Clinical trial NCT06606600: Impacts of Kebbi Robot Intervention for Older Adults With Mild Dementia
Official title: Impacts of Kebbi Robot Intervention on Cognitive Functions, Heart Rate Variability and Psychological Changes for Older Adults With Mild Dementia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment (MCI)
Keywords: Interactive robot
heart rate variability
psychological changes
dementia
Lead sponsor: National Tainan Junior College of Nursing
Sponsor class: OTHER
First posted: 2024-09-23
Enrollment: 136
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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). 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\&#39; 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: (1) Mini-Mental State Examination (MMSE)
timeFrame: At three time points: before the intervention (T0), immediately the end of the intervention (T1), 1 months after the end-of-intervention (T2).
measure: (2) Montreal Cognitive Assessment (MoCA)
timeFrame: At three time points: before the intervention (T0), immediately the end of the intervention (T1), 1 months after the end-of-intervention (T2).
measure: (3) Finger Tapping Test (FTT)
timeFrame: At three time points: before the intervention (T0), immediately the end of the intervention (T1), 1 months after the end-of-intervention (T2).
measure: (4) Heart rate variability (HRV)
timeFrame: 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:
measure: (5) Geriatric depression scale-short form (GDS-SF)
timeFrame: At three time points: before the intervention (T0), immediately the end of the intervention (T1), 1 months after the end-of-intervention (T2).
measure: (6) the UCLA Loneliness Scale Version 3 (UCLA- Version 3)
timeFrame: At three time points: before the intervention (T0), immediately the end of the intervention (T1), 1 months after the end-of-intervention (T2).
measure: (7) the Friendship scale
timeFrame: At three time points: before the intervention (T0), immediately the end of the intervention (T1), 1 months after the end-of-intervention (T2).
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: Luth Day Care Centre
city: Tainan
country: Taiwan
facility: fuqian Care ceenter
Study officials:
References: