UMIN-CTR Clinical Trial

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
Email	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/
Email	hara@japanscr.org

Sponsor
Institute	The Japan Society of Clinical Research Department of Clinical Investigation
Institute
Department

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
Email

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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033891

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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