UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The development of a support system for teaching care workers by the measurements of posture and electromyogram of lower-back activities: open-label, non-randomaized, single group assignment, usability testing
Title of the study (Brief title)	Usability testing of a support system for teaching care workers by the measurements of posture and electromyogram of lower-back activities
Region	Japan

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

Objectives
Narrative objectives1	Usability testing of a support system for teaching care workers by the measurements of posture and electromyogram of lower-back activities
Basic objectives2	Others
Basic objectives -Others	The availability of a support system for teaching care workers by the measurements of posture and electromyogram of lower-back activities
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Counting the time and number of action and problems while using this support system for teaching care workers by the measurements of posture and electromyogram of lower-back activities by interviewing and video recording
Key secondary outcomes	Verify the workload by EMG integral value

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Device,equipment
Interventions/Control_1	recording EMG by a testing electromyograph within 2 hours
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 adult university student and authorized teacher in welfare course
Key exclusion criteria	Musculoskeletal disorder exercise hard in the day before the test so suffering from exhaustion fatigue
Target sample size	18

Research contact person
Name of lead principal investigator	TSUYOSHI YI YOTO
Organization	Industrial Research Institute of Shizuoka Prefecture
Division name	Universal Design Section
Address	2078 Makigaya Aoi-Ward Shizuoka-City Shizuoka-Pref. Japan
TEL	054-278-3024
Email	tsuyoshi1_ii@iri.pref.shizuoka.jp

Public contact
Name of contact person	TSUYOSHI YI YOTO
Organization	Industrial Research Institute of Shizuoka Prefecture
Division name	Universal Design Section
Address	2078 Makigaya Aoi-Ward Shizuoka-City Shizuoka-Pref. Japan
TEL	054-278-3024
Homepage URL
Email	s-ud@iri.pref.shizuoka.jp

Sponsor
Institute	Industrial Research Institute of Shizuoka Prefecture
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)

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	静岡福祉大学

Other administrative information
Date of disclosure of the study information	2018 Year 03 Month 19 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 03 Month 19 Day
Anticipated trial start date	2018 Year 03 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 03 Month 15 Day
Last modified on	2018 Year 03 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035979