UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035563 |
|---|---|
| Receipt number | R000040520 |
| Scientific Title | Development of smart shoes for prevention of fall on Winter road |
| Date of disclosure of the study information | 2019/10/01 |
| Last modified on | 2021/01/21 10:28:25 |
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Basic information
Public title
Development of smart shoes for prevention of fall on Winter road
Acronym
Development of Smart shoes for the purpose of fall prevention
Scientific Title
Development of smart shoes for prevention of fall on Winter road
Scientific Title:Acronym
Development of Smart shoes for the purpose of fall prevention
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to develop smart shoes with anti-slip functions that automatically protrude spikes, etc. on a road surface discrimination function such as a slippery road surface, and a high risk of falls, which is the ultimate target for prevention of falling accidents of pedestrians in a frozen road in snowy cold regions.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Gait analysis of one walking cycle on a frozen road surface
Key secondary outcomes
gait speed, acceleration, temperature
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Smart Shoes/Regular shoes
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
A healthy person without a history
Key exclusion criteria
Past history and persons with disabilities
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | keisuke |
Organization
Hokkaido University of science
Division name
Faculty of Health Sciences
Zip code
006-8585
Address
4-1, 15tyo-me, 7jyo, maeda, teine-ku, Sapporo city
TEL
011-688-2240
kon@hus.ac.jp
Public contact
Name of contact person
| 1st name | kon |
| Middle name | |
| Last name | Keisuke |
Organization
Hokkaido University of science
Division name
Faculty of Health Sciences
Zip code
006-8585
Address
4-1, 15tyo-me, 7jyo, maeda, teine-ku, Sapporo city
TEL
011-688-2240
Homepage URL
kon@hus.ac.jp
Sponsor or person
Institute
Hokkaido University of science
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University of science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokkaido University of science
Address
7-15-4-1 Maeda, Teine
Tel
011-688-2240
kon@hus.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
北海道科学大学（北海道）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 10 | Month | 01 | 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
3
Results
It took 18 seconds for the pin to go all the way out of the icy road surface, but the mechanism worked without any problems.
Results date posted
| 2020 | Year | 07 | Month | 21 | Day |
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 10 | Month | 01 | 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 | 01 | Month | 16 | Day |
Last modified on
| 2021 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040520
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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