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NCT Number: NCT07272746

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

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.

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Key information

Conditions

Dementia Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Mental Disorders Mild Cognitive Impairment (MCI) Nervous System Diseases Neurocognitive Disorders

Age range

50 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

interactive robot game

Other

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

Primary outcomes

  1. 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.

    MoCA is one of the primary assessment indicators that investigators expect to see improved after interactive robot game interventions. The MoCA assessment covers multiple cognitive domains including attention and concentration, executive function, memory, language ability, visuospatial skills, abstract thinking, calculation ability, and orientation. The full score is 30 points, with higher scores indicating better cognitive function.

  2. 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.

    NPI-Q is one of the primary evaluation indicators investigators expect to improve after interactive robot game intervention.

    NPI-Q includes 12 items: delusions, hallucinations, agitation, depression, anxiety, abnormal motor behavior, sleep and nighttime behavior disorders, etc. Each item is scored for severity on a scale of 1-3 points, with higher scores indicating greater severity, and for caregiver distress on a scale of 0-5 points, with higher scores indicating greater distress. The total score is calculated by multiplying the severity and distress scores, with higher scores representing more severe symptoms.

Secondary outcomes

  1. 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.

    Quality of life is one of the secondary outcome measures that investigators expect to improve after an interactive robot game intervention. The QoL-AD scale is rated by the person with dementia and their caregiver on a four-point scale (poor, fair, good, very good) for each item, with total scores ranging from 13 to 52 points, where higher scores indicate better quality of life.

  2. 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.

    The Geriatric Depression Scale-15 (GDS-15) is one of the secondary evaluation indicators that investigators hope will show improvement after an interactive robot game intervention. The GDS-15 is a self-administered assessment scale containing 15 items, with a total score ranging from 0 to 15 points, where higher scores indicate a greater tendency toward depression.

Study contacts

Contact information is provided by the study sponsor or research team.

Dorothy Bai, PhD

CONTACT

[email protected]

+886-2-27361661 ext. 6332

Sponsors and collaborators

Lead sponsor

Taipei Medical University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 9, 2025
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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