UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062356 |
|---|---|
| Receipt number | R000071369 |
| Scientific Title | Feasibility of Social Robot Intervention for Older Adults Living Alone: A Pilot Study |
| Date of disclosure of the study information | 2026/07/27 |
| Last modified on | 2026/07/27 23:40:12 |
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Basic information
Public title
Social Robot Study for Older Adults Living Alone
Acronym
SoRo-LA Study
Scientific Title
Feasibility of Social Robot Intervention for Older Adults Living Alone: A Pilot Study
Scientific Title:Acronym
SoRo-LA Study
Region
| Japan |
Condition
Condition
Older people living alone
Classification by specialty
| Geriatrics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to confirm the feasibility of promoting active engagement with social robots among older adults living alone, and to conduct an exploratory examination of changes in their physical activity levels and subjective well-being.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Physical Activity
Subjective Well-being (World Health Organization-Five Well-Being Index)
Key secondary outcomes
Loneliness (The Three-Item Loneliness Scale; TIL-scale)
Depression (Geriatric Depression Scale 5)
Frailty (Basic Checklist)
Frequency of going out (Life-Space Assessment)
questionnaire (regarding interaction with the social robot)
Demographic characteristics: age, gender, height, weight, family composition, comorbidities, educational background, cognitive function (Mini-Cog)
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
| Behavior,custom |
Interventions/Control_1
Social robots will be loaned to participant homes. The robot used is NICOBO (manufactured by Panasonic). NICOBO is a social robot characterized by its ability to engage in continuous social interaction with people through voice communication, emotional expression, and responses to physical contact. As part of the intervention, participants are encouraged to actively engage with the robot in their daily lives for example, by speaking to it or touching it but no restrictions are placed on the specific frequency or methods of use, as the focus is on voluntary engagement. The intervention period is four weeks.
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
Older people aged 65 and older who live alone
Key exclusion criteria
Individuals suspected of having cognitive decline (Mini-Cog score of 2 or less)
Individuals who own a pet
Individuals with a pacemaker
Individuals deemed unable to understand the study or provide informed consent
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yumi |
| Middle name | |
| Last name | Higuchi |
Organization
Osaka Metropolitan University
Division name
Graduate School of Rehabilitation Science
Zip code
536-8525
Address
2-1-132 Morinomiya, Joto-ku, Osaka-shi, Osaka 536-8525, Japan
TEL
06-6167-1261
Higu_reha@omu.ac.jp
Public contact
Name of contact person
| 1st name | Gen |
| Middle name | |
| Last name | Idota |
Organization
Osaka Metropolitan University
Division name
Graduate School of Rehabilitation Science
Zip code
536-8525
Address
2-1-132 Morinomiya, Joto-ku, Osaka-shi, Osaka 536-8525, Japan
TEL
06-6167-1261
Homepage URL
sm26024j@st.omu.ac.jp
Sponsor or person
Institute
Osaka Metropolitan University
Institute
Department
Personal name
Funding Source
Organization
Other
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Committee on Research Ethics of the the Graduate School of Rehabilitation Science, Osaka Metropolitan University
Address
2-1-132 Morinomiya, Joto-ku, Osaka-shi, Osaka 536-8525, Japan
Tel
06-6167-1261
gr-mrny-reha-rinri@omu.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 | 27 | 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
| 2026 | Year | 07 | Month | 23 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 23 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 27 | Day |
Last follow-up date
| 2026 | Year | 12 | 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 | 27 | Day |
Last modified on
| 2026 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071369
