UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037094 |
|---|---|
| Receipt number | R000042268 |
| Scientific Title | A proposal of crawling motion induction using visual effects in children with cerebral palsy |
| Date of disclosure of the study information | 2019/06/18 |
| Last modified on | 2019/06/18 00:20:51 |
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Basic information
Public title
A proposal of crawling motion induction using visual effects in children with cerebral palsy
Acronym
A proposal of crawling motion induction using visual effects in children with cerebral palsy
Scientific Title
A proposal of crawling motion induction using visual effects in children with cerebral palsy
Scientific Title:Acronym
A proposal of crawling motion induction using visual effects in children with cerebral palsy
Region
| Japan |
Condition
Condition
cerebral palsy
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A system in which physical behavior appears due to visual changes in the outside world is called "optical-flow", but this is the train on which you are riding due to the visual change in which the next train starts moving while you are on a stopped train It is a reaction that is recognized even in adults, such as having an illusion of having started moving and causing the posture to recover. This "optical flow" is already present in infancy regardless of the duration and presence of movement experience, and it has been reported that chewing motion appears by optical flow. In this study, we will create a space where you can experience optical flow, and use it for training children with cerebral palsy to examine its effects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The situation of the hand and foot when the image to be induced "Optical-flow" is flowing and when it is not flowing is photographed with video from above, side and front, and the image is analyzed by motion analysis software . Each evaluation time is about one minute, and the magnitude of movement is evaluated.
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
| Other |
Interventions/Control_1
By entering the equipment with a monitor installed on the front and side, and watching the image flowing from the monitor, it creates an illusion that oneself is moving and moves the limbs.The condition without stimulation and the condition through which the image flows are measured for 1 minute each, and it is measured 3 times.
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
| 3 | months-old | <= |
Age-upper limit
| 48 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy children who do not acquire crawling motion and children with cerebral palsy
Key exclusion criteria
Child who can not lift his head in prone position
Child who can not catch image visually
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | rina |
| Middle name | |
| Last name | hosoda |
Organization
Kochi University School of Medicine Hospital
Division name
Department of Rehabilitation
Zip code
783-8505
Address
Okocho Kohasu, Nankoku City, Kochi Prefecture
TEL
0888802490
jm-rina@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | rina |
| Middle name | |
| Last name | hosoda |
Organization
Kochi University School of Medicine Hospital
Division name
Department of Rehabilitation
Zip code
783-8505
Address
Okocho Kohasu, Nankoku City, Kochi Prefecture
TEL
0888802490
Homepage URL
jm-rina@kochi-u.ac.jp
Sponsor or person
Institute
Kochi University School of Medicine Hospital
Department of Rehabilitation
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
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
Kochi University School of Medicine Hospital Department of Rehabilitation
Address
Okocho Kohasu, Nankoku City, Kochi Prefecture
Tel
0888802490
jm-rina@kochi-u.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
| 2019 | Year | 06 | Month | 18 | 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
| 2019 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 06 | Month | 18 | Day |
Last modified on
| 2019 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042268
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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