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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000041773
Receipt No. R000047678
Scientific Title Exploratory observational study on the usefulness of virtual reality-guided rehabilitation
Date of disclosure of the study information 2020/09/13
Last modified on 2020/09/13

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Basic information
Public title Exploratory observational study on the usefulness of virtual reality-guided rehabilitation
Acronym VR rehabilitation study
Scientific Title Exploratory observational study on the usefulness of virtual reality-guided rehabilitation
Scientific Title:Acronym VR rehabilitation study
Region
Japan

Condition
Condition Patients with physical or cognitive disabilities
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of mediVR KAGURA in an exploratory observational design
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Following indices at discharge or 6 months after the implementation of mediVR KAGURA-guided therapy:
1) Timed Up & Go test(TUG)
2) Functional Reach Test(FRT)
3) HDS-R
Key secondary outcomes Following indices at discharge or 6 months after the implementation of mediVR KAGURA-guided therapy:
1) hand grip
2) 10m walk time
3) knee extension muscle strength
4) Mini-Mental State Examination (MMSE) score
5) Frontal Assessment Battery (FAB) score
6) Self-Rating Depression Scale (SDS) score

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
20 years-old <=
Age-upper limit
110 years-old >=
Gender Male and Female
Key inclusion criteria 1) Persons who are hospitalized, occupying, or using the related facilities of Muroi Medical Office to which the principal investigator belongs
2) A person who has obtained written consent by his / her free will
Key exclusion criteria 1) Persons with severe disturbance of consciousness
2) The target person or the information provider is not a Japanese speaker or cannot read or write Japanese
3) When the principal investigator or the research coordinator determines that participation in this research is inappropriate.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Yasunori
Middle name
Last name Kouyama
Organization Muroi Medical Office
Division name Department of Rehabilitation
Zip code 671-1522
Address Yatabe 335-1, Taishi-cho, Ibo-gun, Hyogo, Japan
TEL 072-277-0531
Email info@japanscr.org

Public contact
Name of contact person
1st name Masatake
Middle name
Last name Tamaki
Organization Japan Society of Clinical Research
Division name Department of Clinical Investigation
Zip code 530-0001
Address Kita-ku Umeda 1-11-4-1000 Osaka Ekimae 4th Bldg 10F Osaka, 530-0001 Japan
TEL 06-6131-5495
Homepage URL
Email info@japanscr.org

Sponsor
Institute Muroi Medical Office
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 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
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 Enrolling by invitation
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 08 Month 21 Day
Last follow-up date
2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information NA

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=R000047678

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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