- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04051918
Robot-assisted Cognitive Training for Lonely Older Adults With Mild Cognitive Impairment (MCI) (MCI)
Robot-Assisted Cognitive Training for Socially Isolated Older Adults With Mild Cognitive Impairment
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Cognitive training has been shown in past research to improve cognitive function in older adults with and without mild cognitive impairment. Music learning has been previously shown to be a particularly effective form of cognitive training: in addition to the cognitive demands of learning notation, hand positioning, coordination and timing, those who engage in music learning also benefit from emotional connection to the music and social engagement with a music teacher.
Not all older adults are able to access music lessons. Older adults who are homebound, live in rural areas and do not have access to reliable transportation (or a monthly income with sufficient funds for recurring payments for lessons) are unlikely to be able to access these benefits. Socially assistive robots that can deliver both education and companionship on an ongoing basis within the home environment may be a viable solution to these limitations.
The purpose of this study is to deliver cognitive training in the form of a music (piano) learning intervention to older adults who are socially isolated, and who may be able to benefit from the cognitive training aspects of the intervention. A socially assistive robot will deliver the intervention.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Georgia
-
Athens, Georgia, United States, 30602
- University of Georgia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Be able to speak, read and write in English with a high degree of fluency
- Cumulative music learning experience < 3 years
- Able to sit upright for two hours at a time
- Able to see images on a screen at a distance of approximately 20 inches
- Must have independent transportation to and from the Institute of Gerontology, weekly, for 27 weeks
- No hearing impairment beyond what is correctable via hearing aid
- Must have a safe location in the home to store and use an 88-key keyboard + stand and piano bench
- No more than mildly cognitively impaired: global deterioration scale no higher than 2-3; Clinical Dementia Rating Scale no higher than 0.5 (sum of boxes)
- Must have a close companion, family member or loved one who can attend the first and last visit
- Must be capable of providing informed consent (based on responses to questions on study purpose, tasks, benefits, incentives and risks).
- Must have a computer or tablet that is connected to broadband internet, to be used three times over the course of the study
- Must have access to an e-mail account that can be checked three times during the study
Exclusion criteria:
- No previous diagnosis of Alzheimer's disease or related dementias
- No condition that limits movement of the hands or fingers
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Socially Assistive Robot Intervention
Piano training intervention led by a semi-autonomous socially assistive robot
|
Cognitive training via music learning
|
ACTIVE_COMPARATOR: Content Only Intervention
Piano training intervention using the same curriculum displayed on a computer monitor, without the socially assistive robot tutor.
|
Cognitive training via music learning
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Verbal Memory Test
Time Frame: 6-months
|
Correct hits + Correct passes + Correct hits after 30-minute delay + Correct passes after 30-minute delay; higher score is better; items remembered from a word list that also contains distractors
|
6-months
|
Visual Memory Test
Time Frame: 6-months
|
Correct hits + Correct passes + Correct hits after 30-minute delay + Correct passes after 30-minute delay; higher score is better; images remembered from an image list that also contains distractors
|
6-months
|
Non-Verbal Reasoning Test
Time Frame: 6-months
|
correct responses - commission errors; higher score is better
|
6-months
|
Shifting Attention Test
Time Frame: 6-months
|
correct responses - errors; higher is better
|
6-months
|
Stroop Test
Time Frame: 6-months
|
[Simple RT < (Complex RT Correct *0.1)+Complex RT Correct] AND [Complex RT Correct < ( Stroop RT Correct *0.1)+Stroop RT Correct] AND (Complex Correct > Complex Errors) AND (Stroop Correct > Stroop Errors)
|
6-months
|
Continuous Performance Test
Time Frame: 6-months
|
CPT Correct Responses >= 30 AND CPT Correct Responses > CPT Commission Errors
|
6-months
|
Symbol Digit Coding Test
Time Frame: 6-months
|
SDC Correct Responses >= 20 AND Correct Responses > Errors
|
6-months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Technology Acceptance - TAM3
Time Frame: 6-months
|
higher sore = greater acceptance
|
6-months
|
DeJong Loneliness Scale
Time Frame: 6-months
|
Higher scores indicate more severe loneliness
|
6-months
|
NASA TLX
Time Frame: 6-months
|
Measures workload; higher score = more work
|
6-months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Global deterioration scale
Time Frame: 6-months
|
Staging of cognitive impairment based on a structured clinical interview; higher score = more severe impairment
|
6-months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jenay Beer, Ph.D., The University of Georgia
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PROJECT00000940
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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