Mild Cognitive Impairment (MCI)NCT06606600
Impacts of Kebbi Robot Intervention for Older Adults With Mild Dementia
A study testing Intensive Kebbi robot interventions in people with Mild Cognitive Impairment (MCI), run by National Tainan Junior College of Nursing at 2 sites in Taiwan.
Trial summary
The goal of this clinical trial is to examine the immediate and sustained effects of an intensive Kebbi robot intervention on cognitive functions, heart rate variability (HRV), and psychological changes for older adults with mild dementia in long-term care (LTC). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Mild Cognitive Impairment (MCI)
- What is being tested?
- Intensive Kebbi robot interventions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 2 sitesTaiwan
- Study dates
- 3 Feb 2025to 30 Jul 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
- No healthy volunteers
- Older adult
Who may be able to join
- aged 65 years or over;
- mild dementia (MMSE score between (19-24) according to level of education;
- an ability to communicate in Mandarin or Taiwanese;
- has been admitted in dementia daycare centers at least 3 months.
Who cannot join
- have severe difficulty in communication;
- are totally dependent on carers for daily activity;
- have a diagnosed infectious disease, moderate or severe dementia, and severe mental illness such as schizophrenia and delusional disorder
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
Luth Day Care Centre
Tainan, 700
fuqian Care ceenter
Tainan, 70847
About this study
Official title: Impacts of Kebbi Robot Intervention on Cognitive Functions, Heart Rate Variability and Psychological Changes for Older Adults With Mild Dementia
The goal of this clinical trial is to examine the immediate and sustained effects of an intensive Kebbi robot intervention on cognitive functions, heart rate variability (HRV), and psychological changes for older adults with mild dementia in long-term care (LTC). The main questions it aims to answer are:
- Are intensive Kebbi robot interventions effective in improving cognitive functions, HRV, and psychological changes for older adults with mild dementia in LTC?
- What are the participants\' experiences and perceptions after intensive Kebbi robot interventions? Researchers will compare intensive Kebbi robot interventions to a control group (receiving usual activity) to see if they are effective in improving cognitive functions, HRV, and psychological changes in older adults with mild dementia in LTC.
Read more
Participants will:
- Participants in the intensive Kebbi robot interventions will receive 30 minutes, thrice weekly, for 12 weeks. Participants in the control group will receive the usual activity.
- The outcome measures will be conducted at three time points: before the intervention (T0), immediately after the end of the intervention (T1), and one month after the end of the intervention (T2).
- Outcome measurements include the cognitive outcomes: Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), Finger Tapping Test (FTT); heart rate variability (HRV); psychological changes: the Geriatric depression scale-short form (GDS-SF), the UCLA Loneliness Scale Version 3 (UCLA- Version 3), and the Friendship scale.
- Conditions
- Mild Cognitive Impairment (MCI)
- Being tested
- Intensive Kebbi robot interventions
- Keywords
- Interactive robot, heart rate variability, psychological changes, dementia
- Medical subject headings
- Cognitive Dysfunction, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive Kebbi robot interventionsOther
The intensive Kebbi robot interventions will receive 30 minutes, 3 times per week for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Intensive Kebbi robot interventions | Experimental | Intensive Kebbi robot interventions will receive 30 minutes, 3 time per week for 12 weeks. Receives: Other: Intensive Kebbi robot interventions |
| Thc control group | No intervention | The control group will receive the usual activity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
(1) Mini-Mental State Examination (MMSE)
Measured: At three time points: before the intervention (T0), immediately the end of the intervention (T1), 1 months after the end-of-intervention (T2).
(2) Montreal Cognitive Assessment (MoCA)
Measured: At three time points: before the intervention (T0), immediately the end of the intervention (T1), 1 months after the end-of-intervention (T2).
(3) Finger Tapping Test (FTT)
Measured: At three time points: before the intervention (T0), immediately the end of the intervention (T1), 1 months after the end-of-intervention (T2).
(4) Heart rate variability (HRV)
Measured: At three time points: before the intervention (T0), immediately the end of the intervention (T1), 1 months after the end-of-intervention (T2).
Secondary outcomes (3)
(5) Geriatric depression scale-short form (GDS-SF)
Measured: At three time points: before the intervention (T0), immediately the end of the intervention (T1), 1 months after the end-of-intervention (T2).
(6) the UCLA Loneliness Scale Version 3 (UCLA- Version 3)
Measured: At three time points: before the intervention (T0), immediately the end of the intervention (T1), 1 months after the end-of-intervention (T2).
(7) the Friendship scale
Measured: At three time points: before the intervention (T0), immediately the end of the intervention (T1), 1 months after the end-of-intervention (T2).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start3 Feb 2025
- Primary completion30 Jul 2025
- Study completion30 Jul 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Tainan Junior College of Nursing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shu-Chuan Chen, National Tainan Junior College of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06606600
- Sponsor's protocol ID
- NSTC 113-2314-B439-001
- Status last verified
- Apr 2026
- First submitted
- 18 Sep 2024
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impacts of Kebbi Robot Intervention on Cognitive Functions, Heart Rate Variability and Psychological Changes for Older Adults With Mild Dementia
- ClinicalTrials.gov ID
- NCT06606600
- Acronym / sponsor ID
- NSTC 113-2314-B439-001
- Conditions
- Mild Cognitive Impairment (MCI)
- Keywords
- Interactive robot, heart rate variability, psychological changes, dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- National Tainan Junior College of NursingUniversity, hospital or other
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 23 Sep 2024 (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 goal of this clinical trial is to examine the immediate and sustained effects of an intensive Kebbi robot intervention on cognitive functions, heart rate variability (HRV), and psychological changes for older adults with mild dementia in long-term care (LTC). The main questions it aims to answer are:
- Are intensive Kebbi robot interventions effective in improving cognitive functions, HRV, and psychological changes for older adults with mild dementia in LTC?
- What are the participants\' experiences and perceptions after intensive Kebbi robot interventions? Researchers will compare intensive Kebbi robot interventions to a control group (receiving usual activity) to see if they are effective in improving cognitive functions, HRV, and psychological changes in older adults with mild dementia in LTC.
Participants will:
- Participants in the intensive Kebbi robot interventions will receive 30 minutes, thrice weekly, for 12 weeks. Participants in the control group will receive the usual activity.
- The outcome measures will be conducted at three time points: before the intervention (T0), immediately after the end of the intervention (T1), and one month after the end of the intervention (T2).
- Outcome measurements include the cognitive outcomes: Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), Finger Tapping Test (FTT); heart rate variability (HRV); psychological changes: the Geriatric depression scale-short form (GDS-SF), the UCLA Loneliness Scale Version 3 (UCLA- Version 3), and the Friendship scale.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive Kebbi robot interventions | Experimental | Other: Intensive Kebbi robot interventionsIntensive Kebbi robot interventions will receive 30 minutes, 3 time per week for 12 weeks. |
| Thc control group | No intervention | –The control group will receive the usual activity. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- aged 65 years or over;
- mild dementia (MMSE score between (19-24) according to level of education;
- an ability to communicate in Mandarin or Taiwanese;
- has been admitted in dementia daycare centers at least 3 months.
Key exclusion criteria (3 listed)
- have severe difficulty in communication;
- are totally dependent on carers for daily activity;
- have a diagnosed infectious disease, moderate or severe dementia, and severe mental illness such as schizophrenia and delusional disorder
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 |
|---|---|---|
| Intensive Kebbi robot interventionsThe intensive Kebbi robot interventions will receive 30 minutes, 3 times per week for 12 weeks. | Other | Intensive Kebbi robot interventions |
Primary outcome
(1) Mini-Mental State Examination (MMSE)
Time frame: At three time points: before the intervention (T0), immediately the end of the intervention (T1), 1 months after the end-of-intervention (T2).
(2) Montreal Cognitive Assessment (MoCA)
Time frame: At three time points: before the intervention (T0), immediately the end of the intervention (T1), 1 months after the end-of-intervention (T2).
(3) Finger Tapping Test (FTT)
Time frame: At three time points: before the intervention (T0), immediately the end of the intervention (T1), 1 months after the end-of-intervention (T2).
(4) Heart rate variability (HRV)
Time frame: At three time points: before the intervention (T0), immediately the end of the intervention (T1), 1 months after the end-of-intervention (T2).
3 secondary outcomes
(5) Geriatric depression scale-short form (GDS-SF)
Time frame: At three time points: before the intervention (T0), immediately the end of the intervention (T1), 1 months after the end-of-intervention (T2).
(6) the UCLA Loneliness Scale Version 3 (UCLA- Version 3)
Time frame: At three time points: before the intervention (T0), immediately the end of the intervention (T1), 1 months after the end-of-intervention (T2).
(7) the Friendship scale
Time frame: At three time points: before the intervention (T0), immediately the end of the intervention (T1), 1 months after the end-of-intervention (T2).
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 24 Apr 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive Kebbi robot interventions in people with Mild Cognitive Impairment (MCI), run by National Tainan Junior College of Nursing at 2 sites 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 4 inclusion and 3 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 24 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 2 sites 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?
(1) Mini-Mental State Examination (MMSE) (time frame: At three time points: before the intervention (T0), immediately the end of the intervention (T1), 1 months after the end-of-intervention (T2).). The study lists 4 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 24 Apr 2026.