UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031178 |
|---|---|
| Receipt number | R000035594 |
| Scientific Title | The effects of artificial carbon dioxide foot-bathing on Cardio-Ankle Vascular Index and walking speed |
| Date of disclosure of the study information | 2018/02/06 |
| Last modified on | 2018/08/08 10:18:26 |
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Basic information
Public title
The effects of artificial carbon dioxide foot-bathing on Cardio-Ankle Vascular Index and walking speed
Acronym
The effect of artificial carbon dioxide foot-bathing on CAVI
Scientific Title
The effects of artificial carbon dioxide foot-bathing on Cardio-Ankle Vascular Index and walking speed
Scientific Title:Acronym
The effect of artificial carbon dioxide foot-bathing on CAVI
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate artificial carbon dioxide foot-bathing on Cardio-Ankle Vascular Index and walking speed by using a randomized controlled design
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
CAVI (baseline and after 4weeks intervention)
Key secondary outcomes
Walking speed, passive ankle dorsiflexion, plantar pressure distribution and systolic blood pressure (baseline and after 4weeks)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Interventions
Artificial carbon dioxide foot-bathing two times per week for the next four weeks
Interventions/Control_2
Control
No treatment
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
| 60 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy adult who made a declaration of participation in this study with written consent.
Healthy adult who can ambulate without walking-aides.
Key exclusion criteria
Pain in plantar and/or nail
Peripheral artery diseases
Immediate after minor amputation and/or undergoing wound treatment
Past history of ankle arthrodesis joint contracture
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hisae Hayashi |
Organization
Seijoh University
Division name
Faculty of Rehabilitation and Care
Zip code
Address
2-172, Fukinodai, Tokai City, Aichi Prefecture, Japan
TEL
052-601-6000
hisaehayashi@seijoh-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hisae Hayashi |
Organization
Seijoh University
Division name
Faculty of Rehabilitation and Care
Zip code
Address
2-172, Fukinodai, Tokai City, Aichi Prefecture, Japan
TEL
052-601-6000
Homepage URL
hisaehayashi@seijoh-u.ac.jp
Sponsor or person
Institute
Seijoh University
Institute
Department
Personal name
Funding Source
Organization
Seijoh-university
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
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
星城大学（愛知県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | 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
| 2017 | Year | 09 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 09 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 06 | Day |
Last modified on
| 2018 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035594
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
