Impacts of Kebbi Robot Intervention for Older Adults With Mild Dementia

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.

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 Overview

• Status: Completed
• Conditions: Mild Cognitive Impairment (MCI)
• Intervention / Treatment: Other: Intensive Kebbi robot interventions

• Study Type: Interventional
• Enrollment (Actual): 136
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Tainan, Taiwan, 70847
    • fuqian Care ceenter
  • Tainan, Taiwan, 700
    • Luth Day Care Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intensive Kebbi robot interventions; Intensive Kebbi robot interventions will receive 30 minutes, 3 time per week for 12 weeks.	Other: Intensive Kebbi robot interventions; The intensive Kebbi robot interventions will receive 30 minutes, 3 times per week for 12 weeks.
No Intervention: Thc control group; The control group will receive the usual activity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
(1) Mini-Mental State Examination (MMSE)	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)	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)	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)	At three time points: before the intervention (T0), immediately the end of the intervention (T1), 1 months after the end-of-intervention (T2).

Secondary Outcome Measures

Outcome Measure	Time Frame
(5) Geriatric depression scale-short form (GDS-SF)	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)	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	At three time points: before the intervention (T0), immediately the end of the intervention (T1), 1 months after the end-of-intervention (T2).

Collaborators and Investigators

• Sponsor: National Tainan Junior College of Nursing

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2025
• Primary Completion (Actual): July 30, 2025
• Study Completion (Actual): July 30, 2025

Study Registration Dates

• First Submitted: September 18, 2024
• First Submitted That Met QC Criteria: September 20, 2024
• First Posted (Actual): September 23, 2024

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: dementia; heart rate variability; Interactive robot; psychological changes
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; Dementia
• Other Study ID Numbers: NSTC 113-2314-B439-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No