Robot-assisted Cognitive Training for Lonely Older Adults With Mild Cognitive Impairment (MCI)

Aging Clinical Trial

— MCI  

Official title:

Robot-Assisted Cognitive Training for Socially Isolated Older Adults With Mild Cognitive Impairment

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04051918
• Other study ID #: PROJECT00000940
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 7, 2021
• Est. completion date: August 31, 2023

Study information

• Verified date: November 2022
• Source: University of Georgia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Cognitive Change
• Cognitive Dysfunction
• Cognitive Impairment, Mild

Intervention

Behavioral:
• Piano Training
Cognitive training via music learning

Locations

Country	Name	City	State
United States	University of Georgia	Athens	Georgia

Sponsors (3)

Lead Sponsor	Collaborator
University of Georgia	Applied Universal Dynamics, Corp., Van Robotics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Global deterioration scale	Staging of cognitive impairment based on a structured clinical interview; higher score = more severe impairment	6-months
Primary	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	6-months
Primary	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	6-months
Primary	Non-Verbal Reasoning Test	correct responses - commission errors; higher score is better	6-months
Primary	Shifting Attention Test	correct responses - errors; higher is better	6-months
Primary	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)	6-months
Primary	Continuous Performance Test	CPT Correct Responses >= 30 AND CPT Correct Responses > CPT Commission Errors	6-months
Primary	Symbol Digit Coding Test	SDC Correct Responses >= 20 AND Correct Responses > Errors	6-months
Secondary	Technology Acceptance - TAM3	higher sore = greater acceptance	6-months
Secondary	DeJong Loneliness Scale	Higher scores indicate more severe loneliness	6-months
Secondary	NASA TLX	Measures workload; higher score = more work	6-months