UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034816 |
|---|---|
| Receipt number | R000039705 |
| Scientific Title | Development of a rehabilitation system combining 3DVR and haptic technology |
| Date of disclosure of the study information | 2019/01/10 |
| Last modified on | 2022/06/20 04:42:50 |
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Basic information
Public title
Development of a rehabilitation system combining 3DVR and haptic technology
Acronym
Development of a rehabilitation system combining 3DVR and haptic technology
Scientific Title
Development of a rehabilitation system combining 3DVR and haptic technology
Scientific Title:Acronym
Development of a rehabilitation system combining 3DVR and haptic technology
Region
| Japan |
Condition
Condition
Healthy person
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Using the 3-dimensional virtual reality system, we will examine the physiological changes in elderly people and young people and use them as the basic knowledge of future development of rehabilitation system
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
EEG, GSR, heart rate variability, pulse wave, movement accuracy, center of gravity, motion analysis
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
3D VR
Interventions/Control_2
3D AR
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
| 89 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy person
Key exclusion criteria
Persons with visual abnormality
Those who can not understand Japanese
Those who are not permitted to exercise
Person who is sensitive to light stimulus etc.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Ryoichi |
| Middle name | |
| Last name | Nagatomi |
Organization
Tohoku University
Division name
Biomedical Engineering
Zip code
9800845
Address
2-8 Seiryo-machi Aobaku Sendai-shi, Japan
TEL
0227522206
keizo@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Sato |
| Middle name | |
| Last name | Keizo |
Organization
Tohoku University
Division name
Biomedical Engineering
Zip code
980-0845
Address
2-8 Seiryo-machi Aobaku Sendai-shi, Japan
TEL
0227522206
Homepage URL
keizo@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education Culture Sports Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku University
Address
2-8 Seiryo-machi Aobaku Sendai-shi, Japan
Tel
0227522206
keizo@med.tohoku.ac.jp
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
国）東北大学
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 01 | Month | 10 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 17 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 11 | Month | 08 | Day |
Last modified on
| 2022 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039705
