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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000035563
Receipt No. 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

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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
Email 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
Email kon@hus.ac.jp

Sponsor
Institute Hokkaido University of science
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040520

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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