UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048744 |
|---|---|
| Receipt number | R000055534 |
| Scientific Title | Relationship between one-leg standing and foot sole sensation after short term immobilization with the unilateral lower extremity |
| Date of disclosure of the study information | 2022/08/25 |
| Last modified on | 2022/08/24 17:16:10 |
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Basic information
Public title
Relationship between one-leg standing and foot sole sensation after short term immobilization with the unilateral lower extremity
Acronym
Relationship between one-leg standing and foot sole sensation after short term immobilization with the unilateral lower extremity
Scientific Title
Relationship between one-leg standing and foot sole sensation after short term immobilization with the unilateral lower extremity
Scientific Title:Acronym
Relationship between one-leg standing and foot sole sensation after short term immobilization with the unilateral lower extremity
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Several studies have suggested that inactivity for around 10 h can lead to decrease motor performance. In particular, it has been noted that the effects of lower limb inactivity may lead to decreased postural stability, and increased incidence of falls in the future. However, relationship between postural sway and related factors are not well understood. This study aimed to investigate the relationship between upright standing postural sway and foot sole sensitivity after short team of physical inactivity.
Basic objectives2
Others
Basic objectives -Others
Investigation of factors associated with decreased balance after cast immobilization
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Center of pressure and two-point discrimination test before and 10 h after immobilization.
Key secondary outcomes
Pain test,Psychological test
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
The participants could not move the immobilized unilateral lower limb for 10 h.
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
| 22 | years-old | >= |
Gender
Male
Key inclusion criteria
after informed consent is obtained, over 20 years old
Key exclusion criteria
the inability to give informed consent, under 20 years old
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takuro |
| Middle name | |
| Last name | Ikeda |
Organization
Fukuoka International University of Health and Welfare
Division name
Faculty of Medical Sciences
Zip code
814-0001
Address
3-6-40 Momochihama, Sawara-ku, Fukuoka
TEL
0928321200
ikeda@takagigakuen.ac.jp
Public contact
Name of contact person
| 1st name | Takuro |
| Middle name | |
| Last name | Ikeda |
Organization
Fukuoka International University of Health and Welfare
Division name
Faculty of Medical Sciences
Zip code
814-0001
Address
3-6-40 Momochihama, Sawara-ku, Fukuoka
TEL
0928321200
Homepage URL
ikeda@takagigakuen.ac.jp
Sponsor or person
Institute
Faculty of Medical Sciences, Fukuoka International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Fukuoka International University of Health and Welfare/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
Fukuoka International University of Health and Welfare
Address
3-6-40 Momochihama, Sawara-ku, Fukuoka
Tel
0928321200
ikeda@takagigakuen.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
| 2022 | Year | 08 | Month | 25 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/index.cgi?function=02
Publication of results
Unpublished
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-open-bin/ctr/index.cgi?function=02
Number of participants that the trial has enrolled
12
Results
Compared to before cast application, total and A-P trajectory length, mean velocity, RMS area increased and big toe sensitivity decreased after cast removal compared to before cast application, while there was no significant association between the factors.
Results date posted
| 2022 | Year | 08 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Twelve healthy male participants
Participant flow
Written informed consent was obtained from all participants.
Adverse events
None
Outcome measures
center of pressure
two-point discrimination test
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 06 | Month | 28 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 26 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 29 | Day |
Last follow-up date
| 2017 | Year | 09 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2022 | Year | 08 | Month | 08 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 08 | Month | 24 | Day |
Last modified on
| 2022 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055534
