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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000034973
Receipt No. R000039877
Scientific Title The relationship between subjective direction of body longitudinal axis and body tilt sensation
Date of disclosure of the study information 2018/11/22
Last modified on 2019/07/11

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Basic information
Public title The relationship between subjective direction of body longitudinal axis and body tilt sensation
Acronym The relationship between subjective direction of body longitudinal axis and body tilt sensation
Scientific Title The relationship between subjective direction of body longitudinal axis and body tilt sensation
Scientific Title:Acronym The relationship between subjective direction of body longitudinal axis and body tilt sensation
Region
Japan

Condition
Condition healthy adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to investigate the causal relationship between perceived direction of body longitudinal axis and body tilt sensation using whole-body tilt
Basic objectives2 Others
Basic objectives -Others Assessment of the alteration of subjective direction of body longitudinal axis depending on the body angle in the roll plane
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase

Assessment
Primary outcomes subjective body tilt angle
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Lateral whole-body tilt
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
60 years-old >
Gender Male and Female
Key inclusion criteria 1. Individuals without a neurological or psychiatric history
2. Right handedness
3. Capability of informed consent based on their own decision
Key exclusion criteria 1. Individuals with a history of head trauma
2. Individuals with a history of organic brain and spinal disease
3. Individuals with a history or organic vestibular disease
4. Individuals who have a history of disorders of consciousness and/or seizure
5. Individuals with dizziness and strong motion sickness
6. Individuals that researchers decide that they are inappropriate for study participation
Target sample size 12

Research contact person
Name of lead principal investigator
1st name Satoshi
Middle name
Last name Tanaka
Organization Hamamatsu univesity school of medicine
Division name psychology
Zip code 431-3192
Address 1-20-1 Handayama Higashi-ku, Hamamatsu-city, Japan
TEL 053-453-2387
Email tanakas@hama-med.ac.jp

Public contact
Name of contact person
1st name Satoshi
Middle name
Last name Tanaka
Organization Hamamatsu univesity school of medicine
Division name psychology
Zip code 431-3192
Address 1-20-1 Handayama Higashi-ku, Hamamatsu-city, Japan
TEL 053-453-2387
Homepage URL
Email tanakas@hama-med.ac.jp

Sponsor
Institute Hamamatsu university school of medicine
Institute
Department

Funding Source
Organization Hamamatsu university school of medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Hamamatsu University School of Medicine
Address 1-20-1 Handayama Higashi-ku, Hamamatsu-city, Japan
Tel 0534532387
Email tanakas@hama-med.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 11 Month 22 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 10
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 No longer recruiting
Date of protocol fixation
2018 Year 09 Month 25 Day
Date of IRB
2018 Year 10 Month 31 Day
Anticipated trial start date
2018 Year 11 Month 26 Day
Last follow-up date
2020 Year 09 Month 01 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 11 Month 22 Day
Last modified on
2019 Year 07 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039877

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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