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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000044251
Receipt No. R000050533
Scientific Title Study on the effects of posture improvement program using VR for children with developmental disabilities in the lower grades of elementary school -Preliminary research-
Date of disclosure of the study information 2021/05/19
Last modified on 2021/10/21

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Basic information
Public title Study on the effects of posture improvement program using VR for children with developmental disabilities in the lower grades of elementary school -Preliminary research-
Acronym Study on the effects of posture improvement program using VR for children with developmental disabilities in the lower grades of elementary school -Preliminary research-
Scientific Title Study on the effects of posture improvement program using VR for children with developmental disabilities in the lower grades of elementary school -Preliminary research-
Scientific Title:Acronym Study on the effects of posture improvement program using VR for children with developmental disabilities in the lower grades of elementary school -Preliminary research-
Region
Japan

Condition
Condition Developmental disability
Classification by specialty
Pediatrics Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to examine a posture improvement program using VR for children in the lower grades of elementary school with developmental disabilities.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Perform the one-leg standing test 4 weeks before the intervention, before the first intervention, and after the intervention.
Key secondary outcomes Time required, Number of successes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 The intervention is a program using VR. Children sit on a balance ball and touch the object projected on the wall. The period is twice a week for 4 weeks.
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
6 years-old <=
Age-upper limit
8 years-old >
Gender Male and Female
Key inclusion criteria 1) First grade of elementary school.
2) Children using the Child Development Support Center.
3) Children with autism spectrum disorders and Attention deficit hyperactivity disorder, Learning disabilities, etc.
Key exclusion criteria 1) Children with moderate or higher intellectual disabilities
2) Children who do not understand the program description
3) Children with movement disorders
4) Children with visual impairment
Target sample size 35

Research contact person
Name of lead principal investigator
1st name Masatoshi
Middle name
Last name Gocho
Organization International University of Health and Welfare
Division name Department of Occupational Therapy, Faculty of Health Science in Odawara
Zip code 250-8588
Address 1-2-25, Shiroyama, Odawara city, Kanagawa
TEL 0465-21-0361
Email mgocho@iuhw.ac.jp

Public contact
Name of contact person
1st name Masatoshi
Middle name
Last name Gocho
Organization International University of Health and Welfare
Division name Department of Occupational Therapy, Faculty of Health Science in Odawara
Zip code 250-8588
Address 1-2-25, Shiroyama, Odawara city, Kanagawa
TEL 0465-21-0361
Homepage URL
Email mgocho@iuhw.ac.jp

Sponsor
Institute International University of Health and Welfare, Department of Occupational Therapy, Faculty of Health Science in Odawara
Institute
Department

Funding Source
Organization Self funding
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 International University of Health and Welfare
Address 1-2-25, Shiroyama, Odawara city, Kanagawa
Tel 0465-21-0361
Email mgocho@iuhw.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
2021 Year 05 Month 19 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 Enrolling by invitation
Date of protocol fixation
2021 Year 05 Month 18 Day
Date of IRB
2021 Year 06 Month 04 Day
Anticipated trial start date
2021 Year 06 Month 07 Day
Last follow-up date
2023 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
2021 Year 05 Month 19 Day
Last modified on
2021 Year 10 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050533

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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