UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063625 |
|---|---|
| Receipt number | R000072811 |
| Scientific Title | Evaluation of the Usefulness of an Indoor Navigation System in a Hospital Setting |
| Date of disclosure of the study information | 2026/11/13 |
| Last modified on | 2026/11/13 17:20:58 |
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Basic information
Public title
A Study of the Usefulness of an Indoor Navigation Application for Moving Around a Hospital
Acronym
Study of an Indoor Navigation App
Scientific Title
Evaluation of the Usefulness of an Indoor Navigation System in a Hospital Setting
Scientific Title:Acronym
Study of an Indoor Navigation App
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate the effects of the indoor navigation application "IndoorFlow" on navigation behavior and route selection among individuals unfamiliar with a hospital environment, and to assess its usefulness and impact on perceived reassurance in a medical facility.
Healthy volunteers who have never entered Keio University Hospital will be enrolled. Navigation behavior and subjective evaluations will be compared between conditions with and without the application.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary outcome measures are the following three indicators of smooth indoor navigation:
1.Number of steps
2.Travel time
3.Number of stops
These outcomes will be measured during each navigation trial under both conditions (with and without the indoor navigation application "IndoorFlow") and compared between the two conditions.
Key secondary outcomes
The secondary outcome measures consist of the following two assessments:
1) Route-related assessment
The presence and nature of navigation errors will be assessed during each navigation trial. A navigation error is defined as taking an incorrect route that results in backtracking or a substantial detour while traveling to the destination. For each trial, the presence of a navigation error will be recorded as 1 (yes) or 0 (no). If a navigation error occurs, its details will be documented.
2) Subjective assessment
Changes in perceived reassurance regarding indoor navigation before and after using the application will be assessed using a self-administered questionnaire.
Assessment timing: Route-related assessments will be conducted during each navigation trial, and subjective assessments will be conducted before and after the walking trials.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Intervention 1 (Group A-1):
Participants will navigate Route 1 using the indoor navigation application "IndoorFlow," followed by a 15-minute rest period. They will then navigate Route 2 without using the application.
Interventions/Control_2
Intervention 2 (Group A-2):
Participants will navigate Route 2 using "IndoorFlow," followed by a 15-minute rest period. They will then navigate Route 1 without using the application.
Interventions/Control_3
Intervention 3 (Group B-1):
Participants will navigate Route 1 without using "IndoorFlow," followed by a 15-minute rest period. They will then navigate Route 2 using the application.
Interventions/Control_4
Intervention 4 (Group B-2):
Participants will navigate Route 2 without using "IndoorFlow," followed by a 15-minute rest period. They will then navigate Route 1 using the application.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Eligible participants will be healthy volunteers who have never entered the Keio University Hospital building, meet all of the following inclusion criteria, and do not meet any of the exclusion criteria.
1.Healthy volunteers who have never entered the Keio University Hospital building.
2.Individuals who can walk independently within the hospital without assistance from others.
3.Individuals who are capable of performing basic smartphone operations.
4.Individuals who can understand the study procedures and provide written informed consent voluntarily.
Key exclusion criteria
Individuals who are unable to understand the assessments and study procedures.
Individuals who have difficulty walking independently within the hospital without assistance.
Individuals deemed unsuitable for participation in the study by the principal investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Toshihide |
| Middle name | |
| Last name | Kurihara |
Organization
Keio University School of Medicine
Division name
Department of Ophthalmology
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5315-4132
kurihara.z8@keio.jp
Public contact
Name of contact person
| 1st name | Kimie |
| Middle name | |
| Last name | Kamata |
Organization
Keio University School of Medicine
Division name
Department of Ophthalmology
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5315-4132
Homepage URL
kimiekamata@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Toshihide Kurihara
Funding Source
Organization
Ashirase Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
03-3353-1211
med-rinri-jimu@adst.keio.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
| 2026 | Year | 11 | Month | 13 | 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
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
Preinitiation
Date of protocol fixation
| 2026 | Year | 11 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2027 | Year | 01 | Month | 14 | Day |
Last follow-up date
| 2027 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 11 | Month | 13 | Day |
Last modified on
| 2026 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072811
