UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057736 |
|---|---|
| Receipt number | R000065966 |
| Scientific Title | An observational study evaluating the safety and efficacy of virtual reality-integrated somato-cognitive coordination therapy in pediatric and adolescent and young adult patients across a range of medical conditions |
| Date of disclosure of the study information | 2025/04/29 |
| Last modified on | 2025/05/18 15:58:55 |
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Basic information
Public title
An observational study evaluating the safety and efficacy of virtual reality-integrated somato-cognitive coordination therapy in pediatric and adolescent and young adult patients across a range of medical conditions
Acronym
VISION study : Virtual reality-Integrated Somato-cognitive coordinatION therapy in pediatric and adolescent and young adult(AYA) patients
Scientific Title
An observational study evaluating the safety and efficacy of virtual reality-integrated somato-cognitive coordination therapy in pediatric and adolescent and young adult patients across a range of medical conditions
Scientific Title:Acronym
VISION study: Virtual reality-Integrated Somato-cognitive coordinatION therapy in pediatric and adolescent and young adult(AYA) patients
Region
| Japan |
Condition
Condition
Patients under 40 years of age in the pediatric and AYA (Adolescent and Young Adult) populations presenting with physical or cognitive abnormalities.
Classification by specialty
| Pediatrics | Psychiatry | Orthopedics |
| Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness and safety of somato-cognitive coordination therapy (SCCT) using virtual reality (VR) devices in pediatric and adolescent and young adult (AYA) patients with various diseases and symptoms.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety Assessment
Adverse events during SCCT, including VR sickness, falls, and CTCAE Grade 3 or higher events.
Possible efficacy such as therapeutic signals defined by the association between sysmptom improvement and intervention
Key secondary outcomes
Efficacy Assessment
Changes in physical function at 1, 3, and 6 months after treatment initiation, or at the final follow-up.
Changes in cognitive function at 1, 3, and 6 months after treatment initiation, or at the final follow-up.
Changes in imaging findings at 1, 3, and 6 months after treatment initiation, or at the final follow-up.
Changes in physiological function test results at 1, 3, and 6 months after treatment initiation, or at the final follow-up.
Changes in Quality of Life (QOL) scores at 1, 3, and 6 months after treatment initiation, or at the final follow-up.
Changes in outcome measures identified by the investigator as necessary at 1, 3, and 6 months after treatment initiation, or at the final follow-up.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 | months-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients under 40 years of age in the pediatric and AYA (Adolescent and Young Adult) populations presenting with physical or cognitive abnormalities.
Key exclusion criteria
1) Patients deemed inappropriate for participation by the principal investigator or co-investigators.
2) Patients who did not provide written informed consent.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masanobu |
| Middle name | |
| Last name | Takeuchi |
Organization
Yokohama City University Hospital
Division name
Pediatrics
Zip code
236-0004
Address
Fukuura 3-9, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL
045-787-2800
mtake@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Masanobu |
| Middle name | |
| Last name | Takeuchi |
Organization
Yokohama City University Hospital
Division name
Pediatrics
Zip code
236-0004
Address
Fukuura 3-9, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL
045-787-2800
Homepage URL
mtake@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Hospital
Institute
Department
Personal name
Funding Source
Organization
Certified NPO Heart Link Working Project
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama City University, Ethics Committee for Medical Research Involving Human Participants
Address
Fukuura 3-9, Kanazawa-ku, Yokohama, Kanagawa, Japan
Tel
0453707627
rinri@yokohama-cu.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
| 2025 | Year | 04 | Month | 29 | 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 | 02 | Month | 27 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 17 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 29 | 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
Background Information
Clinical Findings
Physical Function Assessment Indicators
Cognitive Function Disorder Assessment Tests
Blood Test Results
Imaging Test Results
Physiological Test Results
Pathological Findings
Questionnaire
Management information
Registered date
| 2025 | Year | 04 | Month | 29 | Day |
Last modified on
| 2025 | Year | 05 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065966
