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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026992
Receipt No. 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

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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
Email 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
Email higuchi-d@takasaki-u.ac.jp

Sponsor
Institute Takasaki University of Health and Welfare
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030950

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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