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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dementia; Mild Cognitive Impairment (MCI)
• Intervention / Treatment: Other: interactive robot game

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dorothy Bai, PhD; Phone Number: 6332 +886-2-27361661; Email: dbai@tmu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: interactive robot game; 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; The experimental group will engage in robot games for 12 weeks, twice weekly, about 20 minutes per session
No Intervention: Routine care; The control group will receive routine care and will not undergo any specific interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life in Alzheimer's Disease(QoL-AD)	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.	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)	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.	From baseline to 12 weeks after the intervention, with follow-up assessments at 1 month and 3 months post-intervention.

Collaborators and Investigators

• Sponsor: Taipei Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: November 26, 2025
• First Submitted That Met QC Criteria: November 26, 2025
• First Posted (Estimated): December 9, 2025

Study Record Updates

• Last Update Posted (Estimated): December 9, 2025
• Last Update Submitted That Met QC Criteria: November 26, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; Dementia
• Other Study ID Numbers: N202504063

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No