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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07272746
Enrollment
200
Registered
2025-12-09
Start date
2025-12-31
Completion date
2026-12-31
Last updated
2025-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia, Mild Cognitive Impairment (MCI)

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.

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

OTHERinteractive robot game

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

Sponsors

Taipei Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
50 Years to 100 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Montreal Cognitive Assessment(MoCA)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.
Neuropsychiatric Inventory Questionnaire(NPI-Q)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

MeasureTime frameDescription
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.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.
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.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.

Contacts

Primary ContactDorothy Bai, PhD
dbai@tmu.edu.tw+886-2-27361661

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026