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Social Robot Interaction for Cognitive Impairment

Phase 1 & 2

Recruiting

Research Sponsored by Vanderbilt University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Residing >3 months in long term care facility

Be older than 65 years old

Must not have

Unable to provide assent

Physically unable to participate

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to week 8

Awards & highlights

No Placebo-Only Group

Summary

This trial will improve a social robotic interaction system to make it more versatile and easy to use, then test it with 188 cognitively impaired older adults in long term care facilities to see if it reduces apathy.

Who is the study for?

This trial is for older adults with mild to moderate cognitive impairment and apathy, living in long-term care for over 3 months. Participants should have certain scores on cognitive tests (SAGE, AD8, DSRD) and show symptoms of apathy (AES-C score of 30+). It's not suitable for those with severe cognitive issues, physical limitations that prevent participation, sensory impairments without correction, non-English speakers or those who are acutely or terminally ill.

What is being tested?

The study aims to see if a socially assistive robot can help reduce apathy in cognitively impaired seniors. The project involves software enhancements to the robot system followed by a comparison between usual activities versus usual activities plus interaction with the robotic system among 188 participants randomly assigned to each group.

What are the potential side effects?

Since this intervention involves social interaction with a robot rather than medication or invasive procedures, traditional side effects are not expected. However, there may be psychological impacts such as frustration or lack of interest which will be monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have lived in a long-term care facility for more than 3 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am unable to give my consent.

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I am physically unable to take part in activities.

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I cannot move to different places on my own.

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I have never spoken English.

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I have significant memory or thinking problems.

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I cannot sit comfortably in a chair.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 8

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to week 8

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 8 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Apathy

Secondary study objectives

Glycogen

Change in Trail Making Test (TMT)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Socially Assistive Robot ActivityExperimental Treatment1 Intervention

Participants will attend two sessions per week and interact with the robot. Four weeks with a humanoid robot and four weeks with a dog robot. Participants can continue to join other activities held within the facility.

Group II: Usual Activity ProgramActive Control1 Intervention

Participants will attend at least two sessions per week at activities held within the facility. They will not be exposed to the robot activities.

0 / 7Eligibility criteria met