UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042659 |
|---|---|
| Receipt number | R000048673 |
| Scientific Title | Validation of a Low Back Load Detection System at work Using Clothing-Based Wearable Sensor |
| Date of disclosure of the study information | 2020/12/07 |
| Last modified on | 2022/06/08 20:57:33 |
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Basic information
Public title
Validation of a System for Detecting Low Back Load Using Clothing-Based Sensors
Acronym
Validation of a System for Detecting Low back Load
Scientific Title
Validation of a Low Back Load Detection System at work Using Clothing-Based Wearable Sensor
Scientific Title:Acronym
Validation of a Low Back Load Detection System at work
Region
| Japan |
Condition
Condition
Healthy Controls
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to validate a novel system for assessing the load on the lumbar region at work using a wearable sensor.
Basic objectives2
Others
Basic objectives -Others
Validity
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
postural load
Key secondary outcomes
modified Borg scale, NRS(Numerical Rating Scale), Electromyography of Trunk and leg muscles, Back extensor strength, Spinal posture, Pulse frequence monitor
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Young Healthy Controls
Key exclusion criteria
The subjects
(1) have history of lumbar spine disease,
(2) are presenting with low back pain at rest and during exercise,
(3) have a history of severe osteoarticular disease and injuries to the upper and lower extremities.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Shin-Ichi |
| Middle name | |
| Last name | Izumi |
Organization
Tohoku University
Division name
Graduate School of Biomedical Engineering
Zip code
980-8574
Address
2-1, Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-7677
izumis@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Sekiguchi |
Organization
Tohoku University Hospital
Division name
Department of Rehabilitation
Zip code
980-8574
Address
1-1, Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-7677
Homepage URL
yusuke.sekiguchi.b2@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Hitachi, Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional review board in Tohoku University School of Medicine
Address
2-1, Seiryo-machi, Aoba-ku, Sendai
Tel
022-717-800
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
| 2020 | Year | 12 | Month | 07 | 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
13
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 12 | Month | 04 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 29 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 11 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The subject wears an electromyograph on the erector spinae muscle, heart rate monitor, and electrocardiogram monitor and also wears a clothing-type wearable sensor. Postural load is quantified from the kinematic data acquired by the wearable sensors using a proprietary system developed by Hitachi, Ltd. Three tasks are performed for 10 minutes. The subjects perform the following tasks: lightly flexed torso, upright torso, and elevating the shoulders. There are 10 minutes of adequate rest between each task.The measurements in 19 young healthy subjects have been completed. We are currently analyzing the data.
Management information
Registered date
| 2020 | Year | 12 | Month | 05 | Day |
Last modified on
| 2022 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048673
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
