UMIN-CTR Clinical Trial

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
Email	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
Email	y.okada@kio.ac.jp

Sponsor
Institute	Kio University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042925