UMIN-CTR Clinical Trial

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
Email	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
Email	jm-rina@kochi-u.ac.jp

Sponsor
Institute	Kochi University School of Medicine Hospital Department of Rehabilitation
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042268