UMIN-CTR Clinical Trial

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
Email	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
Email	burin.dalila.c3@tohoku.ac.jp

Sponsor
Institute	Institute of Development, Aging and Cancer (IDAC), Tohoku University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052412