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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039435
Receipt No. R000044933
Scientific Title Improvement in Cognitive and Motor Functions of Healthy Older Adults Following a VR Program Intervention: A Randomized Controlled Trial
Date of disclosure of the study information 2020/02/08
Last modified on 2020/02/10

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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 Preinitiation
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 02 Month 10 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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