UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056624 |
|---|---|
| Receipt number | R000064717 |
| Scientific Title | Multicenter observational study using medical records and cloud databases on somato-cognitive coordination therapy using virtual reality (VR) technology |
| Date of disclosure of the study information | 2025/01/04 |
| Last modified on | 2025/01/08 21:50:48 |
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Basic information
Public title
Multicenter observational study using medical records and cloud databases on somato-cognitive coordination therapy using virtual reality (VR) technology
Acronym
RECOVER RECORD Trial (REprogramming COordination through Virtual Environment Rehabilitation: Real-world Evidence from Clinical Observations and RecorDs trial)
Scientific Title
Multicenter observational study using medical records and cloud databases on somato-cognitive coordination therapy using virtual reality (VR) technology
Scientific Title:Acronym
RECOVER RECORD Trial
Region
| Japan | Asia(except Japan) |
Condition
Condition
All people who have received an evaluation and intervention using somato-cognitive coordination therapy (SCCT), regardless of whether they have a physical or cognitive impairment, and whose data has been saved in the medical record database or mediVR KAGURA system.
Classification by specialty
| Cardiology | Neurology | Pediatrics |
| Orthopedics | Neurosurgery | Rehabilitation medicine |
| Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate and estimate the safety, epidemiological data, and treatment effects of somato-cognitive coordination therapy (SCCT) using virtual reality (VR) technology for various diseases, symptoms using all existing epidemiological and real world data such as medical records and other mediVR KAGURA system cloud data.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical indices (physical function and cognitive function assessments) before and after SCCT, safety information such as side effect information, other disease-specific tests, blood data (biomarkers), and other findings deemed necessary by researchers
Key secondary outcomes
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 | years-old | <= |
Age-upper limit
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
All people who have received an evaluation and intervention using SCCT, regardless of whether they have a physical or cognitive impairment, and whose data has been saved in the medical record database or mediVR KAGURA system.
Key exclusion criteria
1) Those who are judged by the principal investigator or sub-investigator to be unsuitable for participation in the study
2) Those who have expressed their intention to refuse participation in this study through the opt-out system
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Masahiko |
| Middle name | |
| Last name | Hara |
Organization
mediVR, Inc.
Division name
Department of Neurology and Clinical Rehabilitation, mediVR Rehabilitation Center
Zip code
561-0872
Address
4-1, 2-chome, Teranai, Toyonaka City, Osaka Prefecture, 3rd Floor, Ryokuchi Station Building, mediVR Rehabilitation Center
TEL
81-06-6151-4008
hara@medivr.jp
Public contact
Name of contact person
| 1st name | Masahiko |
| Middle name | |
| Last name | Hara |
Organization
The Japan Society of Clinical Reesarch
Division name
Department of Clinical Investigation
Zip code
561-0871
Address
Higashiterauchi-cho 1-10-446, Toyonaka, Osaka
TEL
81-90-7593-2229
Homepage URL
hara@japanscr.org
Sponsor or person
Institute
mediVR Rehabilitation Center
Institute
Department
Personal name
Funding Source
Organization
NA
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Comittee of the Japan Society of Clinical Research
Address
Higashiterauchi-cho 1-10, Toyonaka, Osaka
Tel
81-90-7593-2229
info@japanscr.org
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 | 01 | Month | 04 | 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 | 01 | Month | 04 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 08 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 08 | Day |
Last follow-up date
| 2029 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Various indices will be measured and evaluated according to the underlying disease and condition, but these are not limited to them, and researchers may set indices that they consider necessary, such as disease-specific test indices and blood data (biomarkers), as evaluation items.
The timing of the assessments will be set arbitrarily for each patient, as it is epidemiological data. For example, it could be set at the time of the first visit, before and after the SCCT (for example, before and after the first and final treatment), or it could be set at intervals of approximately one month, three months, six months, nine months, and one year after the start of treatment, or it could be set at intervals of five or ten SCCT sessions.
Management information
Registered date
| 2025 | Year | 01 | Month | 04 | Day |
Last modified on
| 2025 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064717
