UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041773 |
|---|---|
| Receipt number | 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 | 2021/05/03 20:37:44 |
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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 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)
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) Functional Reach Test(FRT)
5) 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
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
info@japanscr.org
Sponsor or person
Institute
Muroi Medical Office
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
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
40
Results
This study was terminated due to the transfer of the principal investigator because rehabilitation could not be performed on study participants for a long period of time due to the pandemic of COVID-19 infectious disease.
Results date posted
| 2021 | Year | 05 | Month | 03 | 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 | 08 | Month | 21 | Day |
Last follow-up date
| 2021 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
NA
Management information
Registered date
| 2020 | Year | 09 | Month | 13 | Day |
Last modified on
| 2021 | Year | 05 | Month | 03 | Day |
Link to view the page
Value
https://center6.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 |
