UMIN-CTR Clinical Trial

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
Email	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
Email	ikeda@takagigakuen.ac.jp

Sponsor
Institute	Faculty of Medical Sciences, Fukuoka International University of Health and Welfare
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055534