UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049661 |
|---|---|
| Receipt number | R000056565 |
| Scientific Title | Varidation of preferable seated posture-maitaining effect of the posture-monitoring device |
| Date of disclosure of the study information | 2022/12/18 |
| Last modified on | 2022/12/01 19:05:06 |
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Basic information
Public title
Varidation of preferable seated posture-maitaining effect of the posture-monitoring device
Acronym
Varidation of the posture-monitoring device
Scientific Title
Varidation of preferable seated posture-maitaining effect of the posture-monitoring device
Scientific Title:Acronym
Varidation of the posture-monitoring device
Region
| Japan |
Condition
Condition
stiff neck, neck pain
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1. To elucidate changes in cervical spine alignment before and after use of information terminals.
2. Observe changes in cervical spine alignment with and without the use of the posture correction mode of the device (spine monitor) (children and students).
3. Observe changes in cervical spine alignment with and without the use of the posture correction mode in the device (children and students).
4. To examine the qualitative and quantitative correlates of neck pain with the use of the dorsometer using a patient-oriented questionnaire (adults).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Verification 1. Verification of the effect of using the "Spine Gauge" (adult)
Visual Analogue Scale, Neck Disability Index, and device-derived visual distance and distance to screen during work tasks over time
Verification 2: Verification of Posture Correction Mode
Longitudinal changes in visual distance and distance to the screen obtained from the device during a specific task.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Validation 1. wearing Monday-Friday work hours
Group not informed of daily postural information (control group)
Interventions/Control_2
Validation 1. wearing Monday-Friday work hours
Group informed of daily postural information (control group)
Interventions/Control_3
Verification 2. worn during the specified work time of about 10 minutes
Groups with no change in the work screen
Interventions/Control_4
Verification 2. worn during the specified work time of about 10 minutes
Group with darkened work screen due to poor posture
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 6 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Age: 6 years old or older (at the time of registration)
Key exclusion criteria
Exclude the following persons who are considered to have an effect on cervical spine motion or muscle activity of the perioccipital muscles of the neck.
(1) Patients with a history of trauma to the neck and shoulder joint within 6 months (including traffic accidents)
(2)Those who are under outpatient treatment for spinal disorders (including neck pain and back pain)
(3)BMI (body mass index) 30 or higher
(4)Currently suffering from a spinal disease and undergoing outpatient treatment
(5)Those who cannot tolerate light work (typing, calculation problems for several minutes in a row, etc.) on an information terminal.
(6) Those who have obvious spinal deformities, whether untreated or treated.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Ko |
| Middle name | |
| Last name | Hashimoto |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
0227177245
khashimoto@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Ko |
| Middle name | |
| Last name | Hashimoto |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
0227177245
Homepage URL
khashimoto@med.tohoku.ac.jp
Sponsor or person
Institute
Department of Orthopaedic Surgery, Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Orthopaedic Surgery, Tohoku University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee, Tohoku University Graduate School of Medicine
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
Tel
022-728-4105
rinri-esct@proj.med.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 | 12 | Month | 18 | 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 | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 12 | Month | 18 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 12 | Month | 01 | Day |
Last modified on
| 2022 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056565
| 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 |
