UMIN-CTR Clinical Trial

Basic information
Public title	Improvement in Cognitive and Motor Functions of Older Adults Following a VR Program Intervention: A Randomized Controlled Trial
Acronym	Cognitive and Motor Functions Following a VR Program Intervention
Scientific Title	Improvement in Cognitive and Motor Functions of Healthy Older Adults Following a VR Program Intervention: A Randomized Controlled Trial
Scientific Title:Acronym	Cognitive and Motor Functions Following a VR Program Intervention
Region	Japan

Condition
Condition	Dementia, Mild Cognitive Impairment, Normal elderly, Lewy body dementia, Cerebrovascular disease, Cerebral infarction, Cerebral contusion, Cerebral hemorrhage, Aftereffect of cerebral hemorrhage, Basilar artery occlusion, Cerebral arteriosclerosis, Multiple cerebral infarction, Cerebral atrophy, Vascular dementia, Chronic subdural hematoma, Parkinson's disease, Parkinsonian syndrome, Bone and joint disease, Osteoporosls, Chronic articular rheumatism, Hemiparesis, Diabetes, Disuse syndrome, Locomotive Syndrome, Sarcopenia and frailty.
Classification by specialty	Psychiatry Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to examine the beneficial effect on cognitive and physical function by the VR program.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The 3D visuospatial test is compared before and after intervention for four weeks.
Key secondary outcomes	The neuropsychological testing and assessment for dementia (Mini-Mental State Examination, Instruction manual of the Japanese version of Montreal Cognitive Assessment, A Frontal Assessment Battery at bedside), Geriatric Depression Scale, WHO Quality of Life-BREF, the range of motion of the cervical spine range of motion

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	No treatment
Stratification	YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Device,equipment Behavior,custom
Interventions/Control_1	The VR intervention group attends 30 minutes of the VR program with HMD thrice a week for 4 weeks.
Interventions/Control_2	The waitlisted group does not participate in the intervention. After 4 weeks, there is the program as a service session.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Continue to participate in experiments thrice a week. 2)Continue to participate in the experiment for 4 weeks.
Key exclusion criteria	1) Dementia. 2) Blind, full deafness.
Target sample size	32

Research contact person
Name of lead principal investigator	1st name Atsushi Middle name Last name Hiyama
Organization	RIKEN
Division name	Physical Intelligence Transfer Technology Team
Zip code	103-0027
Address	5th floor, 1-4-1 Nihonbashi,Chuo-ku, Tokyo
TEL	+81(0)03-6225-2373
Email	atsushi.hiyama@riken.jp

Public contact
Name of contact person	1st name Atsuko Middle name Last name Miyazaki
Organization	RIKEN
Division name	Computational Engineering Applications Unit
Zip code	351-0198
Address	2-1 Hirosawa, Wako, Saitama 351-0198 Japan
TEL	+81(0)48-467-4952
Homepage URL
Email	atsuko.miyazaki.vj@riken.jp

Sponsor
Institute	RIKEN
Institute
Department

Funding Source
Organization	RIKEN
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	RIKEN, Bio Safety and Ethics Section
Address	2-1 Hirosawa, Wako, Saitama 351-0198 Japan
Tel	+81(0)48-467-9293
Email	human@riken.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	2020 Year 02 Month 08 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	Completed
Date of protocol fixation	2020 Year 01 Month 09 Day
Date of IRB	2020 Year 02 Month 06 Day
Anticipated trial start date	2020 Year 02 Month 15 Day
Last follow-up date	2020 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	2020 Year 02 Month 08 Day
Last modified on	2020 Year 09 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044933