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Use of Socially Assistive Robots for Long Term Care Older Adults With Cognitive Impairment and Apathy

Impact of a Novel Socially Assistive Robotic Architecture on Engaging Older Adults With Mild Cognitive Impairment, Alzheimer's Disease and Related Dementia in Long Term Care Settings

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05178992
Enrollment
142
Registered
2022-01-05
Start date
2023-02-07
Completion date
2026-01-31
Last updated
2026-05-08

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

Conditions

Alzheimer Disease

Keywords

Apathy, Robotics, Virtual Reality

Brief summary

The objective of this study is to demonstrate the impact of a socially assistive robot system on reducing apathy among cognitively impaired older adults residing in long term care facilities. Earlier phases of this project demonstrated the feasibility and acceptability of the robotic system. First, investigators will improve the social robotic interaction architecture through additional software development, enhance its versatility, and make it easy for non-experts to run. Second, 188 participants will be randomized to either usual activity programs at the long term care facility, or the usual activity programs plus the robotic activities. Researchers will examine the effect on apathy and also plan on examining underlying individual and facility factors that influence the impact of the robotic activities.

Interventions

BEHAVIORALSocially Assistive Robot Activity

Participants will attend two weekly sessions with robot activities. Each session will last 30 minutes. Participants will attend robot sessions for 8 weeks.

Sponsors

Vanderbilt University
Lead SponsorOTHER
National Institute on Aging (NIA)
CollaboratorNIH

Study design

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

Masking description

Trained research assistants separate from other research personnel will collect outcomes; these research personnel will be blinded to the hypotheses and group assignments.

Intervention model description

Participants will be randomized to either Usual Activity Program or Usual Activity Program + Robot Activity within each long term care facility. At each site, the order of the robot type (humanoid or dog) will be randomized. Each participant will participate in two sessions/week for 8 weeks (4 weeks with humanoid robot, 4 weeks with dog robot).

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Residing \>3 months in long term care facility * Evidence of mild cognitive impairment (SAGE score 15-16), mild dementia (SAGE score \<15, AD8\<2, DSRD\<19), or moderate dementia (SAGE \<15, AD8\>1, DSRD 19-36) * Symptoms of apathy (Score 30+ on AES-C)

Exclusion criteria

* Severe cognitive impairment * Physically unable to participate * Unable to provide assent * Uncorrected vision or hearing * Never spoke English * Unable to sit comfortably in chair * Acutely ill, terminally ill or unresponsive * Unable to be moved to activity location * Aggressive or combative

Design outcomes

Primary

MeasureTime frameDescription
Change in ApathyBaseline to Week 8Apathy Evaluation Scale - Clinician (AES-C) will be used to assess changes in composite apathy score from baseline, Week 4, and Week 8. The AES-C is a validated 18-item instrument used to assess cognitive, behavioral, emotional and other symptoms of apathy. Clinicians rate each item based on verbal and nonverbal information provided by the participant. Item scores range from 1 (not at all characteristic) to 4 (a lot characteristic). Total scores range from 18 to 72 where higher derived scores indicate greater apathy.

Secondary

MeasureTime frameDescription
Change in Trail Making Test (TMT)Baseline to Week 8The TMT is a well established test of executive function and has two forms. TMT-A consists of a series of numbers in circles displayed randomly on a page; the person links the numbers in sequence. TMT-B consists of numbers (1 to 13) and letters (A to L) inside circles randomly placed on a page; the person alternates in connecting ascending numbers with ascending letters. TMT is scored by time in seconds to complete, up to 5 minutes. TMT-A normal time is 29 seconds and deficient score is \>78 seconds. TMT-B average score is 75 seconds and deficient score \> 273 seconds.
Change in Animal Fluency TestBaseline to Week 8Verbal fluency tests require verbal ability and executive control processes; the Animal Naming test requires naming 15 animals in 1 minute; thus, less than 15 animals named in 1 minute is considered a deficient score.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 9, 2026