UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041771 |
|---|---|
| Receipt number | R000047677 |
| Scientific Title | Cross-sectional observational study to evaluate the association between physical and cognitive indices and data captured by mediVR KAGURA |
| Date of disclosure of the study information | 2020/09/13 |
| Last modified on | 2023/03/17 10:55:47 |
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Basic information
Public title
Cross-sectional observational study to evaluate the association between physical and cognitive indices and data captured by mediVR KAGURA
Acronym
Cross-sectional observational study of mediVR KAGURA
Scientific Title
Cross-sectional observational study to evaluate the association between physical and cognitive indices and data captured by mediVR KAGURA
Scientific Title:Acronym
Cross-sectional observational study of mediVR KAGURA
Region
| Japan |
Condition
Condition
Non-identified (including healthy volunteers and patients with any kind of diseases)
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate associations between physical and cognitive indices and data captured by mediVR KAGURA
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Timed up and go test(TUG), Functional Independence Measure(FIM), and Trail Making Test (TMT)
Key secondary outcomes
Physical and cognitive indices other than primary outcomes such as 10m walk test, Berg balance scale, stabilograph parameters, Mini-Mental State Examination, HDS-R, Self-Rating Depression Scale, etc
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
| 6 | years-old | <= |
Age-upper limit
| 110 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Agreed to the participation of this study with written informed consent by themselves or guardians
Key exclusion criteria
1. Inappropriate candidates at attending physician's discretion
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Masahiko |
| Middle name | |
| Last name | Hara |
Organization
Cloud Clinic
Division name
Department of Clinical Investigation
Zip code
6650066
Address
Nigawadanchi 4-1, Takarazuka, Hyogo, Japan
TEL
0798317588
hara@cloudclinic.online
Public contact
Name of contact person
| 1st name | Masahiko |
| Middle name | |
| Last name | Hara |
Organization
Cloud Clinic
Division name
Department of Clinical Investigation
Zip code
6650066
Address
Nigawadanchi 4-1, Takarazuka, Hyogo, Japan
TEL
0798317588
Homepage URL
hara@cloudclinic.online
Sponsor or person
Institute
Cloud Clinic
Institute
Department
Personal name
Funding Source
Organization
NA
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
Japan Society of Clinical Research
Address
Kita-ku Umeda 1-11-4-1000 Osaka Ekimae 4th Bldg 10F Osaka, 530-0001 Japan
Tel
06-6131-5495
hara@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
| 2020 | Year | 09 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
NA
Number of participants that the trial has enrolled
696
Results
Not disclosed (used as data for preparing patent specifications).
Results date posted
| 2023 | Year | 03 | Month | 17 | Day |
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
Completed
Date of protocol fixation
| 2020 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2023 | Year | 02 | Month | 28 | Day |
Other
Other related information
To evaluate associations between physical and cognitive indices and data captured by mediVR KAGURA
Management information
Registered date
| 2020 | Year | 09 | Month | 13 | Day |
Last modified on
| 2023 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047677
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
