UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000054508
Receipt number R000062279
Scientific Title Study of a mobility aid application for the visually impaired
Date of disclosure of the study information 2024/05/31
Last modified on 2024/12/24 13:15:30

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Basic information

Public title

Accessibility Survey for the Visually Impaired (Preliminary Survey)

Acronym

Support for the Visually Impaired

Scientific Title

Study of a mobility aid application for the visually impaired

Scientific Title:Acronym

EyeNaviStudy1

Region

Japan


Condition

Condition

visually impaired person

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The vast Nishi-Chiba Campus, the headquarters of Chiba University, is not designed for the visually impaired. The surrounding area is well-equipped with Braille blocks. Chiba University, as a university that promotes diversity, needs to create a campus environment that is friendly to the visually impaired by improving flow lines, such as steps, and installing voice guidance systems. However, the development of infrastructure requires an enormous budget. The purpose of this project is to have able-bodied volunteers act as simulated visually impaired people and use a mobility support application to list obstacles that the application cannot recognize.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Experience using a mobility aid application with a simulated visually impaired person (exploratory study)

Key secondary outcomes



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

18 years-old <=

Age-upper limit

80 years-old >

Gender

Male and Female

Key inclusion criteria

able-bodied volunteer

Key exclusion criteria

Persons with any kind of physical disability

Target sample size

5


Research contact person

Name of lead principal investigator

1st name Takeshi
Middle name
Last name Sugawara

Organization

Chiba University Hospital

Division name

Ophthalmology

Zip code

2630024

Address

Chiba City, Chuo-ku, Inohana 1-8-1

TEL

0432262484

Email

takeshis@faculty.chiba-u.jp


Public contact

Name of contact person

1st name Takeshi
Middle name
Last name Sugawara

Organization

Chiba University Hospital

Division name

Ophthalmology

Zip code

2630024

Address

Chiba City, Chuo-ku, Inohana 1-8-1

TEL

0432262484

Homepage URL


Email

takeshis@faculty.chiba-u.jp


Sponsor or person

Institute

Chiba University Hospital

Institute

Department

Personal name



Funding Source

Organization

MEXT

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Chiba University Hospital

Address

Chiba City, Chuo-ku, Inohana 1-8-1

Tel

0432227171

Email

takeshis@faculty.chiba-u.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

2024 Year 05 Month 31 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

0

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

2024 Year 03 Month 06 Day

Date of IRB

2024 Year 05 Month 22 Day

Anticipated trial start date

2024 Year 06 Month 01 Day

Last follow-up date

2024 Year 09 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Five healthy volunteers will be fitted with eye masks and asked to move around the Nishi-Chiba campus in an environment accompanied by the principal investigator, relying on Eye Navi, a walking assistance application for the visually impaired, to list obstacles that the application cannot recognize.


Management information

Registered date

2024 Year 05 Month 30 Day

Last modified on

2024 Year 12 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062279