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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000041771
Receipt No. 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 2020/09/13

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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
Email 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
Email hara@cloudclinic.online

Sponsor
Institute Cloud Clinic
Institute
Department

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
Email 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
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
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
Date trial data considered complete
Date analysis concluded

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
2020 Year 09 Month 13 Day


Link to view the page
URL(English) https://upload.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


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