UMIN-CTR Clinical Trial

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
Institute	Industrial Research Institute of Shizuoka Prefecture
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045711