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NCT Number: NCT06606600

Impacts of Kebbi Robot Intervention 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.

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.

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Key information

Conditions

Mild Cognitive Impairment (MCI) Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Luth Day Care Centre, Tainan, Taiwan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intensive Kebbi robot interventions

Other

The intensive Kebbi robot interventions will receive 30 minutes, 3 times per week for 12 weeks.

Primary outcomes

  1. (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. (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. (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. (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).

Secondary outcomes

  1. (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).

  2. (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).

  3. (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).

Sponsors and collaborators

Lead sponsor

National Tainan Junior College of Nursing

Other

Registry information

Official study title

Impacts of Kebbi Robot Intervention on Cognitive Functions, Heart Rate Variability and Psychological Changes for Older Adults With Mild Dementia

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 23, 2024
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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