UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035044 |
|---|---|
| Receipt number | 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 | 2023/06/02 09:51:46 |
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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 | Izumi |
| Middle name | |
| Last name | Kondo |
Organization
National Center for Geriatrics and Gerontology
Division name
Center of Assistive Robotics and Rehabilitation for Longevity and Good Health
Zip code
474-8511
Address
7-430, Moriokacho, Obu-shi, Aichi, 474-8511, Japan
TEL
0562-46-2311
ik7710@ncgg.go.jp
Public contact
Name of contact person
| 1st name | Izumi |
| Middle name | |
| Last name | Kondo |
Organization
National Center for Geriatrics and Gerontology
Division name
Assistive robot center
Zip code
474-8511
Address
7-430, Moriokacho, Obu-shi, Aichi, 474-8511, Japan
TEL
0562-46-2311
Homepage URL
ik7710@ncgg.go.jp
Sponsor or person
Institute
Kizankai Memorial Hospital
Institute
Department
Personal name
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
National center for geriatrics and gerontology
Address
430, 7chome, Moriokachou, Obu
Tel
0562462311
ik7710@ncgg.go.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
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
https://www.ncgg.go.jp
Publication of results
Unpublished
Result
URL related to results and publications
https://www.ncgg.go.jp
Number of participants that the trial has enrolled
20
Results
Approvement of efficiency similar to the ordinal exercise
Results date posted
| 2023 | Year | 06 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
participants to day care service
Participant flow
Ordinal
Adverse events
None
Outcome measures
ADL, Cognitive function
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2018 | Year | 06 | Month | 29 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 29 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 21 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
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
| 2023 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039954
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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