UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033315 |
|---|---|
| Receipt number | R000037976 |
| Scientific Title | Performance Evaluation Experiments of Gait Assistive Suit Using Pneumatic Artificial Rubber Muscle |
| Date of disclosure of the study information | 2018/07/06 |
| Last modified on | 2020/07/07 10:24:38 |
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Basic information
Public title
Performance Evaluation Experiments of Gait Assistive Suit Using Pneumatic Artificial Rubber Muscle
Acronym
Performance Evaluation of Gait Assistive Suit
Scientific Title
Performance Evaluation Experiments of Gait Assistive Suit Using Pneumatic Artificial Rubber Muscle
Scientific Title:Acronym
Performance Evaluation of Gait Assistive Suit
Region
| Japan |
Condition
Condition
Gait training on a treadmill
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Performance evaluation of the proposed gait assistive suit
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measuring leg EMGs (calf, thigh, total of 4 to 8 channels)
Key secondary outcomes
Measuring leg motion trajectories measured by a motion capture system
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
The external force generated by the gait assistive suit
The using time is about 1 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
| 60 | years-old | >= |
Gender
Male
Key inclusion criteria
Because the assistant (male) may contact the body of the subject (support for falling prevention, set the electrode for myoelectric measurement etc.), research subjects are limited to 20 to 60 years old healthy male who can walk on their own.
Key exclusion criteria
Those who have hurdles to walking are excluded.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Tetsuro |
| Middle name | |
| Last name | Miyazaki |
Organization
Tokyo Medical and Dental University
Division name
Institute of Biomaterials and Bioengineering
Zip code
1010062
Address
2-3-10 Kanda Surugadai, Chiyoda-ku, Tokyo
TEL
0352808163
tmiyazaki.bmc@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Institute of Biomaterials and Bioengineering |
| Middle name | |
| Last name | General affairs section |
Organization
Tokyo Medical and Dental University
Division name
Institute of Biomaterials and Bioengineering
Zip code
1010062
Address
2-3-10 Kanda Surugadai, Chiyoda-ku, Tokyo
TEL
0352808003
Homepage URL
zaikensoumu.adm@cmn.tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Bridgestone Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical and Dental University
Address
2-3-10 Kanda Surugadai, Chiyoda-ku
Tel
0352808003
zaikensoumu.adm@tmd.ac.jp
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
| 2018 | Year | 07 | Month | 06 | 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
5
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
| 2018 | Year | 07 | Month | 06 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 28 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 07 | Month | 06 | Day |
Last modified on
| 2020 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037976
