Impacts of Kebbi Robot Intervention for Older Adults With Mild Dementia

NCT ID: NCT06606600

Last Updated: 2025-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-03

Study Completion Date

2025-07-30

Brief Summary

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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.

Detailed Description

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Conditions

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Mild Cognitive Impairment (MCI)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Intensive Kebbi robot interventions

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

Group Type EXPERIMENTAL

Intensive Kebbi robot interventions

Intervention Type OTHER

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

Thc control group

The control group will receive the usual activity.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Intensive Kebbi robot interventions

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Tainan Junior College of Nursing

OTHER

Sponsor Role lead

Responsible Party

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Shu-Chuan Chen

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Luth Day Care Centre

Tainan City, , Taiwan

Site Status RECRUITING

fuqian Care ceenter

Tainan City, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Shu-Chuan Chen, Ph.D

Role: CONTACT

886-211-0900

Facility Contacts

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Huang Chunyi Huang

Role: primary

06-3584707

Luo

Role: primary

Other Identifiers

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NSTC 113-2314-B439-001

Identifier Type: -

Identifier Source: org_study_id

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