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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000042739
Receipt No. R000048785
Scientific Title Research on the utilization of information devices to support social distancing for the blind People
Date of disclosure of the study information 2020/12/25
Last modified on 2020/12/13

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Basic information
Public title A Study of Equipment Accessibility for Social Distancing of the Blind People
Acronym EASDB
Scientific Title Research on the utilization of information devices to support social distancing for the blind People
Scientific Title:Acronym EASDB
Region
Japan

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

Objectives
Narrative objectives1 To learn how to utilize commercially available IoT devices for the blind, including acquisition of devices, device settings, preparation of voice applications, design of information processing software programs, and actual device operation, and to clarify the conditions for success or failure until the devices can be utilized.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The time it takes to acquire the ability to operate these devices from the starting point of being able to use a smartphone (the time threshold for subjective utility satisfaction).
Key secondary outcomes Success or failure of operation and time required for learning by regression model with autonomic function HF/LF ratio as dependent variable and categorized explanatory variables of age, smartphone operation ability, spatial awareness, short-term memory, operation error event, and recognition difficulty event.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
40 years-old <
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria Over 40 years old.
Blind People.
Not in hospital.
Must be a local resident living at home.
Must be able to move indoors and outdoors alone.
Must be able to understand and follow movement instructions.
Key exclusion criteria Under 40 years old.
Persons with visual function.
Undergoing inpatient treatment.
Not living at home in the community at the time of measurement.
Unable to move indoors and outdoors by himself.
Unable to understand movement instructions.
Target sample size 8

Research contact person
Name of lead principal investigator
1st name Akira
Middle name Kimura
Last name Kimura
Organization Gunma Paz University
Division name Division of Physical Therapy
Zip code 3700006
Address 1-7-1 Tonyamachi,Takasaki
TEL 0273880865
Email kimuaki@nifty.com

Public contact
Name of contact person
1st name Akira
Middle name
Last name Kimura
Organization GUNMA PAZ UNIVERSITY
Division name Division of Physical Therapy
Zip code 3700004
Address Takasaki
TEL 08050153631
Homepage URL http://kimuakilabo.main.jp/
Email kimuaki@nifty.com

Sponsor
Institute KIMUAKILABO,Gunma Paz University
Institute
Department

Funding Source
Organization KIMUAKILABO,Gunma Paz University
Organization
Division
Category of Funding Organization Self funding
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, Gunma
Tel 0273880865
Email a-kimura@paz.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 12 Month 25 Day

Related information
URL releasing protocol http://kimuakilabo.main.jp/
Publication of results Unpublished

Result
URL related to results and publications http://kimuakilabo.main.jp/
Number of participants that the trial has enrolled 8
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
2020 Year 07 Month 01 Day
Date of IRB
2020 Year 07 Month 27 Day
Anticipated trial start date
2020 Year 09 Month 01 Day
Last follow-up date
2021 Year 01 Month 15 Day
Date of closure to data entry
2021 Year 01 Month 22 Day
Date trial data considered complete
2021 Year 01 Month 29 Day
Date analysis concluded
2021 Year 02 Month 04 Day

Other
Other related information After an audio demonstration (5 minutes, only one trial before the validation was conducted)
After a 5-minute audio demonstration (only one trial before the verification was conducted), the minimum time threshold for satisfaction based on listening for the presence or absence of a subjective sense of utility was determined.

Management information
Registered date
2020 Year 12 Month 13 Day
Last modified on
2020 Year 12 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048785

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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