Cognitive ChangeMCINCT04051918
Robot-assisted Cognitive Training for Lonely Older Adults With Mild Cognitive Impairment (MCI)
A study testing Piano Training in people with Cognitive Change and Cognitive Impairment, Mild, run by University of Georgia at 1 site in United States.
Trial summary
This study will use a socially assistive robot to deliver cognitive training in the form of a music (piano) learning intervention to socially isolated older adults with mild cognitive impairment. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cognitive Change, Cognitive Impairment, Mild, Aging
- What is being tested?
- Piano Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2021to 31 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- No previous diagnosis of Alzheimer's disease or related dementias
- No condition that limits movement of the hands or fingers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Robot-Assisted Cognitive Training for Socially Isolated Older Adults With Mild Cognitive Impairment
This study will use a socially assistive robot to deliver cognitive training in the form of a music (piano) learning intervention to socially isolated older adults with mild cognitive impairment.
Read the 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.
- Conditions
- Cognitive Change, Cognitive Impairment, Mild, Aging
- Being tested
- Piano Training
- Keywords
- cognitive training, socially assistive robotics, music learning
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Piano TrainingBehavioural
Cognitive training via music learning
| Study group | Role | What they receive |
|---|---|---|
| Socially Assistive Robot Intervention | Experimental | Piano training intervention led by a semi-autonomous socially assistive robot Receives: Behavioral: Piano Training |
| Content Only Intervention | Active comparator | Piano training intervention using the same curriculum displayed on a computer monitor, without the socially assistive robot tutor. Receives: Behavioral: Piano Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Verbal Memory Test
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
Measured: 6-months
Visual Memory Test
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
Measured: 6-months
Non-Verbal Reasoning Test
correct responses - commission errors; higher score is better
Measured: 6-months
Shifting Attention Test
correct responses - errors; higher is better
Measured: 6-months
Stroop Test
[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)
Measured: 6-months
Continuous Performance Test
CPT Correct Responses >= 30 AND CPT Correct Responses > CPT Commission Errors
Measured: 6-months
Symbol Digit Coding Test
SDC Correct Responses >= 20 AND Correct Responses > Errors
Measured: 6-months
Secondary outcomes (3)
Technology Acceptance - TAM3
higher sore = greater acceptance
Measured: 6-months
DeJong Loneliness Scale
Higher scores indicate more severe loneliness
Measured: 6-months
NASA TLX
Measures workload; higher score = more work
Measured: 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2019
- Study start7 Oct 2021
- Primary completion31 Aug 2023 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ChangeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Older adults with mild cognitive impairment
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Georgia
- Sponsor type
- University, hospital or other
- Collaborators
- Applied Universal Dynamics, Corp., Van Robotics, Inc.
- Responsible party
- Principal investigator, Jenay M. Beer, University of Georgia
- Investigators
- Jenay Beer, Ph.D., Principal investigator, The University of Georgia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04051918
- Sponsor's protocol ID
- PROJECT00000940
- Acronym
- MCI
- Status last verified
- Nov 2022
- First submitted
- 8 Aug 2019
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared with researchers outside of the study site.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robot-Assisted Cognitive Training for Socially Isolated Older Adults With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT04051918
- Acronym / sponsor ID
- MCI / PROJECT00000940
- Conditions
- Cognitive Change, Cognitive Impairment, Mild, Aging
- Keywords
- cognitive training, socially assistive robotics, music learning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of GeorgiaUniversity, hospital or other
- Collaborators
- Applied Universal Dynamics, Corp., Van Robotics, Inc.
- Study start
- 7 Oct 2021 (actual)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 9 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will use a socially assistive robot to deliver cognitive training in the form of a music (piano) learning intervention to socially isolated older adults with mild cognitive impairment.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Older adults with mild cognitive impairment
| Arm | Type | Receives |
|---|---|---|
| Socially Assistive Robot Intervention | Experimental | Behavioral: Piano TrainingPiano training intervention led by a semi-autonomous socially assistive robot |
| Content Only Intervention | Active comparator | Behavioral: Piano TrainingPiano training intervention using the same curriculum displayed on a computer monitor, without the socially assistive robot tutor. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (2 listed)
- No previous diagnosis of Alzheimer's disease or related dementias
- No condition that limits movement of the hands or fingers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Piano TrainingCognitive training via music learning | Behavioural | Content Only Intervention, Socially Assistive Robot Intervention |
Primary outcome
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
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
Non-Verbal Reasoning Test
Time frame: 6-months
correct responses - commission errors; higher score is better
Shifting Attention Test
Time frame: 6-months
correct responses - errors; higher is better
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)
Continuous Performance Test
Time frame: 6-months
CPT Correct Responses >= 30 AND CPT Correct Responses > CPT Commission Errors
Symbol Digit Coding Test
Time frame: 6-months
SDC Correct Responses >= 20 AND Correct Responses > Errors
3 secondary outcomes
Technology Acceptance - TAM3
Time frame: 6-months
DeJong Loneliness Scale
Time frame: 6-months
NASA TLX
Time frame: 6-months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Individual participant dataSharing planned: No. IPD will not be shared with researchers outside of the study site.
Related trials for Cognitive Change
Recruiting
Telehealth-Adapted Compensatory Training and Intervention for Cognition
MCI, Mild Cognitive Impairment
Recruiting
Neurobehavioral Changes Following Spaceflight Stressors
Stressor, Individual, Alcohol Impairment
RecruitingPhase 1
A Study of LY3439539 in Participants With Alzheimer's Disease
Alzheimer Disease
Not yet recruiting
Magnetoencephalographic Correlates of Clinical Change After Cognitive Processing Therapy in Adults With PTSD
Trauma, Psychological, Traumatic Stress Disorder
Not yet recruiting
Measuring Brain Changes Following Cognitive Intervention in Pediatric Patients With Brain Tumors
Brain Tumor, Pediatric
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jenay Beer, Ph.D. principal investigator
The University of Georgia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Piano Training in people with Cognitive Change and Cognitive Impairment, Mild, run by University of Georgia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Verbal Memory Test (time frame: 6-months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2022.