UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004940 |
|---|---|
| Receipt number | R000005881 |
| Scientific Title | The effect of individualized rehabilitation using vibrotactile feedback system (Vertiguard) for the patients with chronic dizziness |
| Date of disclosure of the study information | 2011/01/26 |
| Last modified on | 2011/01/25 07:51:15 |
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Basic information
Public title
The effect of individualized rehabilitation using vibrotactile feedback system (Vertiguard) for the patients with chronic dizziness
Acronym
The effect of individualized rehabilitation for the patients with chronic dizziness
Scientific Title
The effect of individualized rehabilitation using vibrotactile feedback system (Vertiguard) for the patients with chronic dizziness
Scientific Title:Acronym
The effect of individualized rehabilitation for the patients with chronic dizziness
Region
| Japan |
Condition
Condition
Presbystasis
Unilateral canal dysfunction
Bilateral canal dysfunction
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effect of individualized rehabilitation using vibrotactile feedback system (Vertiguard) for the patients with chronic dizziness
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Measurement with Vertiguard
Static posturography
Key secondary outcomes
Fukuda's stepping test
Dizziness handicap inventory
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
Individualized rehabilitation with Vertiguard
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Subjects who understand the objective and contents of the study
Possible to stand alone
Possible to visit hospital regular bases
Key exclusion criteria
Age under 20
DM
Impossible to stand alone for 60 seconds with eyes close
Impossible to visit hospital regular bases
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fumiyuki Goto |
Organization
Keio university
Division name
otolaryngology
Zip code
Address
35 Shinanomachi Shinjukuku Tokyo Japan 160-8520
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Keio university
Division name
otolaryngology
Zip code
Address
TEL
Homepage URL
amifumi@bc5.so-net.ne.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2011 | Year | 01 | Month | 26 | 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
Preinitiation
Date of protocol fixation
| 2011 | Year | 01 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | 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
| 2011 | Year | 01 | Month | 25 | Day |
Last modified on
| 2011 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005881
