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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040265
Receipt No. 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

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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
Email 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
Email seki@med.u-toyama.ac.jp

Sponsor
Institute Other
Hashimoto baggage Co., Ltd.
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045923

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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