UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057202 |
|---|---|
| Receipt number | R000065366 |
| Scientific Title | User evaluation of "LOOVIC Unmanned Navigation Guide Barrier-Free" an audio guide helper application designed to support people with geographical disabilities |
| Date of disclosure of the study information | 2025/03/10 |
| Last modified on | 2026/03/28 16:26:56 |
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Basic information
Public title
User evaluation of "LOOVIC Unmanned Navigation Guide Barrier-Free" an audio guide helper application designed to support people with geographical disabilities
Acronym
User evaluation of the guide helper application "LOOVIC"
Scientific Title
User evaluation of "LOOVIC Unmanned Navigation Guide Barrier-Free" an audio guide helper application designed to support people with geographical disabilities
Scientific Title:Acronym
User evaluation of the guide helper application "LOOVIC"
Region
| Japan |
Condition
Condition
Spatial cognitive impairment, early-onset dementia, developmental disorders
Classification by specialty
| Rehabilitation medicine | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the application, strengths, and future issues of the guide helper application "LOOVIC Barrier-Free Unmanned Navigation Guide" that aims to support independence through intermediate and end user evaluations. By clarifying the application of this application and specifying areas for improvement, it will be possible to contribute to supporting the independent mobility of people with geographical disabilities.
Basic objectives2
Others
Basic objectives -Others
To clarify the app's effectiveness from the user's perspective
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Post-Study System Usability Questionnaire; PSSUQ(James.RLewis,1992)
Key secondary outcomes
users' feedback after using the app
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
| 6 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Survey 1: Doctors, nurses, physical therapists, occupational therapists, and caregivers from day care facilities who have experience providing medical support to two or more people with geographical disabilities working in rehabilitation wards.
Survey 2: The subjects must meet all six of the following conditions: 1) a person aged 6 or older (school age or older) with a geographical disability; 2) a person who needs to repeatedly go to the same place, and therefore needs training from a family member or supporter to go out independently; 3) a person who can go to a destination (within walking distance) when called out by a caregiver; 4) a person with visual, hearing, and language functions that do not interfere with daily life; 5) a person with sufficient physical and mental endurance and walking ability to travel to a destination. And 6) both the person and caregiver agree to participate in the study.
Key exclusion criteria
The exclusion criteria are that the person themselves has no geographical disabilities, has no desire to go out alone or has no difficulty going out, has easily divided attention and cannot concentrate, is unable to understand verbal instructions from others, behaves impulsively such as running out of nowhere, and has visual impairments or hemispatial neglect that interfere with walking.
Family caregivers are adults who have no physical or mental disabilities that interfere with daily life.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kaoru |
| Middle name | |
| Last name | Inoue |
Organization
Tokyo Metropolitan University
Division name
Faculty of Health Sciences
Zip code
1168551
Address
7-2-10, Higashiogu, Arakawa-ku, Tokyo
TEL
+81-3-3819-1211
inoue@tmu.ac.jp
Public contact
Name of contact person
| 1st name | Kaoru |
| Middle name | |
| Last name | Inoue |
Organization
Tokyo Metoropolitan University
Division name
The faculty of Health Scienses
Zip code
1168551
Address
7-2-10, Higashiogu, Arakawa-ku, Tokyo
TEL
03-3819-1211
Homepage URL
inoue@tmu.ac.jp
Sponsor or person
Institute
Tokyo Metropolitan University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan University
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Metropolitan University
Address
7-2-10, Higashiogu, Arakawa-ku, Tokyo
Tel
03-3819-1211
inoue@tmu.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
関東地方在住の研究対象者を対象とする
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 03 | Month | 10 | 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
Completed
Date of protocol fixation
| 2024 | Year | 04 | Month | 16 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 14 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 02 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2025 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2025 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2025 | Year | 09 | Month | 30 | Day |
Other
Other related information
We are developing a navigation app for people with topographical disabilities. Medical professionals and other healthcare staff, family members, and people with disabilities will use the app and provide feedback on their impressions. Based on this information, we will clarify the issues facing the app.
Management information
Registered date
| 2025 | Year | 03 | Month | 04 | Day |
Last modified on
| 2026 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065366
