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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042352
Receipt No. R000048345
Scientific Title Care prevention support system using health-care robot A randomized controlled trial based on Kanagawa Me-Byo Prospective study
Date of disclosure of the study information 2020/11/09
Last modified on 2020/11/13

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Basic information
Public title Care prevention support system using health-care robot
A randomized controlled trial based on Kanagawa Me-Byo Prospective study
Acronym Care prevention support system using health-care robot
Scientific Title Care prevention support system using health-care robot
A randomized controlled trial based on Kanagawa Me-Byo Prospective study
Scientific Title:Acronym Care prevention support system using health-care robot
Region
Japan

Condition
Condition Frailty
Classification by specialty
Geriatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the frailty prevention effects of training program using robot-suit HAL
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Walking speed
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification YES
Dynamic allocation
Institution consideration
Blocking YES
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Device,equipment
Interventions/Control_1 A total of 10 training programs will be conducted twice a week using the robot-suit HAL
Interventions/Control_2 Five weeks after enrollment, a total of 10 training programs will be conducted twice a week using the robot-suit HAL.
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
85 years-old >=
Gender Male and Female
Key inclusion criteria Persons who can wear HAL (HAL waist type applicable body size guide: height 140-180cm, weight 80kg or less)
Persons with a cutoff value of 6 points or more on the Locomo 5 questionnaire and / or persons with a normal walking speed of less than 1.0 m/sec
Persons who have not received certification of needed long-term care
Key exclusion criteria Persons who cannot obtain informed consent from the person regarding the contents of the consent confirmation document
Person who has difficulty filling out questionnaire
Those who have difficulty communicating in Japanese
Those who judge that it is inappropriate to implement an intervention program in view of physical and psychological burdens
Persons who have difficulty wearing HAL due to body size disagreement such as weight, thigh length, lower leg length, waist width, or due to large deformation of the body
Persons who are judged by a doctor to be inappropriate for wearing or using HAL, such as improper standing / walking exercises
Persons who cannot attach electrodes due to skin diseases or allergies
Persons who cannot take measures to prevent falls
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Hiroto
Middle name
Last name Narimatsu
Organization Kanagawa University of Human Service
Division name Graduate School of Health Innovation
Zip code 210-0821
Address Research Gate Building TONOMACHI 2-A Tonomachi, Kawasaki-ku, Kawasaki-shi, Kanagawa
TEL 044-589-8100
Email hiroto-narimatsu@umin.org

Public contact
Name of contact person
1st name Hiroto
Middle name
Last name Narimatsu
Organization Kanagawa University of Human Service
Division name Graduate School of Health Innovation
Zip code 210-0821
Address Research Gate Building TONOMACHI 2-A Tonomachi, Kawasaki-ku, Kawasaki-shi, Kanagawa
TEL 044-589-8100
Homepage URL
Email hiroto-narimatsu@umin.org

Sponsor
Institute Kanagawa University of Human Service
Institute
Department

Funding Source
Organization MEXT
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Graduate School of Health Innovation, Kanagawa University of Human Service
Address Research Gate Building TONOMACHI 2-A Tonomachi, Kawasaki-ku, Kawasaki-shi, Kanagawa
Tel 044-589-8100
Email okubo-h2e@kuhs.ac.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 11 Month 09 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 Preinitiation
Date of protocol fixation
2020 Year 10 Month 13 Day
Date of IRB
2020 Year 10 Month 26 Day
Anticipated trial start date
2020 Year 11 Month 12 Day
Last follow-up date
2023 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
2020 Year 11 Month 05 Day
Last modified on
2020 Year 11 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048345

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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