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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020828
Receipt No. R000024045
Scientific Title 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
Date of disclosure of the study information 2016/02/01
Last modified on 2018/03/30

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Basic information
Public title 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
Acronym The development of a support system for teaching care workers by the measurements of posture and electromyogram of lower-back activities
Scientific Title 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
Scientific Title:Acronym 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
1st name
Middle name
Last name TSUYOSHI YI YOTO
Organization Industrial Research Institute of Shizuoka Prefecture
Division name Universal Design Section
Zip code
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
1st name
Middle name
Last name TSUYOSHI YI YOTO
Organization Industrial Research Institute of Shizuoka Prefecture
Division name Universal Design Section
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The integrated EMG values of the erector spinae muscle obtained on each subject showed a strong positive correlation between the two systems.
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
2016 Year 02 Month 01 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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