UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037911 |
|---|---|
| Receipt number | R000043213 |
| Scientific Title | Care prevention support system using health-care robot A intervention study on Kanagawa Me-Byo Prospective study |
| Date of disclosure of the study information | 2019/10/31 |
| Last modified on | 2024/03/06 14:05:59 |
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Basic information
Public title
Care prevention support system using health-care robot
Acronym
Care prevention support system using health-care robot
Scientific Title
Care prevention support system using health-care robot
A intervention study on Kanagawa Me-Byo Prospective study
Scientific Title:Acronym
Care prevention support system using health-care robot
Region
| Japan |
Condition
Condition
High risk people for care
Classification by specialty
| Medicine in general | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Feasibility study of training using robot-suit HAL
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Program completion rate
Key secondary outcomes
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
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Care prevention program using 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
| 30 | 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 who fall under flail or pre-foil in the Locomo degree check
Persons who meet flail and pre-flail standards (see table), or who have a locomotive degree of 1 (less than 1.3) or 2 (less than 1.1) in a two-step test
Key exclusion criteria
The exclusion criteria for pilot and baseline survey subjects are as follows.
Persons who cannot obtain informed consent from the person regarding the contents of the consent confirmation document
Person who has difficulty filling out questionnaire
In this exploratory intervention study, the following exclusion criteria are set.
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.
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 2 3F 3-25-10 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 2 3F 3-25-10 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
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Kanagawa University of Human Services
Address
Research Gate Building TONOMACHI 2-A 2 3F 3-25-10 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
| 2019 | Year | 10 | Month | 31 | Day |
Related information
URL releasing protocol
not a available
Publication of results
Unpublished
Result
URL related to results and publications
not a available
Number of participants that the trial has enrolled
22
Results
Of the 22 participants, 20 (91%) completed the program and showed improvement in physical function (walking speed and balance ability) and psycho-psychological aspects (self-efficiency and motivation).
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 people who have been determined to be frail or pre-frail
Participant flow
22 subjects recruited frail and pre-frail determined elderly
Adverse events
None
Outcome measures
Program completion rate
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2019 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 29 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 09 | Month | 03 | Day |
Last modified on
| 2024 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043213
