UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046256 |
|---|---|
| Receipt number | R000052771 |
| Scientific Title | Feasibility of evaluating psychological and emotional responses to sensory stimuli in people with dementia : a pilot study |
| Date of disclosure of the study information | 2021/12/01 |
| Last modified on | 2024/06/12 14:08:19 |
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Basic information
Public title
Feasibility of evaluating responses to care support robot for dementia
Acronym
Feasibility of evaluating responses to care support robot for dementia
Scientific Title
Feasibility of evaluating psychological and emotional responses to sensory stimuli in people with dementia : a pilot study
Scientific Title:Acronym
Feasibility of evaluating psychological and emotional responses to sensory stimuli in people with dementia : a pilot study
Region
| Japan |
Condition
Condition
Dementia
Classification by specialty
| Geriatrics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the feasibility of evaluating the psychological and emotional responses to the sensory stimuli given by emotional support robots in people with dementia.
Basic objectives2
Others
Basic objectives -Others
-To clarify the characteristics of quantity and quality of the psychological and emotional responses of people with dementia evoked by the stimulation of different sensory modality.
-Examine the relationship between the characteristics or residual function of the subject and the parameters regarding the response to the stimulus.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Completion rate of presenting robotic stimulation (Ratio of actual stimulus presentation time to planned stimulus presentation time)
Key secondary outcomes
-Subjective evaluation of emotion in receiving robotic stimulation
-Facial expression during robotic stimulation
-Spoken words during robotic stimulation
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Visual, auditory, and light touch stimuli produced by emotional support robots are presented 30 seconds in maximum, respectively.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
-Able to maintain sitting position for 15 minutes or more
-Able to communicate in easy words and to obey two-step commands
-Consent to the implementation of this study
Key exclusion criteria
-Unstable physical or mental condition
-Be evident of higher cognitive dysfunction due to causes other than dementia
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Eri |
| Middle name | |
| Last name | Otaka |
Organization
National Center for Geriatrics and Gerontology
Division name
Assistive Robot Center
Zip code
474-8511
Address
7-430 Morioka-chou, Obu, Aichi
TEL
0562-46-2311
eotaka@ncgg.go.jp
Public contact
Name of contact person
| 1st name | Hiroko |
| Middle name | |
| Last name | Nakamura |
Organization
National Center for Geriatrics and Gerontology
Division name
Assistive Robot Center
Zip code
474-8511
Address
7-430 Morioka-chou, Obu, Aichi
TEL
0562-46-2311
Homepage URL
clinrob@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
Japan Health Research Promotion Bureau
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center for Geriatrics and Gerontology
Address
474-8511 7-430 Morioka-chou, Obu, Aichi
Tel
0562-46-2311
yaday@ncgg.go.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
| 2021 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052771
Publication of results
Published
Result
URL related to results and publications
https://aging.jmir.org/2024/1/e52443
Number of participants that the trial has enrolled
29
Results
The expression intensity value for happy was the largest in both the subjective and objective assessments and increased significantly when all sensory modalities (visual, auditory, and tactile) were presented (median expression intensity 0.21, IQR 0.09-0.35) compared to the other 2 patterns. The comparison of different types of robots revealed a significant increase when all stimuli were presented by doll-type and animal-type robots, but not humanoid-type robots.
Results date posted
| 2024 | Year | 06 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 29 participants (mean age 88.7, SD 6.2 years; n=27 female; Japanese version of Mini-Mental StateExamination mean score 18.2, SD 5.1) were recruited. Eleven participants (38%) had been diagnosed with Alzheimer disease by their physician, 5 (17%) had dementia with Lewy bodies, and 13 (45%) met the criteria for major neurocognitive disorder in the DSM-5, but the etiology was not specified. All the participants had cognitive decline when compared with the cutoff value of 26 on the MoCA-J.
Participant flow
Not applicable (single-arm study)
Adverse events
None
Outcome measures
Expression intensity based on facial expression analysis of facial images
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 09 | Month | 10 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 02 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2022 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 12 | Month | 01 | Day |
Last modified on
| 2024 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052771
