UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical trial to measure the blood flow velocity of lower limbs during the "partial weight-bearing treadmill walking" using air pressure
Title of the study (Brief title)	Clinical trial of the "partial weight-bearing treadmill walking"
Region	Japan

Condition
Condition	Healthy volunteers
Classification by specialty	Orthopedics Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to verify the change of the blood flow velocity of the lower limbs in the partial weight-bearing treadmill walking using the air pressure.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I

Assessment
Primary outcomes	blood flow velocity
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	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	#1; Standing at air pressure conditions and walking at air pressure conditions. #2; All of measurements of standing and walking will be completed within one hour.
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	#1; The researchers belong to the Faculty of Medicine. Therefore, participants are selected from among people who do not have the interest to the Faculty of Medicine and who apply voluntarily. #2; The participants have no pain in the knees #3; The participants are selected from students of Kyoto University.
Key exclusion criteria	#1; Persons who have heart disease and pulmonary disease are excluded. #2; Persons who have experienced loss of consciousness, respiratory arrest, hyperpnea, and cardiopulmonary arrest are excluded.
Target sample size	10

Research contact person
Name of lead principal investigator	Hiroshi Kuroki
Organization	Graduate School of Medicine, Kyoto University
Division name	Motor Function Analysis
Address	53 Kawahara-Cho, Shogoin, Sakyo-Ku, Kyoto 606-8507, JAPAN
TEL	+81-75-751-3963
Email	kuroki.hiroshi.6s@kyoto-u.ac.jp

Public contact
Name of contact person	Hiroshi Kuroki
Organization	Graduate School of Medicine, Kyoto University
Division name	Motor Function Analysis
Address	53 Kawahara-Cho, Shogoin, Sakyo-Ku, Kyoto 606-8507, JAPAN
TEL	+81-75-751-3963
Homepage URL
Email	kuroki.hiroshi.6s@kyoto-u.ac.jp

Sponsor
Institute	Motor Function Analysis, Graduate School of Medicine, Kyoto University
Institute
Department

Funding Source
Organization	Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Nationality of Funding Organization	JAPAN

Other related organizations
Co-sponsor	Gunze Limited
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	京都大学医学部附属病院（Kyoto University Hospital）

Other administrative information
Date of disclosure of the study information	2009 Year 08 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 07 Month 03 Day
Anticipated trial start date	2009 Year 09 Month 01 Day
Last follow-up date	2010 Year 09 Month 30 Day
Date of closure to data entry	2010 Year 09 Month 30 Day
Date trial data considered complete	2010 Year 09 Month 30 Day
Date analysis concluded	2010 Year 09 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2009 Year 08 Month 10 Day
Last modified on	2016 Year 08 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002531