Mild Cognitive Impairment (MCI)NCT06984458
Exploring the Impact of Dementia Prevention Programs Using Robots as Intervention Tools on Community Elderly
A study testing Robot Dementia Prevention Course in people with Mild Cognitive Impairment (MCI) and Dementia, run by National Taiwan Normal University at 1 site in Taiwan.
Trial summary
The purpose of this study is to intervene in the cognitive functions of the community elderly through the "Robot Dementia Prevention Course" training. It is expected that through the eight-week course design activities, the cognitive functions, social activities, emotional management (such as alleviating depression)… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment (MCI), Dementia, Cognitive Decline
- What is being tested?
- Robot Dementia Prevention Course
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 18 Apr 2025to 21 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age 65 years or older, Able to communicate in Mandarin or Taiwanese, Able to provide informed consent or have a legal guardian provide consent
Who cannot join
- Diagnosis of severe dementia or advanced neurodegenerative disease, Severe psychiatric disorders (e.g., schizophrenia, bipolar disorder), Unconsciousness or inability to stay awake or focused for the session duration, Inability to comply with study protocol or scheduled sessions
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to intervene in the cognitive functions of the community elderly through the "Robot Dementia Prevention Course" training. It is expected that through the eight-week course design activities, the cognitive functions, social activities, emotional management (such as alleviating depression), well-being, reduce loneliness and can be achieved, thereby preventing or delaying cognitive decline.
This study is a quasi-experimental design. It adopts pre-test and post-test methods for the experimental group and the control group. Before the intervention of the "Robotic Dementia Prevention Course", the community elderly were given a pre-test. After receiving an 8-week course (two months), the first post-test will be conducted, and three months later, the second post-test (post-post-test) will be conducted to analyze the delay effect. The experimental group conducted a two-month "Robot Dementia Prevention Course" intervention. The research subjects were 40 people. Each group of 5 people was assigned a Kebbi robot. The course intervention was divided into 8 groups. The Kebbi robot mainly taught and communicated with the elderly interactively. There is a well-trained teaching assistant in the class to enhance the learning effect of the elderly. The two classes per week are about 2 hours long, with 50 minutes of course knowledge introduction, 10 minutes of rest, 50 minutes of interaction with Kebbi Artificial Intelligence-based board games, and 10 minutes of prize-based quizzes after class. They are held once a week, with a total of 8 weeks of courses (duration two months), classes were taken in the elderly's original care center or long-term care base; the control group did not receive any course intervention. Statistical methods were analyzed using SPSS version 23.0, and descriptive statistics, paired t tests, generalized estimating equations, etc. were used to test the changes before and after the intervention.
- Conditions
- Mild Cognitive Impairment (MCI), Dementia, Cognitive Decline, Psychological Well-being, Aging and Cognitive Health
- Being tested
- Robot Dementia Prevention Course
- Keywords
- Robot-delivery intervention, Dementia prevention, Dementia, Community elderly
- Medical subject headings
- Cognitive Dysfunction, Dementia, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot Dementia Prevention CourseBehavioural
It is expected that through the eight-week course design activities, the cognitive functions, social activities, emotional management (such as alleviating depression), well-being, reduce loneliness and can be achieved, thereby preventing or delaying cognitive decline.
The experimental group conducted a two-month "Robot Dementia Prevention Course" intervention. The research subjects were 40 people. Each group of 5 people was assigned a Kebbi robot. The course intervention was divided into 8 groups. The Kebbi robot mainly taught and communicated with the elderly interactively. There is a well-trained teaching assistant in the class to enhance the learning effect of the elderly. The two classes per week are about 2 hours long, with 50 minutes of course knowledge introduction, 10 minutes of rest, 50 minutes of interaction with Kebbi Artificial Intelligence-based board games, and 10 minutes of prize-based quizzes after class.
| Study group | Role | What they receive |
|---|---|---|
| Dementia Prevention Programs Using Robots as Intervention Tools | Experimental | The experimental group conducted a two-month "Robot Dementia Prevention Course" intervention. The research subjects were 40 people. Each group of 5 people was assigned a Kebbi robot. The course intervention was divided into 8 groups. The Kebbi robot mainly taught and communicated with the elderly interactively. There is a well-trained teaching assistant in the class to enhance the learning effect of the elderly. The two classes per week are about 2 hours long, with 50 minutes of course knowledge introduction, 10 minutes of rest, 50 minutes of interaction with Kebbi Artificial Intelligence-based board games, and 10 minutes of prize-based quizzes after class. They are held once a week, with a total of 8 weeks of courses (duration two months). Receives: Behavioral: Robot Dementia Prevention Course |
| Control group | No intervention | The control group did not receive any course intervention. The community elderly were given a pre-test. After 8 weeks (two months), the f post-test will be conducted. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cognitive Function Assessed by SPMSQ
Measured: Participants will complete the SPMSQ at baseline, post-intervention (week 8), and follow-up (week 20).
Change in Depression Symptoms Assessed by GDS-15
Measured: The instrument will be administered at baseline, post-intervention (week 8), and follow-up (week 20).
Change in Social Engagement and Activities Assessed by SEAQ
Measured: The instrument will be administered at baseline, post-intervention (week 8), and follow-up (week 20).
Change in Psychological Well-being Assessed by WHO-5
Measured: The instrument will be administered at baseline, post-intervention (week 8), and follow-up (week 20).
Change in loneliness Assessed by UCLA Loneliness Scale
Measured: The instrument will be administered at baseline, post-intervention (week 8), and follow-up (week 20).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start18 Apr 2025
- Primary completion15 Oct 2025
- Study completion21 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive Impairment (MCI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan Normal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jong-Long Guo, PhD, Study chair, National Taiwan Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06984458
- Sponsor's protocol ID
- 202503HM004
- Status last verified
- Apr 2026
- First submitted
- 14 May 2025
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Impact of Dementia Prevention Programs Using Robots as Intervention Tools on Community Elderly
- ClinicalTrials.gov ID
- NCT06984458
- Acronym / sponsor ID
- 202503HM004
- Conditions
- Mild Cognitive Impairment (MCI), Dementia, Cognitive Decline, Psychological Well-being, Aging and Cognitive Health
- Keywords
- Robot-delivery intervention, Dementia prevention, Dementia, Community elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- National Taiwan Normal UniversityUniversity, hospital or other
- Study start
- 18 Apr 2025 (actual)
- Primary completion
- 15 Oct 2025 (actual)
- Study completion
- 21 Nov 2025 (actual)
- First posted
- 22 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to intervene in the cognitive functions of the community elderly through the "Robot Dementia Prevention Course" training. It is expected that through the eight-week course design activities, the cognitive functions, social activities, emotional management (such as alleviating depression), well-being, reduce loneliness and can be achieved, thereby preventing or delaying cognitive decline.
This study is a quasi-experimental design. It adopts pre-test and post-test methods for the experimental group and the control group. Before the intervention of the "Robotic Dementia Prevention Course", the community elderly were given a pre-test. After receiving an 8-week course (two months), the first post-test will be conducted, and three months later, the second post-test (post-post-test) will be conducted to analyze the delay effect. The experimental group conducted a two-month "Robot Dementia Prevention Course" intervention. The research subjects were 40 people. Each group of 5 people was assigned a Kebbi robot. The course intervention was divided into 8 groups. The Kebbi robot mainly taught and communicated with the elderly interactively. There is a well-trained teaching assistant in the class to enhance the learning effect of the elderly. The two classes per week are about 2 hours long, with 50 minutes of course knowledge introduction, 10 minutes of rest, 50 minutes of interaction with Kebbi Artificial Intelligence-based board games, and 10 minutes of prize-based quizzes after class. They are held once a week, with a total of 8 weeks of courses (duration two months), classes were taken in the elderly's original care center or long-term care base; the control group did not receive any course intervention. Statistical methods were analyzed using SPSS version 23.0, and descriptive statistics, paired t tests, generalized estimating equations, etc. were used to test the changes before and after the intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dementia Prevention Programs Using Robots as Intervention Tools | Experimental | Behavioral: Robot Dementia Prevention CourseThe experimental group conducted a two-month "Robot Dementia Prevention Course" intervention. The research subjects were 40 people. Each group of 5 people was assigned a Kebbi robot. The course intervention was divided into 8 groups. The Kebbi robot mainly taught and communicated with the elderly interactively. There is a well-trained teaching assistant in the class to enhance the learning effect of the elderly. The two classes per week are about 2 hours long, with 50 minutes of course knowledge introduction, 10 minutes of rest, 50 minutes of interaction with Kebbi Artificial Intelligence-based board games, and 10 minutes of prize-based quizzes after class. They are held once a week, with a total of 8 weeks of courses (duration two months). |
| Control group | No intervention | –The control group did not receive any course intervention. The community elderly were given a pre-test. After 8 weeks (two months), the f post-test will be conducted. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Age 65 years or older, Able to communicate in Mandarin or Taiwanese, Able to provide informed consent or have a legal guardian provide consent
Key exclusion criteria (1 listed)
- Diagnosis of severe dementia or advanced neurodegenerative disease, Severe psychiatric disorders (e.g., schizophrenia, bipolar disorder), Unconsciousness or inability to stay awake or focused for the session duration, Inability to comply with study protocol or scheduled sessions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robot Dementia Prevention CourseIt is expected that through the eight-week course design activities, the cognitive functions, social activities, emotional management (such as alleviating depression), well-being, reduce loneliness and can be achieved, thereby preventing or delaying cognitive decline. The experimental group conducted a two-month "Robot Dementia Prevention Course" intervention. The research subjects were 40 people. Each group of 5 people was assigned a Kebbi robot. The course intervention was divided into 8 groups. The Kebbi robot mainly taught and communicated with the elderly interactively. There is a well-trained teaching assistant in the class to enhance the learning effect of the elderly. The two classes per week are about 2 hours long, with 50 minutes of course knowledge introduction, 10 minutes of rest, 50 minutes of interaction with Kebbi Artificial Intelligence-based board games, and 10 minutes of prize-based quizzes after class. | Behavioural | Dementia Prevention Programs Using Robots as Intervention Tools |
Primary outcome
Change in Cognitive Function Assessed by SPMSQ
Time frame: Participants will complete the SPMSQ at baseline, post-intervention (week 8), and follow-up (week 20).
Change in Depression Symptoms Assessed by GDS-15
Time frame: The instrument will be administered at baseline, post-intervention (week 8), and follow-up (week 20).
Change in Social Engagement and Activities Assessed by SEAQ
Time frame: The instrument will be administered at baseline, post-intervention (week 8), and follow-up (week 20).
Change in Psychological Well-being Assessed by WHO-5
Time frame: The instrument will be administered at baseline, post-intervention (week 8), and follow-up (week 20).
Change in loneliness Assessed by UCLA Loneliness Scale
Time frame: The instrument will be administered at baseline, post-intervention (week 8), and follow-up (week 20).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jong-Long Guo, PhD study chair
National Taiwan Normal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot Dementia Prevention Course in people with Mild Cognitive Impairment (MCI) and Dementia, run by National Taiwan Normal University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cognitive Function Assessed by SPMSQ (time frame: Participants will complete the SPMSQ at baseline, post-intervention (week 8), and follow-up (week 20).). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.