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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-100
SponsorTaipei Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • interactive robot game

    Other intervention

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

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: interactive robot gameExperimental treatment 1 intervention
Group B: Routine careNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
From baseline to 12 weeks after the intervention, with follow-up assessments at 1 month and 3 months post-intervention.
2

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.

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

Secondary outcomes

1

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.

Time frame
From baseline to 12 weeks after the intervention, with follow-up assessments at 1 month and 3 months post-intervention.
2

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.

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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