Japan

Tel

054-278-3024

Email

kumi1_oga@pref.shizuoka.lg.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

2020 Year 04 Month 13 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

10

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

Completed

Date of protocol fixation

2020 Year 02 Month 01 Day

Date of IRB

2019 Year 10 Month 04 Day

Anticipated trial start date

2020 Year 02 Month 03 Day

Last follow-up date

2020 Year 02 Month 26 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 04 Month 13 Day

Last modified on

2020 Year 04 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045711


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name