UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049481 |
|---|---|
| Receipt number | R000056346 |
| Scientific Title | The impact of whole-hand water flow stimulation on motor learning and neural plasticity in the primary motor cortex |
| Date of disclosure of the study information | 2022/11/13 |
| Last modified on | 2024/05/31 08:03:19 |
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Basic information
Public title
Effects of water flow stimulation on motor learning and related neural activity
Acronym
Effect of water flow stimulation on motor learning
Scientific Title
The impact of whole-hand water flow stimulation on motor learning and neural plasticity in the primary motor cortex
Scientific Title:Acronym
Effect of water flow stimulation on motor learning
Region
| Japan |
Condition
Condition
Healthy persons
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The present study aims to examine the impact of whole-hand water stimulation on motor learning and neural plasticity in the primary motor cortex.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The performance of the visual tracking task is measured before and after each intervention on the first day and 24 hours after.
Key secondary outcomes
The excitability of the primary motor cortex is evaluated before and after each intervention and after motor learning.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
One trial for whole-hand water flow stimulation in 30 min
Interventions/Control_2
One trial for Whole-hand water immersion in 30 min
Interventions/Control_3
One trial for Non-immersed control in 30 min
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
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Persons who have an interest in the present study and who voluntarily volunteer to participate in the present study in the response to recruitment.
Key exclusion criteria
Persons who have no morbidity and history of neurological, psychological or mental diseases
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Sato |
Organization
Niigata University of Health and Welfare
Division name
Department of Health and Sports
Zip code
950-3198
Address
1398, Shimami-cho, Kita-ku, Niigata city, Niigata
TEL
025-257-4624
daisuke@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Sato |
Organization
Niigata University of Health and Welfare
Division name
Department of Health and Sports
Zip code
950-3198
Address
1398, Shimami-cho, Kita-ku, Niigata city, Niigata
TEL
025-257-4624
Homepage URL
daisuke@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata University of Health and Welfare
Address
1398, Shimami-cho, Kita-ku, Niigata city, Niigata
Tel
025-257-4624
daisuke@nuhw.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
新潟医療福祉大学（新潟県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 11 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
19
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
| 2022 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 07 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 01 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 11 | Month | 12 | Day |
Last modified on
| 2024 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056346
