UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018804 |
|---|---|
| Receipt number | R000021756 |
| Scientific Title | Home physical therapy in outpatients with benign paroxysmal positional vertigo |
| Date of disclosure of the study information | 2015/09/01 |
| Last modified on | 2023/09/01 14:29:30 |
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Basic information
Public title
Home physical therapy in outpatients with benign paroxysmal positional vertigo
Acronym
Home physical therapy for BPPV
Scientific Title
Home physical therapy in outpatients with benign paroxysmal positional vertigo
Scientific Title:Acronym
Home physical therapy for BPPV
Region
| Japan |
Condition
Condition
Patients with benign paroxysmal positional vertigo
Classification by specialty
| Neurology | Oto-rhino-laryngology | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of home physical therapy for benign paroxysmal positional vertigo.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Vertigo and/or dizziness, and nystagmus at the time after 1 week.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Clinic physical therapy + 1-week home physical therapy Group:
Posterior semicircular type: Epley maneuver in clinic followed by Semont maneuver in home (1 week).
Lateral semicircular canal type:
Lempert maneuver in clinic followed by Vannucchi maneuver in home (1 week).
Interventions/Control_2
Clinic physical therapy Group:
Posterior semicircular type: Epley maneuver in clinic.
Lateral semicircular canal type:
Lempert maneuver in clinic.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with benign paroxysmal positional vertigo.
Key exclusion criteria
Patients with contraindication of physical therapy.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ken Johkura |
Organization
Yokohama Brain and Spine Center
Division name
Department of Neurology
Zip code
Address
1-2-1 Takigashira, Isogo-ku, Yokohama 235-0012, Japan
TEL
045-753-2500
ke00-johkura@city.yokohama.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ken Johkura |
Organization
Yokohama Brain and Spine Center
Division name
Department of Neurology
Zip code
Address
1-2-1 Takigashira, Isogo-ku, Yokohama 235-0012, Japan
TEL
045-753-2500
Homepage URL
ke00-johkura@city.yokohama.jp
Sponsor or person
Institute
Yokohama Brain and Spine Center
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
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 09 | 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
Completed
Date of protocol fixation
| 2014 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 03 | Month | 19 | Day |
Anticipated trial start date
| 2014 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 08 | Month | 26 | Day |
Last modified on
| 2023 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021756
