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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006492
Receipt No. R000007703
Scientific Title The effect of water immersion on short-latency somatosensory evoked potentials in human
Date of disclosure of the study information 2011/10/06
Last modified on 2012/01/20

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Basic information
Public title The effect of water immersion on short-latency somatosensory evoked potentials in human
Acronym Somatosensory evoked potentials in water immersion
Scientific Title The effect of water immersion on short-latency somatosensory evoked potentials in human
Scientific Title:Acronym Somatosensory evoked potentials in water immersion
Region
Japan

Condition
Condition stroke
Classification by specialty
Rehabilitation medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to examine the effect of water immersion on the short-latency SEPs in response to median nerve stimuli
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes Short-latency evoked potentials
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Device,equipment Behavior,custom
Interventions/Control_1 Water immersed condition
Interventions/Control_2 Non-immersed condition
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
20 years-old <
Age-upper limit
30 years-old >
Gender Male
Key inclusion criteria healthy male volunteers aged 20&#8211;30 y, right-handed, gave their informed consent
Key exclusion criteria a history of neurological or psychiatric disease, any medications
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name daisuke sato
Organization niigata university of health and welfare
Division name Institute for human movement and medical sciences
Zip code
Address 1398Shimami- cho 1398, kita-ku, Niigata city, Japan
TEL 025-257-4624
Email

Public contact
Name of contact person
1st name
Middle name
Last name daisuke sato
Organization niigata university of health and welfare
Division name Institute for human movement and medical sciences
Zip code
Address Shimami- cho 1398, kita-ku, Niigata city, Japan
TEL 025-257-4624
Homepage URL
Email

Sponsor
Institute niigata university of health and welfare
Institute
Department

Funding Source
Organization the Ministry of Education, Culture, Sports, Science and Technology (MEXT) of Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s) Niigata University of Health and Welfare

IRB Contact (For public release)
Organization
Address
Tel
Email

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 新潟医療福祉大学(新潟県)

Other administrative information
Date of disclosure of the study information
2011 Year 10 Month 06 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
2011 Year 08 Month 31 Day
Date of IRB
Anticipated trial start date
2011 Year 11 Month 01 Day
Last follow-up date
2011 Year 12 Month 01 Day
Date of closure to data entry
2011 Year 12 Month 01 Day
Date trial data considered complete
2012 Year 01 Month 01 Day
Date analysis concluded
2012 Year 01 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 10 Month 06 Day
Last modified on
2012 Year 01 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007703

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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