UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026398 |
|---|---|
| Receipt number | R000030330 |
| Scientific Title | Development of the device which generate voluntary movement to verify brain function |
| Date of disclosure of the study information | 2017/03/06 |
| Last modified on | 2017/03/04 15:53:06 |
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Basic information
Public title
Development of the device which generate voluntary movement to verify brain function
Acronym
Development of the device which generate voluntary movement to verify brain function
Scientific Title
Development of the device which generate voluntary movement to verify brain function
Scientific Title:Acronym
Development of the device which generate voluntary movement to verify brain function
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of reproducibility of walking in lower limb exercise using device
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Motion capture
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
The subjects carries out the three tasks shown below in clinical trial once.
The task is carried out in order.
1.After resting for 3 seconds, walking normally for 10 steps.
2.Attaching the device to the foot, moving the lower limbs symmetrically for 10 steps after resting for 3 seconds.
3.Attaching the device to the foot, moving the lower limbs symmetrically for 10 steps with one leg supported by passive support, moving the other foot only after resting for 3 seconds.
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
| 23 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy adults
Key exclusion criteria
1.It is difficult to walk normally
2.There are obstacles affecting movement of lower limbs
3.Pain and injury in each joint / muscle of the foot
4.There is inflammation in the attached part of the device
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyasu Iwata |
Organization
Waseda university
Division name
Faculty science and engineering
Zip code
Address
27 Waseda-cyo, Shinjuku-ku, Tokyo 162-0044, Japan Green Computing Systems Reserch Organization 603 Prof. Iwata Lab.
TEL
03-3203-4427
jubi@waseda.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyasu Iwata |
Organization
Waseda university
Division name
Faculty science and engineering
Zip code
Address
27 Waseda-cyo, Shinjuku-ku, Tokyo 162-0044, Japan Green Computing Systems Reserch Organization 603 P
TEL
03-3203-4427
Homepage URL
jubi@waseda.jp
Sponsor or person
Institute
Waseda university
Institute
Department
Personal name
Funding Source
Organization
Waseda University
Organization
Division
Category of Funding Organization
Other
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
| 2017 | Year | 03 | 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
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
Preinitiation
Date of protocol fixation
| 2016 | Year | 11 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 03 | Month | 06 | 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
| 2017 | Year | 03 | Month | 04 | Day |
Last modified on
| 2017 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030330
