UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002129 |
|---|---|
| Receipt number | R000002601 |
| Scientific Title | Human locomotion on the moon simulated by a body suspension system |
| Date of disclosure of the study information | 2009/06/27 |
| Last modified on | 2009/12/28 08:39:26 |
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Basic information
Public title
Human locomotion on the moon simulated by a body suspension system
Acronym
Gait simulation for staying on the moon
Scientific Title
Human locomotion on the moon simulated by a body suspension system
Scientific Title:Acronym
Gait simulation for staying on the moon
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To propose the recommended gait pattern for human locomotion on the moon by using a cable suspension system to simulate reduced gravity
Basic objectives2
Others
Basic objectives -Others
Prevention of disuse syndrome while staying on the moon
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes of muscular activation patterns of a leg and trunk, step length, stance time, and cadence during walking under the body weight conditions of one sixth as well as one third
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
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Walking under the body weight conditions of one sixth as well as one third simulated by a cable suspension system
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
Key inclusion criteria
Healthy volunteers with the height <= 180 cm
Key exclusion criteria
1) Subjects with heart or lung disease influencing gait training.
2) Subjects with orthopedic disease influencing gait training.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kimitaka Hase |
Organization
Keio University School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
Address
Shinano-machi 35, Shinjuku-ku, Tokyo, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kimitaka Hase |
Organization
Keio University School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
Address
Shinano-machi 35, Shinjuku-ku, Tokyo, Japan.
TEL
03-3353-1211
Homepage URL
khase@sc.itc.keio.ac.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Aerospace Exploration Agency
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
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
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 06 | Month | 27 | 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 | 06 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2010 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 06 | Month | 27 | Day |
Last modified on
| 2009 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002601
| 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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