UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002316 |
|---|---|
| Receipt number | 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 18:04:27 |
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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
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
kuroki.hiroshi.6s@kyoto-u.ac.jp
Sponsor or person
Institute
Motor Function Analysis, Graduate School of Medicine, Kyoto University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002531
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
