Impacts of Kebbi Robot Intervention for Older Adults With Mild Dementia

NCT06606600 | Completed

• 1 other identifier: NSTC 113-2314-B439-001
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 2

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\' 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.

Conditions

Mild Cognitive Impairment (MCI)

Keywords

Interactive robot; heart rate variability; psychological changes; dementia

Outcome Measures

Primary Outcomes (4)

• (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 Outcomes (3)

• (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).

Study Arms (2)

Intensive Kebbi robot interventions

EXPERIMENTAL

Intensive Kebbi robot interventions will receive 30 minutes, 3 time per week for 12 weeks.

Other: Intensive Kebbi robot interventions

Thc control group

NO INTERVENTION

The control group will receive the usual activity.

Interventions

Intensive Kebbi robot interventions OTHER

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

Intensive Kebbi robot interventions

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Tainan Junior College of Nursing: lead

Study Sites (2)

Luth Day Care Centre

Tainan, 700, Taiwan

Location

fuqian Care ceenter

Tainan, 70847, Taiwan

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Dementia

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: September 18, 2024
• First Posted: September 23, 2024
• Study Start: February 3, 2025
• Primary Completion: July 30, 2025
• Study Completion: July 30, 2025
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)