UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023769 |
|---|---|
| Receipt number | R000027385 |
| Scientific Title | Evaluating how a walking assist suit using pneumatic artificial rubber muscles effects the gait of the wearer |
| Date of disclosure of the study information | 2016/09/01 |
| Last modified on | 2018/10/12 11:10:19 |
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Basic information
Public title
Evaluating how a walking assist suit using pneumatic artificial rubber muscles effects the gait of the wearer
Acronym
Evaluation of a walking assist suit
Scientific Title
Evaluating how a walking assist suit using pneumatic artificial rubber muscles effects the gait of the wearer
Scientific Title:Acronym
Evaluation of a walking assist suit
Region
| Japan |
Condition
Condition
Healthy people
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, a participant wears a walking assist suit driven by pneumatic artificial rubber muscles. The participant's gait is measured to evaluate the effects of the assist suit to the wearer's gait. The measured data may used for developing better control algorithm.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
The experiment evaluates how the wearer's gait, such as joint angle, is changed by the assist suit.
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
A participant wears the assist suit, while the assist control is active
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
Healthy people, who have no disability in walking
Key exclusion criteria
People who have disability in walking
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahiro Kanno |
Organization
Tokyo Medical and Dental University
Division name
Institute of Biomaterials and Bioengineering
Zip code
Address
2-3-10 Kanda-Surugadai, Chiyoda-ku, Tokyo
TEL
03-5280-8163
kanno.bmc@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahiro Kanno |
Organization
Tokyo Medical and Dental University
Division name
Institute of Biomaterials and Bioengineering
Zip code
Address
2-3-10 Kanda-Surugadai, Chiyoda-ku, Tokyo
TEL
03-5280-8163
Homepage URL
kanno.bmc@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
| 2016 | Year | 09 | Month | 01 | 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
| 2016 | Year | 08 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 25 | Day |
Last modified on
| 2018 | Year | 10 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027385
| 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 |
