Socially Assistive Robots for Interaction With Older Adults With Dementia

Alzheimer Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04384978
• Other study ID #: 2020-001
• Secondary ID: R44AG066439-01
• Status: Completed
• Phase: N/A
• Start date: January 12, 2020
• Est. completion date: April 15, 2022

Study information

• Verified date: February 2024
• Source: DreamFace Technologies, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: April 15, 2022
• Est. primary completion date: March 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Eaton Senior Communities	Lakewood	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
DreamFace Technologies, LLC	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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