UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042352 |
|---|---|
| Receipt number | 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 | 2024/11/12 14:40:19 |
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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
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
hiroto-narimatsu@umin.org
Sponsor or person
Institute
Kanagawa University of Human Service
Institute
Department
Personal name
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
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
| 2020 | Year | 11 | Month | 09 | Day |
Related information
URL releasing protocol
https://doi.org/10.1016/j.exger.2024.112536
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1016/j.exger.2024.112536
Number of participants that the trial has enrolled
79
Results
The mean difference (standard error) between the groups for the primary outcome (usual walking speed) was 0.35 (0.04) m/s; the time-by-group interaction was significant (p < 0.001). Secondary outcomes (maximum walking speed, Timed Up and Go test results, 5-times chair-standing test results, and GLFS-5 scores) significantly improved in the intervention group. Body composition was unchanged in both groups.
Results date posted
| 2024 | Year | 11 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Elderly people diagnosed as frail or pre-frail
Participant flow
This randomized, single-blind, parallel-group study involved 79 community-dwelling older adults with physical frailty or locomotive syndrome assigned to an intervention group (n = 40) with the HAL lumbar type exercise program or a control group (n = 39) without the exercise program. The intervention group underwent trunk training (including trunk and hip flexion, standing and sitting from a single sitting position, and squats) and gait training (treadmill and parallel bars) twice a week for 5 weeks while wearing the HAL lumbar type.
Adverse events
None
Outcome measures
The 10-m usual and maximum walking speeds, Timed Up and Go test results, 5-times chair-standing test results, 5-question Geriatric Locomotive Function Scale (GLFS-5) scores, body-fat percentage, and muscle mass were measured before and after the intervention and analyzed using the intention-to-treat method.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2024 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048345
