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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029659
Receipt No. R000033891
Official scientific title of the study 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

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Basic information
Official scientific title of the study First-in-man study of virtual reality technology-based dual task exercise rehabilitation system (mediVR01)
Title of the study (Brief title) 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 Masahiko Hara
Organization The Japan Society of Clinical Research
Division name Department of Clinical Investigation
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 Masahiko Hara
Organization The Japan Society of Clinical Research
Division name Department of Clinical Investigation
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)

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

Progress
Recruitment status Completed
Date of protocol fixation
2017 Year 10 Month 22 Day
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

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
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://upload.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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