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
Phase: NA
Conditions: Alzheimer Disease
Sponsor: DreamFace Technologies, LLC

Socially Assistive Robots for Interaction With Older Adults With Dementia 
NCT04384978 
Date: 4/20/2021 
 
Objectives. 
The study will evaluate the overall effectiveness of Ryan Companionbot (aka Ryan) with interactive gameplay to 
have a positive impact on a user’s cognitive function, performance of activities of daily living, and mood. An 
active control group will perform solitary physical and cognitive activities such as walking and crossword puzzles, 
sudoku, or solitaire. Our hypothesis is individuals playing interactive cognitive and physical games with Ryan will 
have a greater positive effect on cognitive function, performance of activities of daily living, and mood compared 
to individuals engaging in solitary physical and cognitive activities.  
 
Desing. 
The study addresses design and analysis problems common to published brain training intervention studies and 
follows recommended best practices of preregistration, adequate documentation, pretest baseline, control 
conditions, sampling and randomization, dosing, blinding, contingent analysis, statistical analysis, and 
scattershot publishing without full documentation The pilot study will be comprised of two groups of people 
diagnosed with mild Alzheimer's disease and related dementia senior subjects. Subjects will play games with 
and administered by Ryan, 2-3 times a week and 30-minutes per day. 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 a similar environment. 
 
Methods. 
The study with Ryan CompanionBot will occur in ESC’s and Kavod’s library or atrium or a location free of 
distractions and intrusion. A staff member will be present during all sessions to assist with user operation, 
document behavioral observations, and ensure the safety of participants by intervening if the subject shows 
signs of distress. Ryan’s sensors will record all of the subject’s activities and interactions including the gameplay. 
The system will record all dialogs between the subjects and Ryan, along with Ryan’s decisions for additional 
analysis of the individuals’ behaviors. Prior to running the sessions, we will interview each participant and his/her 
caregivers to understand the main weaknesses and problems related to physical and cognitive limitations from 
their dementia, and to learn about their favorite colors, objects, animals, music, names of close relatives, and 
cherished belongings to personalize the experience. 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. The measurement will be conducted 
three times throughout the study. 
 
Statistical Analysis Plan. 
Statistical analysis will include multi-way Analysis of Variance (ANOVA) to find the significance of the findings 
and the effect of different parameters and variables on the measured outcomes within and between the two 
groups.