UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Inquiry Search clinical trials

Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000027880
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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/
Email kimuaki@nifty.com

Sponsor
Institute Gunma PAZ University
Institute
Department

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
Email 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
URL(English) 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
Registered date File name

Research case data
Registered date File name


Contact us.