Socially Assistive Robots for Interaction With Older Adults With Dementia

June 28, 2024 updated by: Mohammad Mahoor, DreamFace Technologies, LLC

Development of Serious Games and Physical Activities Instructed by a Social Robot for Improving the Well-being of Elderly Individuals With Alzheimer's Disease and Dementia

A 12-month pilot study will be comprised of two groups of people diagnosed with mild Alzheimer's disease and related dementia for a total of 80 senior subjects. Subjects will be randomly assigned to two groups: Group 1 users will play games with and administered by Ryan, 2-3 times a week and 30-minutes per day. Group 2 (Active Control Group) will play solitary games and activities but will have to interaction with Ryan. The team will measure the changes and improvement in the social/emotional well-being of these two groups and eventual changes in the cognitive/memory functions of elderly people living in the similar environment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Lakewood, Colorado, United States, 80226
        • Eaton Senior Communities

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • Age ≥ 65 years
  • Early Alzheimer's disease and related dementia diagnosed by a qualified provider
  • Saint Louis University Mental Status (SLUMS) score between 10 and 25
  • Resident of assisted living facility for at least one month prior and for the duration of the study
  • Deemed conditioned enough to participate in physical activities after a wellness check
  • Verbal skill to interact
  • Participant or Legal decision

Exclusion Criteria:

Aggressive behavior

  • Diagnosed with severe dementia or memory loss
  • Acute physical illness that impairs ability to participate
  • Patients with serious comorbidity, tumors and other diseases casually related to cognitive impairment
  • History of alcohol or drug abuse, head trauma, psychoactive substance use and other causes of memory impairment
  • Significant sensory impairment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Group
Control Group: Group 2 users will play solitary games (word puzzles) and activities but will have no interaction with Ryan.
Behavioral: Play Solitary Games Without a Social Robot
Control Group: Group 2 will play solitary games (e.g., word puzzles) and activities but will have no interaction with Ryan.
Experimental: Active Group
Active Group: Group 1 users will play games with and administered by Ryan, 2-3 times a week and 30-minutes per day.
Behavioral: Play Serious Games with a Social Robot (Ryan)
Active Group: Game play and physical activities with Ryan, a socially assistive robot developed at DreamFace Technologies,LLC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Cognitive/Memory Ability
Time Frame: assessed at baseline (week 1), week 4, and 8. Week 8 reported.
Participants will complete the Saint Louis University Mental Status (SLUMS) test, a screening method for Alzheimer's and other dementia. Scores range from 0 to 30. Scores of 27 to 30 are considered normal in a person with a high school education. Scores between 21 and 26 suggest a mild neurocognitive disorder. Scores between 0 and 20 indicate dementia.
assessed at baseline (week 1), week 4, and 8. Week 8 reported.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DreamFace Technologies, LLC

Collaborators

National Institute on Aging (NIA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2020

Primary Completion (Actual)

March 6, 2022

Study Completion (Actual)

April 15, 2022

Study Registration Dates

First Submitted

May 5, 2020

First Submitted That Met QC Criteria

May 11, 2020

First Posted (Actual)

May 12, 2020

Study Record Updates

Last Update Posted (Actual)

July 23, 2024

Last Update Submitted That Met QC Criteria

June 28, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-001
  • R44AG066439-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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