Socially Assistive Robots for Interaction With Older Adults With Dementia

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Alzheimer Disease

Intervention / Treatment
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* Behavioral: Play Serious Games with a Social Robot (Ryan)
* Behavioral: Play Solitary Games Without a Social Robot


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group<br>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<br>* Control Group: Group 2 will play solitary games (e.g., word puzzles) and activities but will have no interaction with Ryan.<br>|
| Experimental: Active Group<br>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)<br>* Active Group: Game play and physical activities with Ryan, a socially assistive robot developed at DreamFace Technologies,LLC.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in cognitive/memory ability | 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 over 1 year duration of the study (baseline, 6 months, and 1 year). | baseline, 6 months, and 1 year |