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

Sponsor
University of Georgia (Other)
Overall Status
Recruiting
CT.gov ID
NCT04051918
Collaborator
Applied Universal Dynamics, Corp. (Other), Van Robotics, Inc. (Other)
40
1
2
22.8
1.8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Piano Training
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
Older adults with mild cognitive impairmentOlder adults with mild cognitive impairment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Robot-Assisted Cognitive Training for Socially Isolated Older Adults With Mild Cognitive Impairment
Actual Study Start Date :
Oct 7, 2021
Anticipated Primary Completion Date :
Aug 31, 2023
Anticipated Study Completion Date :
Aug 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Socially Assistive Robot Intervention

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

Behavioral: Piano Training
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.

Behavioral: Piano Training
Cognitive training via music learning

Outcome Measures

Primary Outcome Measures

  1. Verbal Memory Test [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

  2. Visual Memory Test [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

  3. Non-Verbal Reasoning Test [6-months]

    correct responses - commission errors; higher score is better

  4. Shifting Attention Test [6-months]

    correct responses - errors; higher is better

  5. Stroop Test [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. Continuous Performance Test [6-months]

    CPT Correct Responses >= 30 AND CPT Correct Responses > CPT Commission Errors

  7. Symbol Digit Coding Test [6-months]

    SDC Correct Responses >= 20 AND Correct Responses > Errors

Secondary Outcome Measures

  1. Technology Acceptance - TAM3 [6-months]

    higher sore = greater acceptance

  2. DeJong Loneliness Scale [6-months]

    Higher scores indicate more severe loneliness

  3. NASA TLX [6-months]

    Measures workload; higher score = more work

Other Outcome Measures

  1. Global deterioration scale [6-months]

    Staging of cognitive impairment based on a structured clinical interview; higher score = more severe impairment

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Georgia Athens Georgia United States 30602

Sponsors and Collaborators

  • University of Georgia
  • Applied Universal Dynamics, Corp.
  • Van Robotics, Inc.

Investigators

  • Principal Investigator: Jenay Beer, Ph.D., The University of Georgia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jenay M. Beer, Assistant Professor, University of Georgia
ClinicalTrials.gov Identifier:
NCT04051918
Other Study ID Numbers:
  • PROJECT00000940
First Posted:
Aug 9, 2019
Last Update Posted:
Nov 9, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jenay M. Beer, Assistant Professor, University of Georgia
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 9, 2021