UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048939 |
|---|---|
| Receipt number | R000055759 |
| Scientific Title | Development of care prevention support program using health-care robot: an interventional study for implementation in nursing care settings based on Kanagawa Me-Byo Prospective study |
| Date of disclosure of the study information | 2022/09/15 |
| Last modified on | 2024/03/01 13:47:07 |
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Basic information
Public title
Development of care prevention support program using health-care robot: an interventional study for implementation in nursing care settings based on Kanagawa Me-Byo Prospective study
Acronym
Development of care prevention support program using health-care robot
Scientific Title
Development of care prevention support program using health-care robot: an interventional study for implementation in nursing care settings based on Kanagawa Me-Byo Prospective study
Scientific Title:Acronym
Development of care prevention support program 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 implementability of the frailty prevention program in nursing care settings using robot-suit HAL
Basic objectives2
Others
Basic objectives -Others
Implementability
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Frailty prevention program completion rate
Key secondary outcomes
Changes in lifestyle assessment items, socio-psychological measures, laboratory data, and physical findings before and after implementation of the program
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
A total of 10 training programs will be conducted twice a week using the robot-suit HAL
Interventions/Control_2
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
Persons who participate in Kanagawa Me-Byo Prospective Study
Persons who categorized in Support Care Level 1 to 2, Nursing Care Level 1 to 2, or who do not meet Certification of Needed Long-Term Care
Persons who can wear health care robot HAL(HALwaist type applicable body size guide: height 140-180cm, weight 80kg or less)
Persons who have never used health care robot HAL
No history of lumbar spinal canal stenosis, herniated disc, or lower limb occlusive arterial disease
Key exclusion criteria
Persons who cannot obtain informed consent from the person regarding the contents of the consent confirmation document
Persons who have difficulty filling out questionnaire
Persons who have difficulty communicating in Japanese
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 exercise intervention programs
Persons who are ordered by doctors to refrain from exercise
Persons who are an expecting mother
Persons who judge that it is inappropriate to implement an intervention program in view of physical and psychological burdens
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hiroto |
| Middle name | |
| Last name | Narimatsu |
Organization
Kanagawa University of Human Services
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
hiroto-narimatsu@umin.org
Public contact
Name of contact person
| 1st name | Hiroto |
| Middle name | |
| Last name | Narimatsu |
Organization
Kanagawa University of Human Services
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
hiroto-narimatsu@umin.org
Sponsor or person
Institute
Kanagawa University of Human Services
Graduate School of Health Innovation
Institute
Department
Personal name
Funding Source
Organization
Kanagawa Institute of Industrial Science and Technology
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kanagawa University of Human Services Graduate School of Health Innovation
Address
Research Gate Building TONOMACHI 2-A Tonomachi, Kawasaki-ku, Kawasaki-shi, Kanagawa
Tel
044-589-8100
health-innovation@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
| 2022 | Year | 09 | Month | 15 | Day |
Related information
URL releasing protocol
not available
Publication of results
Unpublished
Result
URL related to results and publications
not available
Number of participants that the trial has enrolled
18
Results
Of the 18 participants in the study, 14 were able to continue to participate until the tenth and final session of the exercise intervention program, and one was absent due to illness only at the final session, and was therefore considered to have completed the program according to the predefined definition. The completion rate, the primary endpoint, was 83.3%.
Results date posted
| 2024 | Year | 03 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Elderly men and women 65 years of age and older
No nursing care certification required or up to 2 years of nursing care required
Participant flow
18 people participated in the trial
Adverse events
not reported
Outcome measures
Completion rate
Plan to share IPD
Not applicable
IPD sharing Plan description
Not applicable
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2022 | Year | 09 | Month | 13 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 13 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2027 | 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
| 2022 | Year | 09 | Month | 14 | Day |
Last modified on
| 2024 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055759
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
