UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044251 |
|---|---|
| Receipt number | 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 | 2022/12/19 14:44:19 |
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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
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
mgocho@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare, Department of Occupational Therapy, Faculty of Health Science in Odawara
Institute
Department
Personal name
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
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
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 05 | Month | 19 | Day |
Last modified on
| 2022 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050533
