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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 8
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I have lived in a long-term care facility for more than 3 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to week 8
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 8
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Apathy
Secondary outcome measures
Glycogen
Change in Trail Making Test (TMT)
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.
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Who is running the clinical trial?
Vanderbilt UniversityLead Sponsor
703 Previous Clinical Trials
6,143,147 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,671 Previous Clinical Trials
28,016,863 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.You have not corrected your vision or hearing with glasses, contacts, or hearing aids.I have never spoken English.I have lived in a long-term care facility for more than 3 months.I have significant memory or thinking problems.You have experienced memory or thinking problems, based on test scores.I cannot sit comfortably in a chair.You are very sick, near the end of life, or not able to respond.You have severe apathy symptoms, as indicated by a score of 30 or higher on a specific test.You tend to be very aggressive or argumentative.
Research Study Groups:
This trial has the following groups:- Group 1: Socially Assistive Robot Activity
- Group 2: Usual Activity Program
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the quota of participants for this clinical research?
"That is accurate. According to clinicaltrials.gov, this medical experiment was originally posted on September 13th 2021 and recently updated at the start of 2022. 200 individuals are required from one trial site for successful enrolment in the study."
Answered by AI
Is this research endeavor actively seeking participants?
"Affirmative. According to clinicaltrials.gov, this investigation is still seeking volunteers; the posting was made on September 13th 2021 and updated lastly on January 4th 2022. 200 patients need to be enrolled from a single centre for the study's completion."
Answered by AI
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