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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036608
Receipt No. R000041705
Scientific Title The effect of home-based vestibular rehabilitation in patients with peripheral vestibular disorder: a randomized controlled trial.
Date of disclosure of the study information 2019/05/14
Last modified on 2019/05/23

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Basic information
Public title The effect of home-based vestibular rehabilitation in patients with peripheral vestibular disorder: a randomized controlled trial.
Acronym The effect of home program in patients with peripheral vestibular disorder.
Scientific Title The effect of home-based vestibular rehabilitation in patients with peripheral vestibular disorder: a randomized controlled trial.
Scientific Title:Acronym The effect of home program in patients with peripheral vestibular disorder.
Region
Japan

Condition
Condition Peripheral vestibular disorder
Classification by specialty
Oto-rhino-laryngology Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the impact of home-based vestibular rehabilitation on physical function and physical activity in patients with peripheral vestibular disorder.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Functional Gait Assessment (FGA)

Key secondary outcomes Dynamic Gait Index (DGI)
Dizziness Handicap Iventory (DHI)
Physical activity
Stabilometry
EQ-5D-5L
Timed Up and Go Test (TUG)
Activities-Specific Balance Confidence (ABC)

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 YES
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom Maneuver
Interventions/Control_1 Standard treatment and Home-based vestibular rehabilitation for 4 weeks.
Interventions/Control_2 Standard treatment for 4 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 1. Patients diagnosed with peripheral vestibular disorder
2. Patients who is aware of balance dysfunction such as dizziness and feeling of floating for 3 months or more
3. Independent walking is possible
Key exclusion criteria 1. Symptom is unstable
2. Cognitive impairment
3. Not understand instruction
4. Benign Paroxysmal Positional Vertigo(BPPV)
5. Central dizziness
6. Patients taking medicines that cause vestibular dysfunction
7. Patients judged by physicians to be inappropriate for this study
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Ryozo
Middle name
Last name Tanaka
Organization Mejiro University
Division name Department of Physical Therapy, Faculty of Health Sciences
Zip code 3398501
Address 320 Ukiya, Iwatsukiku, Saitama-shi, Saitama, 339-8501, Japan
TEL 048-797-2131
Email r.tanaka@mejiro.ac.jp

Public contact
Name of contact person
1st name Ryozo
Middle name
Last name Tanaka
Organization Mejiro University
Division name Department of Physical Therapy, Faculty of Health Sciences
Zip code 3398501
Address 320 Ukiya, Iwatsukiku, Saitama-shi, Saitama, 339-8501, Japan
TEL 048-797-2131
Homepage URL
Email r.tanaka@mejiro.ac.jp

Sponsor
Institute Mejiro University Ear Institute Clinic, Otolaryngology
Institute
Department

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 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
Email 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 目白大学耳科研究所クリニック(埼玉県)
Mejiro University Ear Institute Clinic, Otolaryngology (saitama)

Other administrative information
Date of disclosure of the study information
2019 Year 05 Month 14 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
2019 Year 03 Month 18 Day
Date of IRB
2019 Year 03 Month 18 Day
Anticipated trial start date
2019 Year 05 Month 14 Day
Last follow-up date
2021 Year 07 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 04 Month 26 Day
Last modified on
2019 Year 05 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041705

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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