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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000034652
Receipt No. R000039507
Scientific Title Combined evaluation of energizing alerts to encourage danger avoidance operation when blind persons move-2
Date of disclosure of the study information 2018/10/25
Last modified on 2019/04/26

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Basic information
Public title Combined evaluation of energizing alerts to encourage danger avoidance operation when blind persons move-2
Acronym Energizing alert test
Scientific Title Combined evaluation of energizing alerts to encourage danger avoidance operation when blind persons move-2
Scientific Title:Acronym Energizing alert test
Region
Japan

Condition
Condition Blind person
Classification by specialty
Ophthalmology Rehabilitation medicine Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In order to avoid the type of falling platform platform fall accident, based on the result of carrying out the experiment to introduce the newly developed electrification alert (warning) technology in FY 2017, further clarify the success rate .
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Success rate of the intervention condition (when the device is driven) against the control condition (the device does not operate)
Key secondary outcomes Movie being tried, heart rate (RR interval, HR), accelerometer value attached to the body, record of instruction contents, Likert scale between sense of fear before and after trial, time required for trial

Base
Study type Interventional

Study design
Basic design Factorial
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Process the signal of the sensor that detects the approach of the human body, replace it with the energizing signal, and inform the blind person of the danger.
The case walks 3 meters walking path three times.
Experiments are carried out one unit with this 3 steps of walking as one unit per day.
Each time seamlessly connects the sensor and wireless communication when the other person collides at an arbitrary timing to the input device and the output device.
Interventions/Control_2 Process the signal of the sensor that detects the approach of the human body, replace it with the energizing signal, do not let the blind person know the danger.
The case walks 3 meters walking path three times.
Experiments are carried out one unit with this 3 steps of walking as one unit per day.
Each time a part of the sensor and wireless communication is cut off to the input device and the output device when another person collides at an arbitrary timing.
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
85 years-old >=
Gender Male and Female
Key inclusion criteria Be able to walk with a white cane.
Independently using public transportation.
Key exclusion criteria It is not possible to walk with white canes due to causes other than visual impairment.
When you can not walk more than 3 m.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Akira
Middle name
Last name Kimura
Organization GUNMA PAZ UNIVERSITY
Division name Graduate School of Health Sciences
Zip code 3700006
Address Takasaki
TEL +818050153631
Email kimuaki@nifty.com

Public contact
Name of contact person
1st name Akira
Middle name
Last name Kimura
Organization GUNMA PAZ UNIVERSITY
Division name Graduate School of Health Sciences
Zip code 3700006
Address 1-7-1 Tonyamachi Taksaki Gunma Japan
TEL 0273653366
Homepage URL http://kimuakilabo.main.jp/osirase01.html
Email kimuaki@nifty.com

Sponsor
Institute Graduate School of Health Sciences, kimura akira lab
Institute
Department

Funding Source
Organization Japan Science and Technology Agency
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization JAPAN

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization GUNMA PAZ UNIVERSITY
Address 1-7-1 Tonyamachi Takasaki
Tel 0273653366
Email a-kimura@paz.ac.jp

Secondary IDs
Secondary IDs YES
Study ID_1 PAZ18-25
Org. issuing International ID_1 Gunma Pas University Ethics Review Committee
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 10 Month 25 Day

Related information
URL releasing protocol http://kimuakilabo.main.jp/osirase01.html
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 No longer recruiting
Date of protocol fixation
2018 Year 07 Month 04 Day
Date of IRB
Anticipated trial start date
2018 Year 08 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 10 Month 25 Day
Last modified on
2019 Year 04 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039507

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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