UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055880 |
|---|---|
| Receipt number | R000063454 |
| Scientific Title | Effects of vestibular rehabilitation for patients with persistent postural-perceptual dizziness: A randomized controlled study |
| Date of disclosure of the study information | 2024/10/18 |
| Last modified on | 2024/10/18 18:21:54 |
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Basic information
Public title
Effects of vestibular rehabilitation for patients with persistent postural-perceptual dizziness: A randomized controlled study
Acronym
Effects of vestibular rehabilitation for patients with PPPD
Scientific Title
Effects of vestibular rehabilitation for patients with persistent postural-perceptual dizziness: A randomized controlled study
Scientific Title:Acronym
Effects of vestibular rehabilitation for patients with PPPD
Region
| Japan |
Condition
Condition
Persistent Postural-Perceptual Dizziness
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the effects of vestibular rehabilitation in patients with persistent postural-perceptual dizziness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Dizziness Handicap Inventory (DHI)
Key secondary outcomes
Visual vertigo analogue scale (VVAS)
Functional gait assessment (FGA)
Dynamic gait index (DGI)
Balance Error Scoring System (BESS)
Dynamic Visual Acuity (DVA)
Stabilometry
Activities-specific balance confidence (ABC) scale
Niigata PPPD questionnaire (NPQ)
Hospital anxiety and depression scale (HADS)
Dizziness catastrophizing Scale (DCS)
Central Sensitization Inventory (CSI)
Vestibular Activities Avoidance Instrument (VAAI)
Pittsburgh sleep quality index (PSQI)
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
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Vestibular rehabilitation
Intervention period: 6 weeks
Interventions/Control_2
Usual treatment
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients with persistent postural-perceptual dizziness
2. Total score of 31 or more on the Dizziness Handicap Inventory (DHI)
Key exclusion criteria
1. Patients who have previously undergone vestibular rehabilitation
2. Cognitive impairment
3. Central neurological symptoms
4. Patients taking SSRI or SNRI in the last month
Target sample size
30
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
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
Medical Research Ethics Committee of Mejiro University
Address
320 Ukiya, Iwatsuki-ku, Saitama-shi, Saitama
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
目白大学耳科学研究所クリニック(埼玉県)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | Month | 18 | 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
| 2024 | Year | 10 | Month | 18 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 08 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 18 | Day |
Last follow-up date
| 2027 | Year | 11 | 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
| 2024 | Year | 10 | Month | 18 | Day |
Last modified on
| 2024 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063454
