UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034652 |
|---|---|
| Receipt number | R000039507 |
| Scientific Title | Combined evaluation of energizing alerts to encourage danger avoidance operation when blind persons move-2 |
| Date of disclosure of the study information | 2018/10/25 |
| Last modified on | 2023/05/12 14:36:35 |
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Basic information
Public title
Combined evaluation of energizing alerts to encourage danger avoidance operation when blind persons move-2
Acronym
Energizing alert test
Scientific Title
Combined evaluation of energizing alerts to encourage danger avoidance operation when blind persons move-2
Scientific Title:Acronym
Energizing alert test
Region
| Japan |
Condition
Condition
Blind person
Classification by specialty
| Ophthalmology | Rehabilitation medicine | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to avoid the type of falling platform platform fall accident, based on the result of carrying out the experiment to introduce the newly developed electrification alert (warning) technology in FY 2017, further clarify the success rate .
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Success rate of the intervention condition (when the device is driven) against the control condition (the device does not operate)
Key secondary outcomes
Movie being tried, heart rate (RR interval, HR), accelerometer value attached to the body, record of instruction contents, Likert scale between sense of fear before and after trial, time required for trial
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Process the signal of the sensor that detects the approach of the human body, replace it with the energizing signal, and inform the blind person of the danger.
The case walks 3 meters walking path three times.
Experiments are carried out one unit with this 3 steps of walking as one unit per day.
Each time seamlessly connects the sensor and wireless communication when the other person collides at an arbitrary timing to the input device and the output device.
Interventions/Control_2
Process the signal of the sensor that detects the approach of the human body, replace it with the energizing signal, do not let the blind person know the danger.
The case walks 3 meters walking path three times.
Experiments are carried out one unit with this 3 steps of walking as one unit per day.
Each time a part of the sensor and wireless communication is cut off to the input device and the output device when another person collides at an arbitrary timing.
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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Be able to walk with a white cane.
Independently using public transportation.
Key exclusion criteria
It is not possible to walk with white canes due to causes other than visual impairment.
When you can not walk more than 3 m.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Kimura |
Organization
GUNMA PAZ UNIVERSITY
Division name
Graduate School of Health Sciences
Zip code
3700006
Address
Takasaki
TEL
+818050153631
kimuaki@nifty.com
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Kimura |
Organization
GUNMA PAZ UNIVERSITY
Division name
Graduate School of Health Sciences
Zip code
3700006
Address
1-7-1 Tonyamachi Taksaki Gunma Japan
TEL
0273653366
Homepage URL
http://kimuakilabo.main.jp/osirase01.html
kimuaki@nifty.com
Sponsor or person
Institute
Graduate School of Health Sciences, kimura akira lab
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
Tel
0273653366
a-kimura@paz.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
PAZ18-25
Org. issuing International ID_1
Gunma Pas University Ethics Review Committee
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 10 | Month | 25 | Day |
Related information
URL releasing protocol
http://kimuakilabo.main.jp/osirase01.html
Publication of results
Partially published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/jjphpt/6/2/6_7/_pdf/-char/en
Number of participants that the trial has enrolled
10
Results
: Eight participants were successful in setting up the equipment and environment during the experiment.
The result was an 77.3% success rate, which was significantly higher when comparing device performance in control conditions.
Eight among 10 trials were successful in the intervention condition, and 29 out of 46 were failed in the control condition
Results date posted
| 2021 | Year | 04 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 03 | Month | 31 | Day |
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
| 2018 | Year | 07 | Month | 04 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 06 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 06 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 10 | Month | 25 | 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=R000039507
| Research Plan | |
|---|---|
| Registered date | File name |
| 2021/04/28 | 研究計画書ー通電アラート.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2021/04/28 | 研究データベース定義書.xlsx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2021/04/28 | AAC09_DATA.xlsx |
