UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037852 |
|---|---|
| Receipt number | R000042925 |
| Scientific Title | Influence of posture on functional evaluation of vestibulospinal tract using galvanic vestibular stimulation. |
| Date of disclosure of the study information | 2019/08/30 |
| Last modified on | 2019/08/30 00:02:06 |
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Basic information
Public title
Influence of posture on functional evaluation of vestibulospinal tract using galvanic vestibular stimulation.
Acronym
Influence of posture on the function of vestibulospinal tract.
Scientific Title
Influence of posture on functional evaluation of vestibulospinal tract using galvanic vestibular stimulation.
Scientific Title:Acronym
Influence of posture on the function of vestibulospinal tract.
Region
| Japan |
Condition
Condition
Healthy persons
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the influence of posture on the vestibulospinal tract function.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change ratio of the amplitude of soleus H reflex.
Key secondary outcomes
Amplitude of soleus H reflex.
Amplitude of M max.
Background EMG.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
1. Healthy adults
Key exclusion criteria
1. History of other neurological or vestibular disorders, severe orthopedic disease of lower limb and cardiovascular disease.
2. Presence of cardiac pacemaker.
3. History of epilepsy.
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | Okada |
| Middle name | |
| Last name | Yohei |
Organization
Kio University
Division name
Department of Physical Therapy, Faculty of Health Science.
Zip code
635-0832
Address
4-2-2 umami-naka koryo-cho, kitakatsuragi-gun, Nara, 635-0832 JAPAN.
TEL
+81-745-54-1601
y.okada@kio.ac.jp
Public contact
Name of contact person
| 1st name | Okada |
| Middle name | |
| Last name | Yohei |
Organization
Kio University
Division name
Department of Physical Therapy, Faculty of Health Science.
Zip code
635-0832
Address
4-2-2 umami-naka koryo-cho, kitakatsuragi-gun, Nara, 635-0832 JAPAN.
TEL
+81-745-54-1601
Homepage URL
y.okada@kio.ac.jp
Sponsor or person
Institute
Kio University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Kio University
Address
4-2-2 umami-naka koryo-cho, kitakatsuragi-gun, Nara, 635-0832 JAPAN.
Tel
+81-745-54-1601
y.okada@kio.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 08 | Month | 30 | 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
Preinitiation
Date of protocol fixation
| 2019 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design:Crossover design.
Recruitment method for subjects:Healty adults who have obtained consent for study.
Application period:Untill the end of study.
Management information
Registered date
| 2019 | Year | 08 | Month | 30 | Day |
Last modified on
| 2019 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042925
