UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043885 |
|---|---|
| Receipt number | R000050110 |
| Scientific Title | Effect of Vestibular Rehabilitation by Physical Therapist for Patients with Dizziness or Vertigo: Randomized controlled trials |
| Date of disclosure of the study information | 2021/06/01 |
| Last modified on | 2022/01/03 20:25:17 |
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Basic information
Public title
Effect of Vestibular Rehabilitation by Physical Therapist for Patients with Dizziness or Vertigo: Randomized controlled trials
Acronym
Vestibular Rehabilitation by Physical Therapist
Scientific Title
Effect of Vestibular Rehabilitation by Physical Therapist for Patients with Dizziness or Vertigo: Randomized controlled trials
Scientific Title:Acronym
Vestibular Rehabilitation by Physical Therapist
Region
| Japan |
Condition
Condition
Dizziness, Vertigo
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of vestibular rehabilitation by physical therapists in patients with dizziness compared to home vestibular rehabilitation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Dizziness Handicap Inventory; DHI at 3 months
Key secondary outcomes
Vertigo Symptom Scale-short form: VSS-sf
Hospital Anxiety and Depression Scale: HADS
Niigata PPPD Questionnaire: NPQ
Petrography
Timed Up and Go Test; TUG Test
Walking speed
Dynamic Gait Index, Functional Gait Assessment
Motion Sensitivity Quotient
at 3 months
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
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Vestibular Rehabilitation by Physical Therapist
Interventions/Control_2
TAU (home vestibular rehabilitation only)
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
1) peripheral vestibular disorder or functional vestibular disorder
2)DHI 31 points or higher
Key exclusion criteria
1) experience of vestibular rehabilitation
2) Inability to perform vestibular rehabilitation (physical or mental reasons)
3) Visual impairment
4) Decreased cognitive function
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Kayoko |
| Middle name | |
| Last name | Kabaya |
Organization
Nagoya City University Graduate School of medical science
Division name
Department of Otorhinolaryngology and Head & Neck Surgery
Zip code
467-8602
Address
1 Kawasumi Mizuho-cho Mizuho-ku Nagoya
TEL
0528538256
kabaya@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Kayoko |
| Middle name | |
| Last name | Kabaya |
Organization
Nagoya City University Graduate School of medical science
Division name
Department of Otorhinolaryngology and Head & Neck Surgery
Zip code
467-8602
Address
1 Kawasumi Mizuho-cho Mizuho-ku Nagoya
TEL
0528538256
Homepage URL
kabayakayoko@gmail.com
Sponsor or person
Institute
Nagoya City University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Clinical Research Management center, Nagoya City University Hospital
Address
1 Kawasumi Mizuho-cho Mizuho-ku
Tel
0528538256
clinical_research@med.nagoya-cu.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
名古屋市立大学病院
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 06 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 04 | Month | 10 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 07 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 04 | Month | 10 | Day |
Last modified on
| 2022 | Year | 01 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050110
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
