UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050448 |
|---|---|
| Receipt number | R000057456 |
| Scientific Title | Measurement of balance function by foot bathing with artificial carbonated warm water |
| Date of disclosure of the study information | 2023/02/28 |
| Last modified on | 2026/03/03 16:21:21 |
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Basic information
Public title
Measurement of balance function by foot bathing with artificial carbonated warm water
Acronym
Measurement of balance function by foot bathing with artificial carbonated warm water
Scientific Title
Measurement of balance function by foot bathing with artificial carbonated warm water
Scientific Title:Acronym
Measurement of balance function by foot bathing with artificial carbonated warm water
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
THe purpase of this study for the balance ability after artificial bicarboneted warm bathing
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Y balance test, area of one leg stance postural sway, and thumb extension angle value are used as indicators to measure changes in balance ability before and after carbonated warm water with foot bathing.
Key secondary outcomes
None.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
foot bathing with carbonated warm water(41degree Celsimius,15 minutes)
Interventions/Control_2
Foot bath with tap warm water
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 and Female
Key inclusion criteria
Healthy adults aged 20-30 who consented to participate in this study
Key exclusion criteria
People who fall under the contraindications of hyperthermia, and with balance problems due to orthopedic diseases, etc.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Masaharu |
| Middle name | |
| Last name | Maeda |
Organization
International University of health and welfare
Division name
Department of Rehabilitation
Zip code
324-8501
Address
2600-1 Kitakanamaru, Otawara City, Tochigi Prefecture
TEL
0287243016
mm@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | YUYAO |
| Middle name | |
| Last name | ZHANG |
Organization
International University of health and welfare
Division name
Department of Rehabilitation
Zip code
107-8402
Address
4-1-26 Akasaka, Minato-ku, Tokyo
TEL
07075958959
Homepage URL
narisu400@gmail.com
Sponsor or person
Institute
International University of health and welfare
Institute
Department
Personal name
Funding Source
Organization
International University of health and welfare
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
Clinical Trial Review Committee, International University of Health and Welfare
Address
4-1-26 Akasaka, Minato-ku, Tokyo
Tel
03-5574-3900
mm@iuhw.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 02 | Month | 28 | 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
24
Results
It was confirmed that warm carbonated water foot bathing using bath salts.The carbonated warm water foot bathing improved YBT and expanded the extension angle of the big toe. This suggests that the carbonated foot bathing improved the flexibility of the soft tissues of the feet, resulting in improved dynamic balance ability compared to the tap water foot bathing.
Results date posted
| 2026 | Year | 03 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 12 | Month | 06 | Day |
Baseline Characteristics
24 healthy adults
Participant flow
Adverse events
None
Outcome measures
Y balance test (YBT), center of gravity sway meter, and big toe extension angle
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 02 | Month | 28 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 03 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 02 | Month | 28 | Day |
Last modified on
| 2026 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057456
