UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027880 |
|---|---|
| Receipt number | R000031947 |
| Scientific Title | Combined evaluation of electrical stimulation alert to encourage danger avoidance operation when blind person moves |
| Date of disclosure of the study information | 2017/06/23 |
| Last modified on | 2019/04/26 17:44:08 |
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Basic information
Public title
Combined evaluation of electrical stimulation alert to encourage danger avoidance operation when blind person moves
Acronym
Electrical stimulation alert study for blind people
Scientific Title
Combined evaluation of electrical stimulation alert to encourage danger avoidance operation when blind person moves
Scientific Title:Acronym
Electrical stimulation alert study for blind people
Region
| Japan |
Condition
Condition
Blind person
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Attempt to introduce new alert technology to avoid blind persons off station platform falling accident. At the same time, it is not only to confirm the effectiveness quantitatively, but also to carry out nursing and rehabilitation evaluation to raise user satisfaction.
Basic objectives2
Others
Basic objectives -Others
Before recognizing the dangers of blind persons, evaluate the performance of moving the center of gravity from the danger point and evaluate usability
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Presence or absence of movement to the danger avoidance position immediately after object contact
Key secondary outcomes
Autonomic nervous system function (HF / LF ratio) immediately after object contact
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Acceleration sensing,Human sensor activation type Functional electrical stimulation Electrical stimulation by alert device (energizing alert)(Randomly run sensors responsive to contact of random objects three times of six times for participants to walk walking simulated platform of 5m.)
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
It is possible to stand alone with a white cane.
Key exclusion criteria
It is impossible to walk alone with a white cane.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Kimura |
Organization
Gunma PAZ University
Division name
Department of Health Sciences
Zip code
3700006
Address
1-7-1 Tonyamachi Takasaki Gunma, Japan
TEL
027-388-0865
kimuaki@nifty.com
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Kimura |
Organization
Gunma PAZ University
Division name
Department of Health Sciences
Zip code
3700006
Address
1-7-1 Tonyamachi Takasaki Gunma, Japan
TEL
027-388-0865
Homepage URL
http://kimuakilabo.main.jp/
kimuaki@nifty.com
Sponsor or person
Institute
Gunma PAZ University
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 Gunma
Tel
0273653366
a-kimura@paz.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
16-6
Org. issuing International ID_1
Gunma PAZ University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
群馬パース大学（群馬県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 06 | Month | 23 | Day |
Related information
URL releasing protocol
http://kimuakilabo.main.jp/
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
| 2017 | Year | 07 | Month | 14 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 14 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 15 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 23 | Day |
Last modified on
| 2019 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031947
| Research Plan | |
|---|---|
| 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 |
