UMIN-CTR Clinical Trial

Basic information
Public title	Quantification analysis of human motion using wearable device.
Acronym	Quantification analysis of human motion using wearable device.
Scientific Title	Quantification analysis of human motion using wearable device.
Scientific Title:Acronym	Quantification analysis of human motion using wearable device.
Region	Japan

Condition
Condition	Healthy
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Quantify human motion using a physical phenomenon measuring sensor built in a wearable device on the human body surface.
Basic objectives2	Others
Basic objectives -Others	Availability and effectiveness of wearable devices for safe operation
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The potential of the sensor built in a wearable device and its change over time
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	Tracking the target on the monitor
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Healthy person who gained consent by the voluntary with understanding after having explanation
Key exclusion criteria	Healthy people judged inappropriate by the research director research sharing person
Target sample size	500

Research contact person
Name of lead principal investigator	1st name Makoto Middle name Last name Hibiya
Organization	Fujita Health University
Division name	School of Medical Sciences
Zip code	470-1192
Address	Kutsukake-cho, Toyoake, Aichi
TEL	0562-93-2654
Email	mhibiya@fujita-hu.ac.jp

Public contact
Name of contact person	1st name Makoto Middle name Last name Hibiya
Organization	Fujita Health University
Division name	School of Medical Sciences
Zip code	470-1192
Address	Kutsukake-cho, Toyoake, Aichi
TEL	0562-93-2654
Homepage URL
Email	mhibiya@fujita-hu.ac.jp

Sponsor
Institute	Fujita Health University
Institute
Department

Funding Source
Organization	Fujita Health University School of Medical Sciences
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Fujita Health University, School of Medical Sciences
Address	Kutsukake-cho, Toyoake, Aichi, Japan
Tel	0562-93-2654
Email	mhibiya@fujita-hu.ac.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	2018 Year 05 Month 02 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
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	2017 Year 11 Month 28 Day
Date of IRB	2017 Year 11 Month 10 Day
Anticipated trial start date	2017 Year 11 Month 29 Day
Last follow-up date	2022 Year 11 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 05 Month 02 Day
Last modified on	2022 Year 11 Month 07 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037016