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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035044
Receipt No. R000039954
Scientific Title The verification of effect of program of care prevention by Japanese dancing using human shaped robot for the purpose of improving physical and cognitive function.
Date of disclosure of the study information 2018/11/30
Last modified on 2018/11/28

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Basic information
Public title The verification of effect of program of care prevention by Japanese dancing using human shaped robot for the purpose of improving physical and cognitive function.
Acronym The effect of program of care prevention using robot
Scientific Title The verification of effect of program of care prevention by Japanese dancing using human shaped robot for the purpose of improving physical and cognitive function.
Scientific Title:Acronym The effect of program of care prevention using robot
Region
Japan

Condition
Condition Frail or pre-frail elderly
Classification by specialty
Geriatrics Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aims the verification of effect of program of care prevention by Japanese dancing using human shaped robot.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Questionnaire for robotic activity by Visual Analog Scale (VAS) after 4 week intervention
Key secondary outcomes Reaction scale, Kihon check list, about subjective health impression, Body Mass Index (BMI), height, weight, Vitality Index, upper arm circumference of upper arm and below-knee, grip strength, time of one leg stand, Timed Up and Go (TUG), 5m gait time, Mini Mental State Examination (MMSE), copying of three-dimensional figure, vegetables recall, Symbol Digit Modalities Test (SDMT), Fall Risk Index (FRI)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment Behavior,custom Maneuver
Interventions/Control_1 Traditional activity group: 45min./time, twice a week and for three weeks.
Interventions/Control_2 Robotic activity group: 45min./time, twice a week and for three weeks.
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 participants were care recipients who used the day care service of nursing home twice or more a week between June 29, 2018 to July 31, 3018, they didn't limit by their diagnosis.
Key exclusion criteria 1) subjects with severe dementia who did not understand the explanation of this study
2) subjects who not be able to sit on a chair one hour
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Izumi Kondo
Organization National Center for Geriatrics and Gerontology
Division name Center of Assistive Robotics and Rehabilitation for Longevity and Good Health
Zip code
Address 7-430, Moriokacho, Obu-shi, Aichi, 474-8511, Japan
TEL 0562-46-2311
Email ik7710@ncgg.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Izumi Kondo
Organization National Center for Geriatrics and Gerontology
Division name Center of Assistive Robotics and Rehabilitation for Longevity and Good Health
Zip code
Address 7-430, Moriokacho, Obu-shi, Aichi, 474-8511, Japan
TEL 0562-46-2311
Homepage URL
Email ik7710@ncgg.go.jp

Sponsor
Institute Kizankai Memorial Hospital
Institute
Department

Funding Source
Organization Fujita Health University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor nursing home, omotoen
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 医療法人輝山会介護老人保健施設万年青苑

Other administrative information
Date of disclosure of the study information
2018 Year 11 Month 30 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 Enrolling by invitation
Date of protocol fixation
2018 Year 06 Month 29 Day
Date of IRB
Anticipated trial start date
2018 Year 07 Month 21 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
2018 Year 11 Month 28 Day
Last modified on
2018 Year 11 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039954

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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