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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000031669
Receipt No. R000036117
Scientific Title Development of rehabilitation for diziness handicaped using sound location, somatosensory, and vision
Date of disclosure of the study information 2018/03/12
Last modified on 2019/09/10

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Basic information
Public title Development of rehabilitation for diziness handicaped using sound location, somatosensory, and vision
Acronym Vestibular rehabilitation using multimodal sensation
Scientific Title Development of rehabilitation for diziness handicaped using sound location, somatosensory, and vision
Scientific Title:Acronym Vestibular rehabilitation using multimodal sensation
Region
Japan

Condition
Condition Peripheral vertigo
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We propose efficient exercise therapy using multimodal sensory inputs for vestibular dysfunction patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Gain and phase of vestibulo-ocular refrection in earth-vertical axis rotation and off--vertical axis rotation with stimulation of audition, somatosensory and vision
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Device,equipment
Interventions/Control_1 Subjects are stimulated by rotating chair with sinusoidal rotation on the earth vertical axis rotation and the off vertical axisrotation. The stimulation duration is 3 minutes for eye movement measurement and 15 minutes for adaptation. Measurements are conducted from 2 to 6 times, and the overall experiment time is from 1 hour to 1 hour 30 minutes.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Healthy adults who have never got otologistic symptoms
Key exclusion criteria Subject who shows symptoms of other than otological disease, judged that he or she can not participate in the examination, and judged that he or she is not healthy adults.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Izumi
Middle name
Last name Koizuka
Organization St. Marianna University School of Medicine
Division name Medical department, otorhinolaryngology
Zip code 216-8511
Address 2-16-1, Sugao, Miyamae-ku, Kawasaki 216-8511 Japan
TEL 044-977-8111
Email koizuka@marianna-u.ac.jp

Public contact
Name of contact person
1st name Yumiko
Middle name Ohno
Last name Kato
Organization St. Marianna University School of Medicine
Division name Medical department, otorhinolaryngology
Zip code 216-8511
Address 2-16-1, Sugao, Miyamae-ku, Kawasaki 216-8511 Japan
TEL 044-977-8111
Homepage URL
Email yumiko_o_kato@cwk.zaq.ne.jp

Sponsor
Institute St. Marianna University School of Medicine
Institute
Department

Funding Source
Organization St. Marianna University School of Medicine
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Tohoku University
Name of secondary funder(s)

IRB Contact (For public release)
Organization St. Marianna University School of Medicine
Address 2-16-1, Sugao, Miyamae-ku, Kawasaki 216-8511 Japan
Tel 044-977-8111
Email k-sienbu.mail@marianna-u.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
2018 Year 03 Month 12 Day

Related information
URL releasing protocol
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 Enrolling by invitation
Date of protocol fixation
2018 Year 03 Month 01 Day
Date of IRB
2007 Year 10 Month 26 Day
Anticipated trial start date
2018 Year 03 Month 19 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 03 Month 11 Day
Last modified on
2019 Year 09 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036117

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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