UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038071 |
|---|---|
| Receipt number | R000043389 |
| Scientific Title | Clarification of the mechanism for relieving backpack burden caused by convoluted shoulder strap -cross-over study- |
| Date of disclosure of the study information | 2019/09/21 |
| Last modified on | 2020/08/31 12:33:30 |
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Basic information
Public title
Clarification of the mechanism for relieving backpack burden caused by convoluted shoulder strap -cross-over study-
Acronym
Newton bag study
Scientific Title
Clarification of the mechanism for relieving backpack burden caused by convoluted shoulder strap -cross-over study-
Scientific Title:Acronym
Newton bag study
Region
| Japan |
Condition
Condition
Porter Classic Co., Ltd. developed Newton bag, consisting egg shaped convoluted shoulder strap designed to decentralize pressure on shoulders. Unlike regular shape shoulder strap, the convoluted tip of Newton bag strap allows dispersion of pressure of luggage weight. However, the underlying mechanism remains to be clarified. We aim to determine the mechanism of how backpack burden is relieved by the convoluted shoulder strap.
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
efficacy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of posture in walking using motion capture
Key secondary outcomes
Evaluation by electromyogram
Measure of energy consumption volume
Measure of energy consumption volume
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Evaluation of posture in walking by using motion capture
Interventions/Control_2
Evaluation by electromyogram
Measure in energy consumption volume
Survey by questionnaire
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
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1 Healthy adults aged 20-40 years
2 Those who have received sufficient explanation for participation in this study and have provided written consent
Key exclusion criteria
1 Those who have a running disorder and/or internal medicine disease
2 Those who did not provide written consent
3 Those who were considered inappropriate for study participation by the research director
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Nishizaki |
Organization
Juntendo University
Division name
Medical Technology Innovation Center
Zip code
1138421
Address
2-1-1,Hongo, Bunkyo-ku, Tokyo 113-8421, Japan
TEL
0338133111
ynishiza@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Yuji |
| Middle name | |
| Last name | Nishizaki |
Organization
Juntendo University
Division name
Medical Technology Innovation Center
Zip code
1138421
Address
2-1-1,Hongo, Bunkyo-ku, Tokyo 113-8421, Japan
TEL
0338133111
Homepage URL
ynishiza@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Medical Technology Innovation Center
Institute
Department
Personal name
Funding Source
Organization
Porter Classic 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
Juntendo Clinical Research and Trial Center
Address
3-1-3,Hongo, Bunkyo-ku, Tokyo 113-8421, Japan
Tel
0338133111
kenkyu5858@juntendo.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
| 2019 | Year | 09 | Month | 21 | 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
10
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
Completed
Date of protocol fixation
| 2019 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2020 | 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
| 2019 | Year | 09 | Month | 21 | Day |
Last modified on
| 2020 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043389
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
