UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062156 |
|---|---|
| Receipt number | R000071130 |
| Scientific Title | The effects of transfer assistive devices on the physical impact of both caregivers and care recipients |
| Date of disclosure of the study information | 2026/07/07 |
| Last modified on | 2026/07/07 11:18:15 |
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Basic information
Public title
The effects of transfer assistive devices on the physical impact of both caregivers and care recipients
Acronym
The effects of transfer assistive devices on the physical impact of both caregivers and care recipients
Scientific Title
The effects of transfer assistive devices on the physical impact of both caregivers and care recipients
Scientific Title:Acronym
The effects of transfer assistive devices on the physical impact of both caregivers and care recipients
Region
| Japan |
Condition
Condition
Staffs and students who are part of our university
Nursing staffs who are part of our hospital and collaborative institutions
Outpatients and inpatients from our hospital and collaborative institutions, older adults
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the physical impact of using Hug on both caregivers and care recipients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Basic information
(age, gender, primary disease, medical history)
Motion analysis data
(electromyogram, weight bearing, joint angles, video etc)
Ability assessment
(walking speed, grip, ROM, anthropometry, ADL etc)
Subjective assessment
Nursing care information
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
| Other |
Interventions/Control_1
Transfer assistance using Hug
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
A.Staffs and students who are part of our university
1.Consent to participate in this study
2.Participants whose general condition are stable and who are independent in daily living
3.Participants who are between 140 cm and 180 cm in height and weigh 100 kg or less
B.Nursing staffs who are part of our hospital and collaborative institutions
1.Consent to participate in this study
2.Participants whose general condition are stable and who are able to do perform assistance safely using Hug
C.Outpatients and inpatients from our hospital and collaborative institutions, older adults
1.Consent to participate in this study
2.Participants whose general condition are stable and who are able to stand up safely using Hug
3.Participants who are between 140 cm and 180 cm in height and weigh 100 kg or less
Key exclusion criteria
1.Participants who have requests for exclusion from this research
2.Participants who are judged to be inappropriate by the researcher
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Otaka |
Organization
Fujita Health University
Division name
Department of Rehabilitation Medicine, School of Medicine
Zip code
470-1192
Address
1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
TEL
0562-93-2167
cent-rsh@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Shigeo |
| Middle name | |
| Last name | Tanabe |
Organization
Fujita Health University
Division name
Faculty of Rehabilitation, School of Health Sciences
Zip code
470-1192
Address
1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
TEL
0562-93-9720
Homepage URL
cent-rsh@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Fujita Health University
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
Institutional Review Board of Fujita Health University
Address
1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
Tel
0562-93-2865
f-irb@fujita-hu.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
| 2026 | Year | 07 | Month | 07 | 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
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 06 | Month | 23 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 23 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 07 | Day |
Last follow-up date
| 2029 | 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
| 2026 | Year | 07 | Month | 07 | Day |
Last modified on
| 2026 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000071130
