UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040980 |
|---|---|
| Receipt number | 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 13:12:17 |
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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
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
16r0060@gmail.com
Sponsor or person
Institute
Kio University Graduate School
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046785
