UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020828 |
|---|---|
| Receipt number | 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 08:58:32 |
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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
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
s-ud@iri.pref.shizuoka.jp
Sponsor or person
Institute
Industrial Research Institute of Shizuoka Prefecture
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024045
