UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039435 |
|---|---|
| Receipt number | 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 | 2020/09/15 22:35:59 |
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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
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
atsuko.miyazaki.vj@riken.jp
Sponsor or person
Institute
RIKEN
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044933
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| Registered date | File name |
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