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, work load trial
Title of the study (Brief title)	The development of a support system for teaching care workers by the measurements of posture and electromyogram of lower-back activities
Region	Japan

Condition
Condition	healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	a comparative verification of whether the measured values from a commercially available electromyograph and a trial one are the same during lower-back activities of care operation
Basic objectives2	Others
Basic objectives -Others	1) correlation between the values measured by a commercially available electromyograph and a trial one 2) correlation between the values measured by electromyograph and questionnaire
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	1) iEMG of a single cycle of lifting and lowering a designated weight 2) amplitude of EMG in a single cycle of lifting and lowering a designated weight 3)questionnaire regarding subjective feeling of single cycle of lifting and lowering a designated weight 4) correlation of 1),2)between the values measured by a commercially available electromyograph and a trial one 5) correlation between of 3)and 1)or 2)
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	Uncontrolled
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	low-back activities with 3 designated weights(0,4,8kg) at 3 different back angles(45,90deg), 2 different distance to catch the weight and 2 step speeds (50,60bpm)when lifting and lowering in 6 steps and repeat 3 times.
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
Key exclusion criteria	musculoskeletal disorder exercise hard in the day before test so suffering from exhaustion fatigue
Target sample size	10

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	静岡県工業技術研究所 Industrial Research Institute of Shizuoka Prefecture

Other administrative information
Date of disclosure of the study information	2016 Year 02 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 02 Month 01 Day
Anticipated trial start date	2016 Year 02 Month 01 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	Partially published
URL releasing results
Results	The integrated EMG values of the erector spinae muscle obtained on each subject showed a strong positive correlation between the two systems.
Other related information	This results was presented in poster section in June 1 at ACED2017.

Management information
Registered date	2016 Year 02 Month 01 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=R000024045