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

NCT07272746 | Not Yet Recruiting

• 1 other identifier: N202504063
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Dementia; Mild Cognitive Impairment (MCI)

Outcome Measures

Primary Outcomes (2)

• Montreal Cognitive Assessment(MoCA)

  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.

  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)

  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.

  From baseline to 12 weeks after the intervention, with follow-up assessments at 1 month and 3 months post-intervention.

Secondary Outcomes (2)

• Quality of Life in Alzheimer's Disease(QoL-AD)

  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)

  From baseline to 12 weeks after the intervention, with follow-up assessments at 1 month and 3 months post-intervention.

Study Arms (2)

interactive robot game

EXPERIMENTAL

The experimental group will participate in a 12-week interactive robot game. The interactive robot is a screen-based robot, with the main interaction area being a facial display.

Other: interactive robot game

Routine care

NO INTERVENTION

The control group will receive routine care and will not undergo any specific interventions

Interventions

interactive robot game OTHER

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

interactive robot game

Eligibility Criteria

• Age: 50 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Medical University: lead

MeSH Terms

Conditions

Dementia; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Dorothy Bai, PhD

CONTACT

+886-2-27361661; dbai@tmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 9, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 9, 2025

Record last verified: 2025-11