UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040265 |
|---|---|
| Receipt number | R000045923 |
| Scientific Title | Preliminary study to examine the influence of new school bag on posture of elementary school children |
| Date of disclosure of the study information | 2020/04/28 |
| Last modified on | 2020/04/28 15:55:57 |
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Basic information
Public title
Preliminary study to examine the influence of new school bag on posture of elementary school children
Acronym
A study to examine the influence on posture of a new school bag
Scientific Title
Preliminary study to examine the influence of new school bag on posture of elementary school children
Scientific Title:Acronym
A study to examine the influence on posture of a new school bag
Region
| Japan |
Condition
Condition
Scoliosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of improving the back muscle strength and abdominal muscle strength and posture of elementary school students who use the new school backpack compared to normal school backpacks.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Strength evaluation: abdominal muscles, back muscles, grip strength
Posture evaluation: Image evaluation of both auricles, cervical spine curvature, back curvature, lumbar curvature (side image)
Objective evaluation of posture (evaluated with a maximum of 5 points)
StreThe nape is stretched and the chin is closedtched s
Be proud
Both shoulders pulled behind
Strength in the lower abdomen (Umbuntanda)
pine
Relaxing with no tension in the muscles of the whole body
Be well balanced and stable
Passing through the knee joint and falling just in front of the ankle of the foot (no front-back inclination)
The spine has a gentle S-shaped curve
Left and right spinal column not evenly curved
The abdominal and back muscles that support
Evaluate 11 items on a scale of 5 the spine are strong
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Measure and evaluate muscular strength (grip strength, back strength, abdominal strength) and posture, and use a new or normal school bag to measure muscle strength and posture again after 1 month, 3 months, and 6 months.
Interventions/Control_2
Spinal alignment changes
Objective evaluation of posture
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
| 6 | years-old | <= |
Age-upper limit
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy children who can agree to Hashimoto's school bag design
Key exclusion criteria
Parents or children who do not agree with the purpose of this study
Those with spinal disorders
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Shoji |
| Middle name | |
| Last name | Seki |
Organization
Academic Research Department
Division name
Orthopedics / Motorology
Zip code
930-0194
Address
2630 Sugitani, Toyama
TEL
076-434-7353
seki@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Shoji |
| Middle name | |
| Last name | Seki |
Organization
Academic Research Department
Division name
Orthopedics / Motorology
Zip code
930-0194
Address
2630 Sugitani, Toyama
TEL
076-434-7353
Homepage URL
seki@med.u-toyama.ac.jp
Sponsor or person
Institute
Other
Hashimoto baggage Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Other
Hashimoto baggage Co., 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
General Incorporated Association National University Hospital Directors Meeting
Address
5th floor, Grand Forks V Hongo Building, 3-25-13 Hongo, Bunkyo-ku, Tokyo
Tel
03-5684-1601
inchokaigi-office@umin.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 | 04 | Month | 28 | 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
| 2020 | Year | 04 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 04 | Month | 30 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 04 | Month | 28 | Day |
Last modified on
| 2020 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045923
