UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039876 |
|---|---|
| Receipt number | R000045474 |
| Scientific Title | The training of the foot-toe. The effecs of the continuous training. |
| Date of disclosure of the study information | 2020/03/19 |
| Last modified on | 2023/09/21 10:44:47 |
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Basic information
Public title
The training of the foot-toe. The effecs of the continuous training.
Acronym
The training of the foot-toe.
Scientific Title
The training of the foot-toe. The effecs of the continuous training.
Scientific Title:Acronym
The training of the foot-toe.
Region
| Japan |
Condition
Condition
normal volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To discuss the easy-training for the strength of the foot toe.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
To measure the pinch test of the foot-toe after training for the every week until 3 weeks.
Key secondary outcomes
To measure the grip, and ten-secomd test of the foot-toe after training for the every week until 3 weeks.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
foot-toe exercize (every day for 3 weeks)
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Normal volunteers who agreed with the participation of the clinical research after the enough explanation.
Key exclusion criteria
1)not agreed with the participation of the clinical research.
2)persons who has trouble or disturbance of the leg, foot, or toes.
3)persons who has trouble to keep standing or gait.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Masahiko |
| Middle name | |
| Last name | Kanamori |
Organization
University of Toyama
Division name
Human science 1, Academic assembly (Faculty of Medicine)
Zip code
930-0194
Address
2630 Sugitani, Toyama, JAPAN
TEL
076-434-7405
kanamori@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Masahiko |
| Middle name | |
| Last name | Kanamori |
Organization
University of Toyama
Division name
Human science 1, Academic assembly (Faculty of Medicine)
Zip code
930-0194
Address
2630 Sugitani, Toyama city, Toyama, 930-0194 JAPAN
TEL
076-434-7405
Homepage URL
kanamori@med.u-toyama.ac.jp
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
Masahiko Kanamori
Funding Source
Organization
University of Toyama
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Center for Cinical Rsearch
Address
2630 Sugitani, Toyama, JAPAN
Tel
076-434-7664
yuka@adm.u-toyama.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
富山大学杉谷キャンパス 看護学科研究棟4階（富山県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | Month | 19 | 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
15
Results
The data were not collected because of the pandemic of COVID-19.
Results date posted
| 2023 | Year | 09 | Month | 21 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
The data were not collected because of the pandemic of COVID-19.
Date of the first journal publication of results
Baseline Characteristics
community-dwelling people
Participant flow
The data were not collected because of the pandemic of COVID-19.
Adverse events
none
Outcome measures
Plan to share IPD
none
IPD sharing Plan description
none
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2018 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 03 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 03 | Day |
Last follow-up date
| 2021 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 03 | Month | 19 | Day |
Last modified on
| 2023 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045474
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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