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临床试验/NCT06606600
NCT06606600已完成不适用

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

National Tainan Junior College of Nursing2 个研究点 分布在 1 个国家目标入组 136 人开始时间: 2025年2月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
136
试验地点
2
主要终点
(1) Mini-Mental State Examination (MMSE)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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

研究组 & 干预措施

Intensive Kebbi robot interventions

Experimental

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

干预措施: Intensive Kebbi robot interventions (Other)

Thc control group

No Intervention

The control group will receive the usual activity.

结局指标

主要结局

(1) Mini-Mental State Examination (MMSE)

时间窗: 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)

时间窗: 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)

时间窗: 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)

时间窗: At three time points: before the intervention (T0), immediately the end of the intervention (T1), 1 months after the end-of-intervention (T2).

次要结局

  • (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).)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shu-Chuan Chen

Assistant professor

National Tainan Junior College of Nursing

研究点 (2)

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