UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045842 |
|---|---|
| Receipt number | R000052334 |
| Scientific Title | Effect of video-based vestibular rehabilitation for patients with chronic dizziness: A randomized controlled study |
| Date of disclosure of the study information | 2021/10/22 |
| Last modified on | 2025/01/18 16:12:21 |
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Basic information
Public title
Effect of video-based vestibular rehabilitation for patients with chronic dizziness: A randomized controlled study
Acronym
Effect of video-based vestibular rehabilitation for patients with chronic dizziness: A randomized controlled study
Scientific Title
Effect of video-based vestibular rehabilitation for patients with chronic dizziness: A randomized controlled study
Scientific Title:Acronym
Effect of video-based vestibular rehabilitation for patients with chronic dizziness: A randomized controlled study
Region
| Japan |
Condition
Condition
patients with chronic dizziness
Classification by specialty
| Oto-rhino-laryngology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the effects of video-based vestibular rehabilitation in patients with chronic dizziness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Dizziness Handicap Inventory (DHI), Dynamic Gait Index (DGI)
Key secondary outcomes
Functional Gait Assessment (FGA)
vertigo symptom scale (VSS)
Dizziness-NRS
dynamic visual acuity (DVA)
mCTSIB
Timed up and go (TUG)
ABC scale
Hospital Anxiety and Depression Scale (HADS)
Video head impulse test (vHIT)
vestibular evoked myogenic potential (VEMP)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is 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
video-based vestibular rehabilitation
intervention period: 6 weeks
Interventions/Control_2
leaflet-based vestibular rehabilitation
intervention period: 6 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
patients with chronic dizziness
Key exclusion criteria
1.Patients with impaired cognitive function
2.Patients unable to perform vestibular rehabilitation at home
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tomohiko |
| Middle name | |
| Last name | Kamo |
Organization
Japan University of Health Sciences
Division name
School of Health Sciences
Zip code
340-0145
Address
2-555, Hirasuka, Satte-city, Saitama, 340-0145 Japan.
TEL
0480-48-5806
kamomoka0415@gmail.com
Public contact
Name of contact person
| 1st name | Tomohiko |
| Middle name | |
| Last name | Kamo |
Organization
Japan University of Health Sciences
Division name
School of Health Sciences
Zip code
340-0145
Address
2-555, Hirasuka, Satte-city, Saitama, 340-0145 Japan.
TEL
0480-48-5806
Homepage URL
kamomoka0415@gmail.com
Sponsor or person
Institute
mejiro university
Institute
Department
Personal name
Funding Source
Organization
JSPS KAKENHI
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethical Review Committee for Human and Animal Studies of Mejiro University
Address
320 Ukiya, Iwatsukiku, Saitama-shi, Saitama, 339-8501, Japan
Tel
048-797-2115
univsyomu@mejiro.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 10 | Month | 22 | 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
40
Results
In the DGI, an interaction was observed between the vestibular rehabilitation group (intervention group) that used videos and the vestibular rehabilitation group (control group) that used pamphlets.
In the DHI, a time effect was observed in the vestibular rehabilitation group (intervention group) that used videos and the vestibular rehabilitation group (control group) that used pamphlets.
Results date posted
| 2025 | Year | 01 | Month | 18 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Because it is taking a long time to get the paper accepted.
Date of the first journal publication of results
Baseline Characteristics
40 patients with peripheral vestibular disorders
Participant flow
The subjects were randomly divided into a video-based vestibular rehabilitation group (intervention group) and a pamphlet-based vestibular rehabilitation group (control group). They were assessed before and after the 6-week intervention, and 6 weeks after the intervention.
Adverse events
Minor dizziness and neck pain were reported, but there were no reports of adverse events that would have led to the discontinuation of vestibular rehabilitation.
Outcome measures
DGI, DHI
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 09 | Month | 20 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2022 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 01 | Month | 29 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 10 | Month | 22 | Day |
Last modified on
| 2025 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052334
