UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039599 |
|---|---|
| Receipt number | 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 11:36:14 |
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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
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
tanakas@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045133
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