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

Trial Summary

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 data supports the effectiveness of the treatment Socially Assistive Robot Activity for cognitive impairment?

Research shows that socially assistive robots can improve social connection and interaction for people with dementia, which may enhance their quality of life. These robots have been found to positively impact mood and social engagement, suggesting potential benefits for cognitive impairment. ^{1 2 3 4 5}

Is it safe for humans to interact with socially assistive robots for cognitive impairment?

Research on socially assistive robots for older adults, including those with cognitive impairments, suggests that these robots are generally safe for human interaction. Studies have focused on their potential benefits for social engagement and care support, with no significant safety concerns reported. ^{1 3 5 6 7}

How does the social robot interaction treatment differ from other treatments for cognitive impairment?

Social robot interaction is unique because it uses robots to enhance social connections and engagement, which can improve the quality of life for people with cognitive impairment. Unlike traditional treatments that may focus on medication or cognitive exercises, this approach leverages technology to facilitate real-time communication and social interaction, providing a novel way to support mental and emotional well-being. ^{1 2 5 8 9}

What is the purpose of this trial?

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Canada 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. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Potential of telepresence robots to enhance social connectedness in older adults with dementia: an integrative review of feasibility. [2018]

3. Switzerland 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. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Approaches to assessing the impact of robotics in geriatric mental health care: a scoping review. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

SAR-Connect: A Socially Assistive Robotic System to Support Activity and Social Engagement of Older Adults. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

"Are we ready for robots that care for us?" Attitudes and opinions of older adults toward socially assistive robots. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Assessment of Perceived Attractiveness, Usability, and Societal Impact of a Multimodal Robotic Assistant for Aging Patients With Memory Impairments. [2020]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Caregiver and social assistant robot for rehabilitation and coaching for the elderly. [2016]

9. Netherlands pubmed.ncbi.nlm.nih.gov

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