UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048763 |
|---|---|
| Receipt number | R000055550 |
| Scientific Title | Forecasting daily physical discomfort through unobtrusive sensor signal analyses |
| Date of disclosure of the study information | 2022/09/15 |
| Last modified on | 2022/08/26 20:00:02 |
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Basic information
Public title
Forecasting daily physical discomfort using unobtrusive sensors
Acronym
Discomfort forecasting
Scientific Title
Forecasting daily physical discomfort through unobtrusive sensor signal analyses
Scientific Title:Acronym
Forecasting daily physical discomfort through unobtrusive sensor signal analyses
Region
| Japan |
Condition
Condition
Healthy
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to examine continuous sensing of posture and heart rate enables prediction of discomfort during desk work such as low back pain, headache, and neck pain
Basic objectives2
Others
Basic objectives -Others
In order to investigate whether continuous sensing and AI based analyses of posture and bio-signals such as heart rate would enable us to predict worsening of subjective discomfort such as low back pain, neck pain, headache or eye strain.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Worsening of neck pain/headache/low back pain/eye strain
Key secondary outcomes
Subjective efficiency of work
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Healthy person engaged in desk works more than 3 days/week for more than 1 year.
2. Owns smartphone and agrees to access to google forms 4 times/day for discomfort level report.
3. Agrees to install a web-camera that records the head movement during work.
Key exclusion criteria
1. Under clinical management for headache, neck pain, or low back pain in clinics.
2. Under clinical management of glaucoma or cataract.
3. Pregnant or possible pregnancy
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Ryoichi |
| Middle name | |
| Last name | Nagatomi |
Organization
Tohoku University
Division name
Graduate School of Biomedical Engineering
Zip code
980-8575
Address
Seiryo-cho 2-1, Aoba-ku, Sendai, Japan
TEL
022-717-8586
nagatomi@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Ryoichi |
| Middle name | |
| Last name | Nagatomi |
Organization
Tohoku University
Division name
Graduate School of Biomedical Engineering
Zip code
980-8575
Address
Seiryo-cho 2-1, Aoba-ku, Sendai, Japan
TEL
022-717-8586
Homepage URL
nagatomi@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Japan Science & Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
Seiryo 2-1, Aoba-ku, Sendai, Japan
Tel
022-717-8007
med-kenkyo@grp.tohoku.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
| 2022 | Year | 09 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 08 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The participants are expected to rate their levels of discomfort using a Lickert scale from 0 to 10 4 times daily.
Management information
Registered date
| 2022 | Year | 08 | Month | 26 | Day |
Last modified on
| 2022 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055550
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
