UMIN-CTR Clinical Trial

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