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| ID | Type | Description | Link |
|---|---|---|---|
| R44AG066439-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Active Comparator | Control Group: Group 2 users will play solitary games (word puzzles) and activities but will have no interaction with Ryan. |
|
| Active Group | Experimental | Active Group: Group 1 users will play games with and administered by Ryan, 2-3 times a week and 30-minutes per day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Play Serious Games with a Social Robot (Ryan) | Behavioral | Active Group: Game play and physical activities with Ryan, a socially assistive robot developed at DreamFace Technologies,LLC. |
| 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. | assessed at baseline (week 1), week 4, and 8. Week 8 reported. |
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Inclusion Criteria
Exclusion Criteria:
Aggressive behavior
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eaton Senior Communities | Lakewood | Colorado | 80226 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 participants did not complete the study. | Posted | Mean | Standard Deviation | score on a scale | assessed at baseline (week 1), week 4, and 8. Week 8 reported. |
|
The adverse events were monitored and assessed at the participant level (up to 10 weeks) throughout the study. As a result, no adverse events were reported during the study period.
No adverse event was reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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The study was conducted right after COVID-19 restrictions were lifted. The main limitation was that some potential subjects had medical constraints or concerns and did not want to participate. Additionally, poor internet connections in some senior care facilities limited the ability to converse with the robot.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| President and CEO | DreamFace Technologies, LLC | 7202015694 | mmahoor@dreamfacetech.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 20, 2021 | May 23, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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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.
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| Play Solitary Games Without a Social Robot | Behavioral | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Year |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| The Saint Louis University Mental Status (SLUMS) | The SLUMS exam tests several cognitive domains, as listed below: Verbal memory (13 points) Attention/concentration (5 points) Visuospatial/constructional abilities (5 points). The scale range is between 0-30 and the higher the score the better. For individuals who have completed a high school education, the SLUMS score structure is as follows: 27-30: Indicates regular cognitive function. 21-26: Indicates mild cognitive impairment. 1-20: Indicates dementia. | Mean | Standard Deviation | units on a scale |
|
| OG001 | 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. |
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | 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. | 0 | 18 | 0 | 18 | 0 | 18 |
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |