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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name