UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036608 |
|---|---|
| Receipt number | 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 | 2023/04/29 16:59:58 |
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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
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
r.tanaka@mejiro.ac.jp
Sponsor or person
Institute
Mejiro University Ear Institute Clinic, Otolaryngology
Institute
Department
Personal name
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
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
https://doi.org/10.2490/prm.20230002
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.2490/prm.20230002
Number of participants that the trial has enrolled
42
Results
The home-based vestibular rehabilitation program in this study was effective in improving gait function and dizziness in patients with chronic peripheral vestibular hypofunction.
Results date posted
| 2023 | Year | 04 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with chronic peripheral vestibular hypofunction.
Participant flow
Participants were randomly divided into the vestibular rehabilitation group or the control group. Participants in the vestibular rehabilitation group received a supervised home-based vestibular rehabilitation program using a booklet in addition to physician care for 4 weeks.The control group received physician care only during the 4-week trial period.
Adverse events
None
Outcome measures
Functional Gait Assessment (FGA)
Dynamic Gait Index (DGI)
Dizziness Handicap Inventory (DHI)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2022 | Year | 09 | Month | 20 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 04 | Month | 26 | Day |
Last modified on
| 2023 | Year | 04 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041705
