UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029659 |
|---|---|
| Receipt number | R000033891 |
| Scientific Title | First-in-man study of virtual reality technology-based dual task exercise rehabilitation system (mediVR01) |
| Date of disclosure of the study information | 2017/10/23 |
| Last modified on | 2018/04/22 11:30:45 |
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Basic information
Public title
First-in-man study of virtual reality technology-based dual task exercise rehabilitation system (mediVR01)
Acronym
mediVR01 Study-1
Scientific Title
First-in-man study of virtual reality technology-based dual task exercise rehabilitation system (mediVR01)
Scientific Title:Acronym
mediVR01 Study-1
Region
| Japan |
Condition
Condition
healthy subject
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of mediVR01 device
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety of mediVR01 (incidence of bad condition) immediately after the device usage
Key secondary outcomes
1. Safety of mediVR01 (incidence of bad condition) during 3 days after the device usage
2. Evaluation of body trunk balancing using distance information
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Usage of mediVR01 device
roughly 10-20 minutes
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Adults who can agree with the study design by themselves with informed consent
Key exclusion criteria
1. Present medical history of dizziness and vertigo
2. Poor visual acuity despite correction
3. Present medical history of epilepsy
4. Sever hypotension
5. Study population of other clinical studies within 3 months
6. Patients with psychiatric disorder
7. Inappropriate candidates (attending physician's discretion)
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiko Hara |
Organization
The Japan Society of Clinical Research
Division name
Department of Clinical Investigation
Zip code
Address
Kita-ku Umeda 1-11-1000 Osaka Ekimae 4th Bldg 10F Osaka, 530-0001 Japan
TEL
06-6318-6234
hara@japanscr.org
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiko Hara |
Organization
The Japan Society of Clinical Research
Division name
Department of Clinical Investigation
Zip code
Address
Kita-ku Umeda 1-11-1000 Osaka Ekimae 4th Bldg 10F Osaka, 530-0001 Japan
TEL
06-6318-6234
Homepage URL
https://www.japanscr.org/
hara@japanscr.org
Sponsor or person
Institute
The Japan Society of Clinical Research
Department of Clinical Investigation
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
一般社団法人 日本臨床研究学会
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 23 | 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
Completed
Date of protocol fixation
| 2017 | Year | 10 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 11 | Month | 11 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 28 | Day |
Date of closure to data entry
| 2017 | Year | 12 | Month | 28 | Day |
Date trial data considered complete
| 2018 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2018 | Year | 02 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 22 | Day |
Last modified on
| 2018 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033891
