UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034973
Receipt number 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 2021/01/29 09:10:05

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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 or person

Institute

Hamamatsu university school of medicine

Institute

Department

Personal name



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

Completed

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

2021 Year 01 Month 29 Day



Link to view the page

Value
https://center6.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