UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055925 |
|---|---|
| Receipt number | R000063908 |
| Scientific Title | Effects of Acute Vestibular Rehabilitation on Peripheral Vestibular Disorders -A Randomized Controlled Trial- |
| Date of disclosure of the study information | 2024/10/25 |
| Last modified on | 2025/04/24 11:32:52 |
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Basic information
Public title
Effects of Acute Vestibular Rehabilitation on Peripheral Vestibular Disorders -A Randomized Controlled Trial-
Acronym
Effects of Acute Vestibular Rehabilitation on Peripheral Vestibular Disorders -A Randomized Controlled Trial-
Scientific Title
Effects of Acute Vestibular Rehabilitation on Peripheral Vestibular Disorders -A Randomized Controlled Trial-
Scientific Title:Acronym
Effects of Acute Vestibular Rehabilitation on Peripheral Vestibular Disorders -A Randomized Controlled Trial-
Region
| Japan |
Condition
Condition
Unilateral Peripheral Vestibular Disorder
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of early vestibular rehabilitation initiated during the acute phase on balance function, gait function, and activities of daily living associated with vestibular disorders.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
-Dizziness Handicap Inventory
-Functional Gait Assessment
-Timed Up and Go Test
-modified Clinical Test Sensory Interaction and Balance (Using a stabilometer, simultaneously evaluate the sway velocity, trajectory length, outer area, and Romberg ratio under each condition)
-Nystagmus
Time of assessment:immediately before the in tervention, 1 week, 1 month, 2 months, 3 months from onset
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Individual vestibular rehabilitation by a physical therapist for 40 minutes once during the hospitalization period.
Interventions/Control_2
No intervention by physical therapists as in the past.
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patient must be in the acute to subacute phase (within 1 month of onset) of a disease that produces peripheral vestibular disorders, within 1 month of the onset of vertigo exacerbation, and must have an understanding and consent for the study.
Key exclusion criteria
Those who originally required assistance in daily living and those who could not give consent for the research.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yuina |
| Middle name | |
| Last name | Sano |
Organization
Fujinomiya City General Hospital
Division name
Department of Rehabilitation, Medical Technology Department
Zip code
4180076
Address
3-1 Nishiki-cho, Fujinomiya City, Shizuoka, Japan
TEL
0544-27-3151
yuina.sano@outlook.jp
Public contact
Name of contact person
| 1st name | Yuina |
| Middle name | |
| Last name | Sano |
Organization
Fujinomiya City General Hospital
Division name
Department of Rehabilitation, Medical Technology Department
Zip code
4180076
Address
3-1 Nishiki-cho, Fujinomiya City, Shizuoka, Japan
TEL
0544-27-3151
Homepage URL
yuina.sano@outlook.jp
Sponsor or person
Institute
Fujinomiya City General Hospital
Institute
Department
Personal name
Funding Source
Organization
Fujinomiya City General Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fujinomiya City General Hospital
Address
3-1 Nishiki-cho, Fujinomiya City, Shizuoka, Japan
Tel
0544-27-3151
h-kanri@city.fujinomiya.lg.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | 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
| 2024 | Year | 10 | Month | 23 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 03 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | 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 | 23 | Day |
Last modified on
| 2025 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063908
