UMIN-CTR Clinical Trial

Basic information
Public title	Effects of immersive VR reminerations for behavioral and psychological symptoms associated with dementia
Acronym	Effects of immersive VR reminerations
Scientific Title	Effects of immersive VR reminerations for behavioral and psychological symptoms associated with dementia
Scientific Title:Acronym	Effects of immersive VR reminerations
Region	Japan

Condition
Condition	dementia
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	For dementia patients, it aims to examine whether to promote the improvement of BPSD symptoms such as experience anxiety and depression, a more realistic and sense of immersive VR reminiscence
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Neuropsychiatric Inventory Q
Key secondary outcomes	Mini-Mental State Examination

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	Other
Interventions/Control_1	In addition to regular occupational therapy intervention, we experience immersive VR reminiscence once 5 to 15 minutes, 3 times a week 4 weeks
Interventions/Control_2	Perform regular occupational therapy intervention 60 minutes every day
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	65 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	We can obtain consent from the person who is research target person and family in this research content Elderly people over 65 years old Dementia screening examination or less in cutoff value We present some BPSD symptoms such as insomnia and depression
Key exclusion criteria	Severe vision, hearing impaired It is difficult to install equipment There is mental illness such as depression and schizophrenia Epilepsy seizures and migraine Hypersensitive to ride and light If there is an electronic device such as a defibrillator or the like using a pacemaker or a hearing aid or near the subject. Clinical judgment of doctor
Target sample size	66

Research contact person
Name of lead principal investigator	1st name Shouta Middle name Last name Kaneko
Organization	Graduate School of Hokkaido Bunkyo University
Division name	Research on Rehabilitation Science
Zip code	061-1449
Address	5-196-1, koganechuo, Eniwa city, Hokkaido
TEL	0120-240-552
Email	shoutak@do-bunkyodai.ac.jp

Public contact
Name of contact person	1st name Shouta Middle name Last name Kaneko
Organization	Graduate School of Hokkaido Bunkyo University
Division name	Research on Rehabilitation Science
Zip code	061-1449
Address	5-196-1, koganechuo, Eniwa city, Hokkaido
TEL	0120-240-552
Homepage URL
Email	shoutak@do-bunkyodai.ac.jp

Sponsor
Institute	Others
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Hanakawa Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Graduate School of Hokkaido Bunkyo University
Address	5-196-1, koganechuo, Eniwa city, Hokkaido
Tel	0120-240-552
Email	shoutak@do-bunkyodai.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	医療法人喬成会花川病院

Other administrative information
Date of disclosure of the study information	2022 Year 04 Month 23 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	Enrolling by invitation
Date of protocol fixation	2022 Year 04 Month 23 Day
Date of IRB	2021 Year 11 Month 02 Day
Anticipated trial start date	2022 Year 04 Month 23 Day
Last follow-up date	2027 Year 04 Month 23 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 04 Month 23 Day
Last modified on	2022 Year 04 Month 23 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054252