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UMIN-CTR Clinical Trial |
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Name | UMIN ID |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000029659 |
Receipt No. | 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 |
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 |
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Condition | ||
Condition | healthy subject | |
Classification by specialty |
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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 |
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Interventions/Control_1 | Usage of mediVR01 device
roughly 10-20 minutes |
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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 |
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Age-upper limit |
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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) |
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Target sample size | 30 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 | |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |