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

NCT04051918 | Unknown DMC

• 1 other identifier: PROJECT00000940
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Change; Cognitive Impairment, Mild; Aging

Keywords

cognitive training; socially assistive robotics; music learning

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• Non-Verbal Reasoning Test

  correct responses - commission errors; higher score is better

  6-months

• Shifting Attention Test

  correct responses - errors; higher is better

  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)

  6-months

• Continuous Performance Test

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

  6-months

• Symbol Digit Coding Test

  SDC Correct Responses \>= 20 AND Correct Responses \> Errors

  6-months

Secondary Outcomes (3)

• Technology Acceptance - TAM3

  6-months

• DeJong Loneliness Scale

  6-months

• NASA TLX

  6-months

Other Outcomes (1)

• Global deterioration scale

  6-months

Study Arms (2)

Socially Assistive Robot Intervention

EXPERIMENTAL

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

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.

Behavioral: Piano Training

Interventions

Piano Training BEHAVIORAL

Cognitive training via music learning

Content Only Intervention; Socially Assistive Robot Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• No previous diagnosis of Alzheimer's disease or related dementias
• No condition that limits movement of the hands or fingers

Sponsors & Collaborators

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

Study Sites (1)

University of Georgia

Athens, Georgia, 30602, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Jenay Beer, Ph.D.

  The University of Georgia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Older adults with mild cognitive impairment

Study Record Dates

• First Submitted: August 8, 2019
• First Posted: August 9, 2019
• Study Start: October 7, 2021
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: November 2, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)