UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006492 |
|---|---|
| Receipt number | 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 05:31:17 |
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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 20–30 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
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
Sponsor or person
Institute
niigata university of health and welfare
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007703
