UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045920 |
|---|---|
| Receipt number | R000052412 |
| Scientific Title | Impact of sharing known experiences in immersive virtual reality on the quality of life of older people |
| Date of disclosure of the study information | 2021/12/17 |
| Last modified on | 2021/12/17 09:08:35 |
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Basic information
Public title
Impact of sharing known experiences in immersive virtual reality on the quality of life of older people
Acronym
IVR and shared experiences on memory
Scientific Title
Impact of sharing known experiences in immersive virtual reality on the quality of life of older people
Scientific Title:Acronym
IVR and shared experiences on memory
Region
| Japan |
Condition
Condition
memory problems
Classification by specialty
| Geriatrics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is IVR intervention, which allows healthy elderly people to share their experiences of watching famous places (such as "cherry blossoms" along the river) and events (such as traditional festivals in the area) (multiplayer mode). To assess the impact on several areas of quality of life (social, cognitive, emotional, and motor areas) using a specific test battery.
The idea of this study is emotional (by known places and events), cognitive (by exploring virtual space), and social (because of multiplayer mode) that contribute to improving quality of life through IVR intervention. , To activate the behavioral aspect (due to the involvement of IVR).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
no specific putcome
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
The IVR intervention consists of 12 sessions (from session 2 to session 13 of this RCT) performed twice a week for 6 weeks continuously, for 15 minutes each session. The subject randomly assigned to the Intervention group, all together in a group session, will all wear the headset-mounted display (one for each of them). The first 3 minutes will be important for acclimatization and familiarization with the setup and the IVR environment. Once sure that none of the subjects feels uncomfortable, the intervention starts: they will all see the same 3D videos; each session the images are different, but they all show famous spots and places that evoke positive memories and feelings. Because it is a shared situation, it will possible for them to talk and discuss their ongoing experiences. Although, they will not be able to walk, but they have to stay sit for safety reasons ; they are allowed to explore the environment by rotating their heads. Also, the 3D images and videos will play in a natural way, giving the impression that they are actually immersed there.
Interventions/Control_2
The Intervention group only will perform the IVR intervention, while the Control group does not do it.
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
| 60 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The subjects are 60 men and women between the ages of 60 and 85, whose mother tongue is Japanese.
Key exclusion criteria
Those with a history of motor and sensory organs.
Those with a history of locomotor disorders.
Those with a history of walking or posture disorders.
Those with a history of mental illness.
Those taking medications that may affect cognitive or motor function (eg, benzodiazepines, antidepressants, central nervous system medications).
Things that are prone to motion sickness.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Ryuta |
| Middle name | |
| Last name | Kawashima |
Organization
Institute of Development, Aging and Cancer (IDAC), Tohoku University
Division name
Department of Functional Brain Imaging
Zip code
980-8575
Address
4-1 Seiryocho, Aobaku, Sendai 980-8575, Japan
TEL
022-717-7988
ryuta.kawashima.a6@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Dalila |
| Middle name | Burin |
| Last name | Burin |
Organization
Institute of Development, Aging and Cancer (IDAC), Tohoku University
Division name
Smart-Aging International Research Center (SAIRC)
Zip code
980-8575
Address
4-1 Seiryocho, Aobaku, Sendai 980-8575, Japan
TEL
022-717-7988
Homepage URL
burin.dalila.c3@tohoku.ac.jp
Sponsor or person
Institute
Institute of Development, Aging and Cancer (IDAC), Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
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
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryocho, Aobaku, Sendai 980-8575, Japan
Tel
022-717-8007
med-kenkyo@grp.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 12 | Month | 17 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 10 | Month | 29 | Day |
Last modified on
| 2021 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052412
