UMIN-CTR Clinical Trial

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
Last 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
1st 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://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031947