UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of compression socks on changes in walking stability with age
Title of the study (Brief title)	Compression socks and walking stability
Region	Japan

Condition
Condition	walking stability
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Examining an effect of compression socks on changes in walking stability with age
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	age
Key secondary outcomes

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	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	without or with socks
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	70 years-old >=
Gender	Male and Female
Key inclusion criteria	- Mother tongue: Japanese - Healthy - Normal vision (including corrected-vision) - Ambulatory - Height: 150-175cm
Key exclusion criteria	subjects who do not satisfy the above conditions
Target sample size	240

Research contact person
Name of lead principal investigator	Ryuta Kawashima
Organization	Institute of Development, Aging and Cancer (IDAC), Tohoku University
Division name	Ubiquitous sensor
Address	4-1 Seiryocho, Aobaku, Sendai 980-8575, Japan
TEL	022-717-7988
Email	shigeyuki-i@idac.tohoku.ac.jp

Public contact
Name of contact person	Shigeyuki Ikeda
Organization	Institute of Development, Aging and Cancer (IDAC), Tohoku University
Division name	Ubiquitous sensor
Address	4-1 Seiryocho, Aobaku, Sendai 980-8575, Japan
TEL	022-717-7988
Homepage URL	http://www.idac.tohoku.ac.jp/kawashima_site_ja/
Email	shigeyuki-i@idac.tohoku.ac.jp

Sponsor
Institute	Institute of Development, Aging and Cancer (IDAC), Tohoku University
Institute
Department

Funding Source
Organization	company in Japan
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	加齢医学研究所

Other administrative information
Date of disclosure of the study information	2018 Year 02 Month 02 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2017 Year 12 Month 19 Day
Anticipated trial start date	2018 Year 02 Month 02 Day
Last follow-up date	2022 Year 03 Month 01 Day
Date of closure to data entry	2022 Year 03 Month 01 Day
Date trial data considered complete	2022 Year 03 Month 01 Day
Date analysis concluded	2022 Year 03 Month 01 Day

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 02 Month 01 Day
Last modified on	2019 Year 02 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035526