search
Back to results

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

Primary Purpose

Cognitive Change, Cognitive Impairment, Mild, Aging

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Piano Training
Sponsored by
University of Georgia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cognitive Change focused on measuring cognitive training, socially assistive robotics, music learning

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Georgia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Socially Assistive Robot Intervention

Content Only Intervention

Arm Description

Piano training intervention led by a semi-autonomous socially assistive robot

Piano training intervention using the same curriculum displayed on a computer monitor, without the socially assistive robot tutor.

Outcomes

Primary Outcome Measures

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
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
Non-Verbal Reasoning Test
correct responses - commission errors; higher score is better
Shifting Attention Test
correct responses - errors; higher is better
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)
Continuous Performance Test
CPT Correct Responses >= 30 AND CPT Correct Responses > CPT Commission Errors
Symbol Digit Coding Test
SDC Correct Responses >= 20 AND Correct Responses > Errors

Secondary Outcome Measures

Technology Acceptance - TAM3
higher sore = greater acceptance
DeJong Loneliness Scale
Higher scores indicate more severe loneliness
NASA TLX
Measures workload; higher score = more work

Full Information

First Posted
August 8, 2019
Last Updated
November 1, 2022
Sponsor
University of Georgia
Collaborators
Applied Universal Dynamics, Corp., Van Robotics, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT04051918
Brief Title
Robot-assisted Cognitive Training for Lonely Older Adults With Mild Cognitive Impairment (MCI)
Acronym
MCI
Official Title
Robot-Assisted Cognitive Training for Socially Isolated Older Adults With Mild Cognitive Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 7, 2021 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Georgia
Collaborators
Applied Universal Dynamics, Corp., Van Robotics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Change, Cognitive Impairment, Mild, Aging
Keywords
cognitive training, socially assistive robotics, music learning

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Older adults with mild cognitive impairment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Socially Assistive Robot Intervention
Arm Type
Experimental
Arm Description
Piano training intervention led by a semi-autonomous socially assistive robot
Arm Title
Content Only Intervention
Arm Type
Active Comparator
Arm Description
Piano training intervention using the same curriculum displayed on a computer monitor, without the socially assistive robot tutor.
Intervention Type
Behavioral
Intervention Name(s)
Piano Training
Intervention Description
Cognitive training via music learning
Primary Outcome Measure Information:
Title
Verbal Memory Test
Description
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
Time Frame
6-months
Title
Visual Memory Test
Description
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
Time Frame
6-months
Title
Non-Verbal Reasoning Test
Description
correct responses - commission errors; higher score is better
Time Frame
6-months
Title
Shifting Attention Test
Description
correct responses - errors; higher is better
Time Frame
6-months
Title
Stroop Test
Description
[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)
Time Frame
6-months
Title
Continuous Performance Test
Description
CPT Correct Responses >= 30 AND CPT Correct Responses > CPT Commission Errors
Time Frame
6-months
Title
Symbol Digit Coding Test
Description
SDC Correct Responses >= 20 AND Correct Responses > Errors
Time Frame
6-months
Secondary Outcome Measure Information:
Title
Technology Acceptance - TAM3
Description
higher sore = greater acceptance
Time Frame
6-months
Title
DeJong Loneliness Scale
Description
Higher scores indicate more severe loneliness
Time Frame
6-months
Title
NASA TLX
Description
Measures workload; higher score = more work
Time Frame
6-months
Other Pre-specified Outcome Measures:
Title
Global deterioration scale
Description
Staging of cognitive impairment based on a structured clinical interview; higher score = more severe impairment
Time Frame
6-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jenay Beer, Ph.D.
Organizational Affiliation
The University of Georgia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Georgia
City
Athens
State/Province
Georgia
ZIP/Postal Code
30602
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD will not be shared with researchers outside of the study site.

Learn more about this trial

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

We'll reach out to this number within 24 hrs