UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042739 |
|---|---|
| Receipt number | 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 | 2023/05/12 15:05:01 |
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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
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/
kimuaki@nifty.com
Sponsor or person
Institute
KIMUAKILABO,Gunma Paz University
Institute
Department
Personal name
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
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
https://ipsj.ixsq.nii.ac.jp/ej/?action=pages_view_main&active_action=repository_view_main_item_detai
Publication of results
Partially published
Result
URL related to results and publications
https://ipsj.ixsq.nii.ac.jp/ej/?action=pages_view_main&active_action=repository_view_main_item_detai
Number of participants that the trial has enrolled
20
Results
The results showed that n=20 participants. There were 12 censored cases. The endpoint was reached by 8 participants, with a
reach rate of 40%. Among the outcomes, significant effects were the presence or absence of information literacy (p<.05) and the
effect of age (<75 years and above) (p<.15)
Results date posted
| 2023 | Year | 05 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 08 | Month | 29 | Day |
Baseline Characteristics
Subjects were middle-aged (40 years and
older) visually impaired people (n=20) living in Kusatsu-machi, Gunma Prefecture. Participants were required to walk and live
independently using a white cane. The study design was a 5-year cohort study. The endpoint was "confidence in one's own health"
(none to yes). Outcomes were age, gender, height, weight, body composition, self-health building confidence (confidence to live
longer), information literacy collection sources and use, and time of blindness. Statistical analysis
Participant flow
e. Participants were required to walk and live
independently using a white cane. The study design was a 5-year cohort study. The endpoint was "confidence in one's own health"
(none to yes).
Adverse events
No Finding
Outcome measures
The results showed that n=20 participants. There were 12 censored cases. The endpoint was reached by 8 participants, with a
reach rate of 40%. Among the outcomes, significant effects were the presence or absence of information literacy (p<.05) and the
effect of age (<75 years and above) (p<.15).
It indicates that there may be an age-related marginal point at which the cumulative effect comes to a head in supporting improved
information literacy in the effect of self-health building confidence in visually impaired people living in a mountainous area over
a 5-year period. Comprehensive health information literacy support that includes an age-related limit point appears to be important.
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
| 2023 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048785
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
