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Not yet recruiting NCT07272746

Effects of a Social Robot Cognitive-Game Intervention in Older Adults With Mild Cognitive Impairment and Dementia

No phase Interventional Dementia Mild Cognitive Impairment (MCI)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: interactive robot game.
Who it may be relevant to
Registry conditions: Dementia, Mild Cognitive Impairment (MCI). Basic parameters: 50 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

This study aims to evaluate the effects of interactive robot-based games on cognitive function, neuropsychiatric symptoms, and quality of life in patients with mild cognitive impairment and dementia. The investigators plan to recruit 80 participants and randomly assign them to a control group or an experimental group; the experimental group will participate in robot games for 12 weeks, while the control group will receive routine care. Data will be collected via questionnaires to investigate whether robot games can improve cognitive function, neuropsychiatric symptoms, and quality of life in patients with mild cognitive impairment and dementia.

Detailed description

This study aims to evaluate the effects of interactive robot games on cognitive function, behavioral and psychological symptoms, and quality of life in patients with mild cognitive impairment and dementia. The investigators plan to recruit 80 participants and randomly assign them to a control group or an experimental group. The experimental group will engage in robot games for 12 weeks, twice weekly, about 20 minutes per session, while the control group will receive usual care. All participants will complete four questionnaire assessments to investigate whether the robot games can improve cognitive function, behavioral and psychological symptoms, and quality of life in patients with mild cognitive impairment and dementia.

Interventions

  • Other interactive robot game
    The experimental group will engage in robot games for 12 weeks, twice weekly, about 20 minutes per session

Primary outcome measures

  • Montreal Cognitive Assessment(MoCA) [Time frame: From baseline to 12 weeks after the intervention, with follow-up assessments at 1 month and 3 months post-intervention.]
  • Neuropsychiatric Inventory Questionnaire(NPI-Q) [Time frame: From baseline to 12 weeks after the intervention, with follow-up assessments at 1 month and 3 months post-intervention.]
Secondary outcome measures (2)
  • Quality of Life in Alzheimer's Disease(QoL-AD) [Time frame: From baseline to 12 weeks after the intervention, with follow-up assessments at 1 month and 3 months post-intervention.]
  • Geriatric Depression Scale 15(GDS-15) [Time frame: From baseline to 12 weeks after the intervention, with follow-up assessments at 1 month and 3 months post-intervention.]

Eligibility criteria

Inclusion criteria

  • Aged 50 years or older
  • Diagnosed by a physician with Mild Cognitive Impairment, mild, or moderate dementia
  • Able to communicate in Mandarin or Taiwanese
  • Willing to participate and provides informed consent signed by the participant or their family member/legal representative

Exclusion criteria

  • Individuals who experience fear or aversion toward interactive robots or related equipment
  • Individuals with severe hearing or visual impairments that affect participation in activities
  • Individuals unable to complete the entire intervention due to unstable physical or mental conditions
  • Individuals deemed unsuitable for this study by physician assessment

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07272746 · N202504063

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗