Social Robot Interaction for Cognitive Impairment

Overseen By Kelley Colopietro, BS

Age: 65+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Vanderbilt University

Disqualifiers: Severe cognitive impairment, Aggressive, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 16

Duration: 8 weeks

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a friendly robot can reduce apathy (a lack of interest or emotion) in older adults with mild to moderate cognitive impairment living in long-term care facilities. Participants will engage with either a humanoid or dog-like robot in activity sessions, while another group will continue their usual activities without robots. Researchers will compare the two groups to determine if the robots improve engagement and interest levels. This study is ideal for individuals who have lived in a care facility for more than three months, show mild to moderate cognitive issues, and experience noticeable apathy. As a Phase 1, Phase 2 trial, this research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking research.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this socially assistive robot system is safe for cognitively impaired older adults?

Research shows that socially assistive robots are being explored to help people with memory and thinking problems, such as those seen in dementia. Various studies have tested these robots, yielding encouraging results. Past research demonstrated that these robots helped reduce feelings of apathy—meaning a lack of interest or enthusiasm—in older adults, suggesting they can engage people positively.

So far, studies have not identified any serious safety issues with these robots. Participants generally respond well to them. The robots interact in a friendly and supportive manner, making them suitable for long-term care settings. As this trial begins, it aims to test the effectiveness and safety of the robots. While no major safety problems have been found so far, the study will monitor for potential risks as more people use the robots.

Overall, current research suggests that using socially assistive robots is safe. Participants can expect a positive experience with these robots, which are designed to improve social interaction and reduce apathy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Socially Assistive Robot Activity because it offers a novel approach to managing cognitive impairment. Unlike traditional treatments that might involve medication or human-led therapy, this method uses interactive robots to engage participants. The unique aspect is the combination of humanoid and dog robots, which could provide diverse social interactions and mental stimulation. This innovative approach aims to enhance cognitive function and quality of life in a way that current treatments may not fully address.

What evidence suggests that this socially assistive robot activity is effective for reducing apathy in cognitively impaired older adults?

Research has shown that socially assistive robots (SARs) can help reduce symptoms like depression and anxiety in people with dementia. Studies have found that interacting with these robots can bring happiness and positive feelings. For people with Alzheimer's, SARs have supported daily activities and improved social interactions. Reviews of multiple studies indicate that these robots significantly reduce anxiety and restlessness, although they don't seem to improve thinking skills. In this trial, participants in the "Socially Assistive Robot Activity" arm will interact with either a humanoid robot or a dog robot, which may help reduce lack of interest among older adults with memory and thinking problems. Meanwhile, participants in the "Usual Activity Program" arm will engage in regular activities without robot interaction. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

You have experienced memory or thinking problems, based on test scores.

You have severe apathy symptoms, as indicated by a score of 30 or higher on a specific test.

Exclusion Criteria

I am unable to give my consent.

I am physically unable to take part in activities.

I cannot move to different places on my own.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either usual activity programs or usual activity programs plus robotic activities, attending two sessions per week for eight weeks

8 weeks

16 visits (in-person)

Follow-up

Participants are monitored for changes in apathy and cognitive function using various assessments

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Socially Assistive Robot Activity

Trial Overview 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.

How Is the Trial Designed?

Group I: Socially Assistive Robot Activity Experimental Treatment 1 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 Program Active Control 1 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.

Who Is Running the Clinical Trial?

Vanderbilt University

Lead Sponsor

Trials

714

Recruited

6,143,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

A LEGO Mindstorms NXT® robot was developed to assist elderly individuals in maintaining healthy life habits through physical and mental activities, showing promise in enhancing their quality of life.

Testing with a group of elderly residents indicated high satisfaction, with scores above 4 out of 5 in all categories of a questionnaire, suggesting the robot's effectiveness in delivering coaching for physical activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Caregiver and social assistant robot for rehabilitation and coaching for the elderly. Pérez, PJ., Garcia-Zapirain, B., Mendez-Zorrilla, A.[2016]

The SAR-Connect platform enhances social interaction among older adults by integrating a humanoid robot with virtual reality activities, allowing for multi-domain engagement that includes physical, cognitive, and social stimuli.

A laboratory study demonstrated that SAR-Connect can effectively involve multiple older adults in activities, promote human-human interaction, and quantify engagement through various sensory responses, indicating its potential as a valuable tool in long-term care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SAR-Connect: A Socially Assistive Robotic System to Support Activity and Social Engagement of Older Adults. Fan, J., Mion, LC., Beuscher, L., et al.[2023]

A study involving 25 participants, including older adults with Mild Cognitive Impairment and their caregivers, found that while there is a recognized potential for Socially Assistive Robots (SAR) to support home care, current acceptance is lower than anticipated for the future.

Key barriers to SAR adoption include mismatches between the robot's capabilities and user needs, usability issues, and a lack of experience with technology, highlighting the need for customization in SAR design to enhance acceptance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Are we ready for robots that care for us?" Attitudes and opinions of older adults toward socially assistive robots. Pino, M., Boulay, M., Jouen, F., et al.[2022]

Social robotics focuses on creating robots that engage in caring interactions with people, differing from traditional robotics that emphasizes mechanical tasks in various industries.

Current applications of social robots are mainly in children's toys and devices designed to comfort the elderly and handicapped, highlighting their role in enhancing emotional well-being rather than performing physical tasks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of recent research in social robotics. Sheridan, TB.[2021]

Socially assistive robots show promise in supporting geriatric psychiatric care, especially during the COVID-19 pandemic, by providing safe and effective interventions for vulnerable populations.

Current research indicates that while these robots are still in early clinical stages, they demonstrate usability across various psychiatric conditions and are expected to improve in precision and efficacy for clinical outcomes in the near future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Approaches to assessing the impact of robotics in geriatric mental health care: a scoping review. Kulpa, E., Rahman, AT., Vahia, IV.[2021]

Telepresence robots show promise in enhancing social connection for people with dementia, based on a review of four studies that explored their feasibility and acceptability in real-time communication with carers.

Despite positive outcomes, challenges such as user experience and technological issues were noted, indicating a need for further systematic studies and clinical trials to better understand their efficacy in dementia care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential of telepresence robots to enhance social connectedness in older adults with dementia: an integrative review of feasibility. Moyle, W., Arnautovska, U., Ownsworth, T., et al.[2018]

The robotic assistant, RAMCIP, was evaluated by 18 elderly participants (10 healthy and 8 with mild cognitive impairments) and was found to have high perceived attractiveness and societal impact, indicating positive reception among users.

Despite the overall positive feedback, the usability of the device was rated as neutral, likely due to the limited duration of interaction during the study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of Perceived Attractiveness, Usability, and Societal Impact of a Multimodal Robotic Assistant for Aging Patients With Memory Impairments. Gerłowska, J., Skrobas, U., Grabowska-Aleksandrowicz, K., et al.[2020]

This study is the first randomized controlled trial investigating the use of PARO, a therapeutic pet robot, to improve mood and enhance social interaction in 40 older adults with mild to moderate dementia, conducted over six weekly sessions.

The outcomes will assess not only mood and social engagement but also cognitive function and caregiver burden, providing a comprehensive evaluation of PARO's effectiveness in dementia care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a Therapeutic, Socially Assistive Pet Robot (PARO) in Improving Mood and Stimulating Social Interaction and Communication for People With Dementia: Study Protocol for a Randomized Controlled Trial. Yu, R., Hui, E., Lee, J., et al.[2020]

Socially assistive robots (SARs) have been shown to significantly reduce symptoms of depression and anxiety in older adults with dementia, while also enhancing positive emotional experiences and social interactions through conversation, based on a meta-analysis of 14 randomized controlled trials.

Despite these benefits, SARs did not lead to significant improvements in agitation, overall behavioral and psychological symptoms of dementia (BPSD), or quality of life, indicating that their effects may be limited in certain areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Socially Assistive Robots for People Living with Dementia in Long-Term Facilities: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Hsieh, CJ., Li, PS., Wang, CH., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10407835/

Socially Assistive Robots for People Living with Dementia in ... SARs can help people living with dementia reduce their NPS of depression and anxiety, provide happiness from positive emotional experiences, and improve their ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0167494324000852

Socially Assistive Robots for patients with Alzheimer's ... We conducted a comprehensive scoping review emphasizing on the interaction of SAR with AD patients, with a specific focus on daily life support, cognitive ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05178992

Use of Socially Assistive Robots for Long Term Care Older ... The objective of this study is to demonstrate the impact of a socially assistive robot system on reducing apathy among cognitively impaired older adults.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10454070/

Effectiveness of Robot Interventions for Cognitive and ... The meta-analyses revealed that robot interventions significantly decreased anxiety and agitation but exerted no significant effects on cognitive function.

5. nature.com nature.com/articles/s41599-025-05498-0

Socially assistive robots and meaningful work: the case of ... This paper addresses these questions by examining the relationship between SARs and the meaningfulness of care work.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10977933/

Socially Assistive Robots for Dementia Care Socially assistive robots (SARs) have been investigated as a technology intervention to facilitate dementia caregiving (Chen et al., 2020; Chu et al., 2017, ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4512026/

“Are we ready for robots that care for us?” Attitudes and ... Socially Assistive Robots (SAR) may help improve care delivery at home for older adults with cognitive impairment and reduce the burden of informal caregivers.