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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000039599
Receipt No. R000045133
Scientific Title Efficacy of vestibular rehabilitation on unilateral vestibular disorder, bilateral vestibular disorder, and persistent postural perceptual dizziness with intractable dizziness.
Date of disclosure of the study information 2020/02/25
Last modified on 2021/02/17

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Basic information
Public title Efficacy of vestibular rehabilitation on unilateral vestibular disorder, bilateral vestibular disorder, and persistent postural perceptual dizziness with intractable dizziness.
Acronym Efficacy of vestibular rehabilitation on unilateral vestibular disorder, bilateral vestibular disorder, and persistent postural perceptual dizziness with intractable dizziness.
Scientific Title Efficacy of vestibular rehabilitation on unilateral vestibular disorder, bilateral vestibular disorder, and persistent postural perceptual dizziness with intractable dizziness.
Scientific Title:Acronym Efficacy of vestibular rehabilitation on unilateral vestibular disorder, bilateral vestibular disorder, and persistent postural perceptual dizziness with intractable dizziness.
Region
Japan

Condition
Condition unilateral vestibular disorder, bilateral vestibular disorder, persistent postural perceptual dizziness
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of the study is to examine the difference in the effectiveness of vestibular rehabilitation for unilateral vestibular disorder, bilateral vestibular disorder, and persistent postural perceptual dizziness.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes dizziness handicap inventory
Key secondary outcomes Self-rating depression scale
Posturography
Single leg standing time
3m timed up & go test
Video head impulse test
Period required to improve the score of DHI
Brain activity measured by functional magnetic resonance imaging

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 1. Vestibular rehabilitation intervention for 8 weeks.
2. Vestibular rehabilitation intervention for up to 24 weeks if the improvement in the dizziness handicap inventory score is less than 18 point.
Interventions/Control_2 1. Vestibular rehabilitation intervention for 8 weeks.
2. Vestibular rehabilitation intervention for up to 24 weeks if the improvement in the dizziness handicap inventory score is less than 18 point.
Interventions/Control_3 1. Vestibular rehabilitation intervention for 8 weeks.
2. Vestibular rehabilitation intervention for up to 24 weeks if the improvement in the dizziness handicap inventory score is less than 18 point.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.Those whose video head impulse test result is 0.7 or less in at least 1 of the anterior, lateral, or posterior semicircular canals on unilateral.
2.Those whose video head impulse test result is 0.7 or less in at least 1 of the anterior, lateral, or posterior semicircular canals on bilateral.
3.Persons who meet all of the diagnostic criteria for PPPD (hereinafter A to E)
A.One or more symptoms of dizziness, unsteadiness, or non-spinning vertigo are present on most days for 3 months or more.
B.Persistent symptoms occur without specific provocation, but are exacerbated by three factors: Upright posture, active or passive motion without regard to direction or position, and exposure to moving visual stimuli or complex visual patterns.
C.The disorder is precipitated by conditions that cause vertigo, unsteadiness, dizziness, or problems with balance including acute, episodic, or chronic vestibular syndromes, other neurologic or medical illnesses, or psychological distress.
D.Symptoms cause significant distress or functional impairment.
E.Symptoms are not better accounted for by another disease or disorder.
Key exclusion criteria 1.Patients with structural abnormalities in MRI and MRA.
2.Patients who do not meet the diagnostic criteria for persistent postural perceptual dizziness and whose video head impulse test results in all semicircular canals are 0.7 or more.
3.Patients who are diagnosed with benign paroxysmal positional vertigo based on the results of the Dix-Hallpike test or roll test.
Target sample size 48

Research contact person
Name of lead principal investigator
1st name Satoshi
Middle name
Last name Tanaka
Organization Hamamatsu University School of Medicine
Division name Psychology
Zip code 431-3125
Address 1-20-1 Handayama Higashi-ku, Hamamatsu-city, Japan
TEL 053-453-2111
Email tanakas@hama-med.ac.jp

Public contact
Name of contact person
1st name Satoshi
Middle name
Last name Tanaka
Organization Hamamatsu University School of Medicine
Division name Psychology
Zip code 431-3125
Address 1-20-1 Handayama Higashi-ku, Hamamatsu-city, Japan
TEL 053-453-2111
Homepage URL
Email tanakas@hama-med.ac.jp

Sponsor
Institute Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Sakai neurosurgical clinic
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 053-453-2111
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 サカイ脳神経外科(静岡県)
Sakai neurosurgical clinic(Shizuoka)

Other administrative information
Date of disclosure of the study information
2020 Year 02 Month 25 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
2020 Year 02 Month 04 Day
Date of IRB
2020 Year 02 Month 04 Day
Anticipated trial start date
2020 Year 02 Month 25 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
2024 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 02 Month 25 Day
Last modified on
2021 Year 02 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045133

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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