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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002316
Receipt No. R000002531
Scientific Title Clinical trial to measure the blood flow velocity of lower limbs during the "partial weight-bearing treadmill walking" using air pressure
Date of disclosure of the study information 2009/08/10
Last modified on 2016/08/15

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Basic information
Public title Clinical trial to measure the blood flow velocity of lower limbs during the "partial weight-bearing treadmill walking" using air pressure
Acronym Clinical trial of the "partial weight-bearing treadmill walking"
Scientific Title Clinical trial to measure the blood flow velocity of lower limbs during the "partial weight-bearing treadmill walking" using air pressure
Scientific Title:Acronym 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
1st name
Middle name
Last name Hiroshi Kuroki
Organization Graduate School of Medicine, Kyoto University
Division name Motor Function Analysis
Zip code
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
1st name
Middle name
Last name Hiroshi Kuroki
Organization Graduate School of Medicine, Kyoto University
Division name Motor Function Analysis
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2009 Year 07 Month 03 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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