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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040980
Receipt No. R000046785
Scientific Title Effects of plantar cutaneous and vestibular sensations on excitability of spinal motor neurons.
Date of disclosure of the study information 2020/07/05
Last modified on 2020/07/02

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Basic information
Public title Effects of plantar and vestibular sensations on excitability of spinal nerves.
Acronym Investigation of sensory information that affects the excitability of spinal nerves.
Scientific Title Effects of plantar cutaneous and vestibular sensations on excitability of spinal motor neurons.
Scientific Title:Acronym Effects of plantar cutaneous and vestibular sensations on excitability of spinal neurons.
Region
Japan

Condition
Condition adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the effects of plantar cutaneous and vestibular sensations on excitability of spinal motor neurons.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change of the amplitude of soleus H reflex by change posture and plantar cutanous stimulation.
Key secondary outcomes Amplitude of soleus H reflex.
Amplitude of M max.
Background electromyogram.

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
18 years-old <=
Age-upper limit
60 years-old >
Gender Male and Female
Key inclusion criteria Without person cardiovascular disease, nervous system disease, difficult to support weight, diseases affecting the autonomic nervous system.
Key exclusion criteria Person have cardiovascular disease, nervous system disease, difficult to support weight, diseases affecting the autonomic nervous system.
Target sample size 15

Research contact person
Name of lead principal investigator
1st name Yuta
Middle name
Last name Terasawa
Organization Kio University Graduate School
Division name Kio University Graduate School Neuro Rehabilitation research center
Zip code 6540832
Address 4-2-2 Umaminaka, Koryo-cho, Kitakatsuragi-gun, Nara Prefecture
TEL 09016491857
Email 16r0060@gmail.com

Public contact
Name of contact person
1st name Yuta
Middle name
Last name Terasawa
Organization Kio University Graduate School
Division name Kio University Graduate School Neuro Rehabilitation research center
Zip code 6540832
Address 4-2-2 Umaminaka, Koryo-cho, Kitakatsuragi-gun, Nara Prefecture
TEL 09016491857
Homepage URL
Email 16r0060@gmail.com

Sponsor
Institute Kio University Graduate School
Institute
Department

Funding Source
Organization Kio University Graduate School
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kio University Graduate School
Address 4-2-2 Umaminaka, Koryo-cho, Kitakatsuragi-gun, Nara Prefecture
Tel 09016491857
Email 16r0060@gmail.com

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
2020 Year 07 Month 05 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
2020 Year 06 Month 20 Day
Date of IRB
Anticipated trial start date
2020 Year 07 Month 05 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This in before the start of research, and there are no items to be described.

Management information
Registered date
2020 Year 07 Month 02 Day
Last modified on
2020 Year 07 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046785

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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