UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059607 |
|---|---|
| Receipt number | R000068116 |
| Scientific Title | Ergonomic Study of Integrated Transfer and Mobility Assistive Devices |
| Date of disclosure of the study information | 2025/11/04 |
| Last modified on | 2025/10/27 17:50:02 |
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Basic information
Public title
Ergonomic Study of Integrated Transfer and Mobility Assistive Devices
Acronym
Evaluation Test of Assistive Devices
Scientific Title
Ergonomic Study of Integrated Transfer and Mobility Assistive Devices
Scientific Title:Acronym
Evaluation Test of Assistive Devices
Region
| Japan |
Condition
Condition
Low Back Pain, Sarcopenia
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We are developing a wheelchair equipped with a transfer mechanism that enables both transfer and mobility assistance in a single device, designed for elderly residents in care facilities who have difficulty walking but retain some ability to stand. This development aims to reduce the workload of caregivers while increasing opportunities for residents to utilize their remaining muscle strength, thereby contributing to improved productivity in caregiving environments.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Integrated EMG value, percentage of maximum voluntary contraction (%MVC), amplitude probability distribution function (APDF) of EMG, pressure distribution, and working time
Key secondary outcomes
Subjective Assessment
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Transfer using the prototype device
Interventions/Control_2
Transfer using a product of competitoon
Interventions/Control_3
Manual transfer (by hand)
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Individuals who can voluntarily participate in the study
Key exclusion criteria
Men: Height 172 cm or taller, Weight 75 kg or more
Women: Height 160 cm or taller, Weight 65 kg or more
Individuals with severe low back pain or joint pain
Individuals who have undergone orthopedic surgery within the past three months
ndividuals with serious cardiovascular or respiratory diseases
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | Yi |
| Last name | Yoto |
Organization
Industrial Research Institute of Shizuoka Prefecture
Division name
Department of Universal Design
Zip code
4211298
Address
2078 Makigaya, Aoi-ku, Shizuoka-shi, Shizuoka, Japan
TEL
054-278-3024
sk-ud@pref.shizuoka.lg.jp
Public contact
Name of contact person
| 1st name | Tsuyoshi |
| Middle name | Yi |
| Last name | Yoto |
Organization
Industrial Research Institute of Shizuoka Prefecture
Division name
Department of Universal Design
Zip code
4211298
Address
2078 Makigaya, Aoi-ku, Shizuoka-shi, Shizuoka, Japan
TEL
054-278-3024
Homepage URL
sk-ud@pref.shizuoka.lg.jp
Sponsor or person
Institute
Industrial Research Institute of Shizuoka Prefecture
Institute
Department
Personal name
Funding Source
Organization
Industrial Research Institute of Shizuoka Prefecture
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
JATCO Ltd
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Industrial Research Institute of Shizuoka Prefecture
Address
2078 Makigaya, Aoi-ku, Shizuoka-shi, Shizuoka, Japan
Tel
054-278-3024
sk-ud@pref.shizuoka.lg.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
| 2025 | Year | 11 | Month | 04 | 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
| 2025 | Year | 11 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 11 | Month | 04 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2027 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 10 | Month | 31 | Day |
Last modified on
| 2025 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068116
