UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055498 |
|---|---|
| Receipt number | R000063415 |
| Scientific Title | Effects of sensor games on children with severe mental and physical disorders: Feasibility study |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2025/04/24 07:37:50 |
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Basic information
Public title
Effects of sensor games on children with severe mental and physical disorders: Feasibility study
Acronym
Effects of sensor games on children with severe mental and physical disorders
Scientific Title
Effects of sensor games on children with severe mental and physical disorders: Feasibility study
Scientific Title:Acronym
Effects of sensor games on children with severe mental and physical disorders
Region
| Japan |
Condition
Condition
children with severe mental and physical disorders
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effects of sensor games on children with severe mental and physical disorders
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
CHOP INTEND, KIDSCREEN, Parenting Stress Index, Burnout Assessment Tool
Key secondary outcomes
Gross Motor Function Classification System
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
Treatment
Type of intervention
| Other |
Interventions/Control_1
Sensor games
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
| 1 | days-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Determination of children with severe mental and physical disorders
Key exclusion criteria
Determination of brain death
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Annaka |
Organization
Niigata university of health and welfare
Division name
Department of Occupational Therapy
Zip code
9503198
Address
1398, Shimami-cho, Kita-ku, Niigata
TEL
025-257-4455
hiroki-annaka@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Annaka |
Organization
Niigata University of Health and Welfare
Division name
Department of Occupational Therapy
Zip code
9503198
Address
1398, Shimami-cho, Kita-ku, Niigata
TEL
025-257-4455
Homepage URL
hiroki-annaka@nuhw.ac.jp
Sponsor or person
Institute
Niigata university of health and welfare
Institute
Department
Personal name
Funding Source
Organization
none
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
Niigata University Health and Welfare
Address
1398 Shimami-chou, Kita-ku, Niigata
Tel
025-257-4455
rinri@nuhw.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
none
Org. issuing International ID_1
none
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 30 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | 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
| 2024 | Year | 09 | Month | 13 | Day |
Last modified on
| 2025 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063415
