Trial Outcomes & Findings for Socially Assistive Robots for Interaction With Older Adults With Dementia (NCT NCT04384978)
NCT ID: NCT04384978
Last Updated: 2024-07-23
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
22 participants
Primary outcome timeframe
assessed at baseline (week 1), week 4, and 8. Week 8 reported.
Results posted on
2024-07-23
Participant Flow
Participant milestones
| Measure |
Control Group
Control Group: Group 2 users will play solitary games (word puzzles) and activities but will have no interaction with Ryan.
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.
|
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.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
18
|
|
Overall Study
COMPLETED
|
0
|
18
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
Reasons for withdrawal
| Measure |
Control Group
Control Group: Group 2 users will play solitary games (word puzzles) and activities but will have no interaction with Ryan.
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.
|
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.
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
0
|
Baseline Characteristics
Socially Assistive Robots for Interaction With Older Adults With Dementia
Baseline characteristics by cohort
| Measure |
Control Group
n=4 Participants
Control Group: Group 2 users will play solitary games (word puzzles) and activities but will have no interaction with Ryan.
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.
|
Active Group
n=18 Participants
Active Group: Group 1 users will play games with and administered by Ryan, 2-3 times a week and 30-minutes per day.
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.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Age, Continuous
|
80.20 Year
STANDARD_DEVIATION 5.44 • n=99 Participants
|
76.2 Year
STANDARD_DEVIATION 6.11 • n=107 Participants
|
77.7 Year
STANDARD_DEVIATION 6.43 • n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Caucasian
|
4 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
The Saint Louis University Mental Status (SLUMS)
|
19.12 units on a scale
STANDARD_DEVIATION 4.10 • n=99 Participants
|
21.12 units on a scale
STANDARD_DEVIATION 3.20 • n=107 Participants
|
20.45 units on a scale
STANDARD_DEVIATION 3.34 • n=206 Participants
|
PRIMARY outcome
Timeframe: assessed at baseline (week 1), week 4, and 8. Week 8 reported.Population: The participants did not complete the study.
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.
Outcome measures
| Measure |
Active Group
n=18 Participants
Active Group: Group 1 users will play games with and administered by Ryan, 2-3 times a week and 30-minutes per day.
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.
|
Control Group
Control Group: Group 2 users will play solitary games (word puzzles) and activities but will have no interaction with Ryan.
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.
|
|---|---|---|
|
Change in Cognitive/Memory Ability
|
23.75 score on a scale
Standard Deviation 3.45
|
—
|
Adverse Events
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Active Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place