UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015156
Receipt number R000017627
Scientific Title Effects of mandibular vibrotactile feedback training on posture control in healthy volunteers
Date of disclosure of the study information 2014/11/01
Last modified on 2018/03/22 21:57:13

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Basic information

Public title

Effects of mandibular vibrotactile feedback training on posture control in healthy volunteers

Acronym

Effects of mandibular vibrotactile feedback training on posture control in healthy volunteers

Scientific Title

Effects of mandibular vibrotactile feedback training on posture control in healthy volunteers

Scientific Title:Acronym

Effects of mandibular vibrotactile feedback training on posture control in healthy volunteers

Region

Japan


Condition

Condition

vertigo

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

In the present study, an attempt was made to examine effects of mandibular vibrotactile feedback training on posture control in healthy volunteers. We evaluate changes in the accuracy of subjective visual vertical (SVV) and visual dependency of posture control after mandibular vibrotactile feedback of head tilt during daily performance.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The accuracy of subjective visual vertical (SVV) and visual dependency of posture control

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

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Mandibular vibrotactile feedback of head tilt during daily performance

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

Adult healthy volunteers without disequilibrium

Key exclusion criteria

Patients who were excluded by investigators

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Noriaki Takeda

Organization

University of Tokushima School of Medicine

Division name

Department of Otolaryngology

Zip code


Address

3-18-15 Kuramoto, Tokushima 770-8503, Japan

TEL

088-633-7169

Email

takeda@tokushima-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Noriaki Takeda

Organization

University of Tokushima School of Medicine

Division name

Department of Otolaryngology

Zip code


Address

3-18-15 Kuramoto, Tokushima 770-8503, Japan

TEL

088-633-7169

Homepage URL


Email

takeda@tokushima-u.ac.jp


Sponsor or person

Institute

University of Tokushima

Institute

Department

Personal name



Funding Source

Organization

Grant-in-Aid from Ministry of Health and Welfare of Japan

Organization

Division

Category of Funding Organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2014 Year 11 Month 01 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

Completed

Date of protocol fixation

2014 Year 09 Month 08 Day

Date of IRB


Anticipated trial start date

2014 Year 11 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 09 Month 14 Day

Last modified on

2018 Year 03 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017627


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name