UMIN-CTR Clinical Trial

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
Email	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
Email	kabayakayoko@gmail.com

Sponsor
Institute	Nagoya City University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000050110