Clinical trial NCT04384978: Socially Assistive Robots for Interaction With Older Adults With Dementia
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Lead sponsor: DreamFace Technologies, LLC
Sponsor class: INDUSTRY
Collaborators: name: National Institute on Aging (NIA)
First posted: 2020-05-12
Enrollment: 22
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Cognitive/Memory Ability
timeFrame: assessed at baseline (week 1), week 4, and 8. Week 8 reported.
Secondary outcomes:
Other outcomes:
Locations:
city: Lakewood
country: United States
facility: Eaton Senior Communities
state: Colorado
Study officials:
References: