UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055826 |
|---|---|
| Receipt number | R000063796 |
| Scientific Title | Efficacy of vestibular rehabilitation for patients with peripheral vestibular disorders. |
| Date of disclosure of the study information | 2024/11/01 |
| Last modified on | 2024/10/14 10:01:16 |
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Basic information
Public title
Efficacy of vestibular rehabilitation for patients with peripheral vestibular disorders.
Acronym
Efficacy of vestibular rehabilitation
Scientific Title
Efficacy of vestibular rehabilitation for patients with peripheral vestibular disorders.
Scientific Title:Acronym
Efficacy of vestibular rehabilitation
Region
| Japan |
Condition
Condition
Vestibular neuritis, Meniere's disease, vestibular migraine, BPPV, perilymph fistula, PPPD, vestibular decompensation cases
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A comparative trial will demonstrate the effectiveness of vestibular rehabilitation for patients with dizziness and balance disorders due to vestibular disorders. This makes it possible to develop an effective treatment for vestibular decompensation (vertigo sequelae) for which there is no effective drug treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
DHI (Dizziness handicap Inventory) before starting vestibular rehabilitation, 4 weeks after starting, 8 weeks after starting, and 16 weeks after starting vestibular rehabilitation
Key secondary outcomes
ABCscale, HADS, neurootological test findings (nystagmus test, center of gravity sway test, vHIT), rehabilitation-related tests GES, NPQ, quadriceps muscle strength, before the start of vestibular rehabilitation, 4 weeks after the start, and 8 weeks after the start. , 10m walk test, TUG, circumferential walk test, cross-legged walk test, FGA (a version that adds three tests to DGI), and V-VAS (a test that quantifies the degree of dizziness)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
PT intervention vestibular rehabilitation group: PT conducted interviews and evaluation for 10 minutes per session, provided 20 minutes of motor training (head movement, balance, walking, habituation: according to vestibular rehabilitation guidelines), and provided 10 minutes of advice (home exercise guidance, etc.) Do this for minutes. Instruct children to do home exercises at home for at least 20 minutes at a time, three times a day. After seeing the patient once every two weeks, vestibular rehabilitation with PT intervention is performed.
Interventions/Control_2
Home exercise group: 10 minutes of advice (such as instruction on home exercises) and vestibular rehabilitation at home. Instruct children to do home exercises at home for at least 20 minutes at a time, three times a day. Medical examinations are performed only once every two weeks.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Target patients with dizziness and balance disorders accompanied by vestibular disorders who visited Ogaki Tokushukai Hospital Otolaryngology Head and Neck Surgery/Dizziness and Hearing Loss Center by December 2025.
Selection criteria
Applicable to those who meet all of the following criteria:
1) Vestibular symptoms for more than 3 months
2) Resistant to existing treatments
3) Vestibular neuritis, Meniere's disease, vestibular migraine, Benign Paroxysmal Positional Vertigo (BPPV), perilymph fistula, Persistent Postural Perceptual Dizziness (PPPD), vestibular Diagnosed with a peripheral vestibular disorder such as impaired decompensation
4) DHI score of 36 points or higher (severity must be moderate or higher)
5) Patients who are 20 years of age or older at the time of obtaining consent (gender does not matter, no upper age limit is set)
6) Research subjects who have given their voluntary written consent to participate in this research after receiving sufficient explanation.
7) Outpatient
Key exclusion criteria
Those who meet any of the following criteria will not be included in this study.
1) Patients with a history of cerebrovascular disease (excluding asymptomatic lacunar infarction)
2) Patients with lower limb movement disorders due to knee osteoarthritis, etc.
3) Patients who have difficulty understanding and carrying out vestibular rehabilitation due to dementia, etc.
4) Patients who the principal investigator judges to be inappropriate as study subjects.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Mitsuhiro |
| Middle name | |
| Last name | Aoki |
Organization
Ogaki Tokushukai Hospital
Division name
Deparftment of Otolaryngology
Zip code
503-0015
Address
6-85, Hayashi-machi, Ogaki City, Gifu
TEL
0584-77-6616
mitsuhiro.aoki@tokushukai.jp
Public contact
Name of contact person
| 1st name | Kazuya |
| Middle name | |
| Last name | Matsuoka |
Organization
Ogaki Tokushukai Hospital
Division name
Rehabilitaion section
Zip code
503-0015
Address
6-85, Hayashi-machi, Ogaki City, Gifu
TEL
0584-77-6616
Homepage URL
mitsuhiro.aoki@tokushukai.jp
Sponsor or person
Institute
Ogaki Tokushukai Hospital
Institute
Department
Personal name
Mitsuhiro Aoki
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
Ogaki Tokushukai Hospital
Address
6-85, Hayashi-machi, Ogaki City, Gigu
Tel
0584-77-6110
mitsuhiro.aoki@tokushukai.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
大垣徳洲会病院
Other administrative information
Date of disclosure of the study information
| 2024 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 10 | Month | 14 | Day |
Last modified on
| 2024 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063796
