UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026992 |
|---|---|
| Receipt number | R000030950 |
| Scientific Title | Exercise intensity and enjoyment of balance exercise using a virtual reality device in community dwelling elderly people |
| Date of disclosure of the study information | 2017/04/17 |
| Last modified on | 2018/02/21 18:01:45 |
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Basic information
Public title
Exercise intensity and enjoyment of balance exercise using a virtual reality device in community dwelling elderly people
Acronym
Exercise intensity and enjoyment of balance exercise using a virtual reality device
Scientific Title
Exercise intensity and enjoyment of balance exercise using a virtual reality device in community dwelling elderly people
Scientific Title:Acronym
Exercise intensity and enjoyment of balance exercise using a virtual reality device
Region
| Japan |
Condition
Condition
Community dwelling healthy elderly people
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess whther exercise using a virtual reality device is effective for improving and maintain physical function of elderly people
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Functional reach before and after intervention
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Balance excercise using a virtual reality device (10 minutes)
Interventions/Control_2
Usual balance exercise without a virtual reality device (10 minutes)
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
Community dwelling elderly people who use a health and welfare center
Key exclusion criteria
People who cannot communicate with others
People whose eyesight is significantly poor
People who caanot excercise because of their disorders
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Daisuke Higuchi |
Organization
Takasaki University of Health and Welfare
Division name
Department of Physical Therapy
Zip code
Address
501 Nakaorui-machi, Takasaki-Shi, Gunma 370-0033, Japan
TEL
+81-27-352-1291
higuchi-d@takasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daisuke Higuchi |
Organization
Takasaki University of Health and Welfare
Division name
Department of Physical Therapy
Zip code
Address
501 Nakaorui-machi, Takasaki-Shi, Gunma 370-0033, Japan
TEL
+81-27-352-1291
Homepage URL
higuchi-d@takasaki-u.ac.jp
Sponsor or person
Institute
Takasaki University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Takasaki University of Health and Welfare
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
Address
Tel
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
| 2017 | Year | 04 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Lateral dynamic balance of the virtual reality balance exercise group improved greater than that of the usual barance exercise (control) group.
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
| 2017 | Year | 04 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | Month | 24 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 14 | Day |
Last modified on
| 2018 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030950
