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OpenTrials
Completed

NCT Number: NCT04384978

Socially Assistive Robots for Interaction With Older Adults With Dementia

A 12-month pilot study will be comprised of two groups of people diagnosed with mild Alzheimer's disease and related dementia for a total of 80 senior subjects. Subjects will be randomly assigned to two groups: Group 1 users will play games with and administered by Ryan, 2-3 times a week and 30-minutes per day. Group 2 (Active Control Group) will play solitary games and activities but will have to interaction with Ryan. The team will measure the changes and improvement in the social/emotional well-being of these two groups and eventual changes in the cognitive/memory functions of elderly people living in the similar environment.

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eaton Senior Communities

Lakewood, Colorado, 80226, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 65 years
  • Early Alzheimer's disease and related dementia diagnosed by a qualified provider
  • Saint Louis University Mental Status (SLUMS) score between 10 and 25
  • Resident of assisted living facility for at least one month prior and for the duration of the study
  • Deemed conditioned enough to participate in physical activities after a wellness check
  • Verbal skill to interact
  • Participant or Legal decision

Exclusion criteria

Aggressive behavior

  • Diagnosed with severe dementia or memory loss
  • Acute physical illness that impairs ability to participate
  • Patients with serious comorbidity, tumors and other diseases casually related to cognitive impairment
  • History of alcohol or drug abuse, head trauma, psychoactive substance use and other causes of memory impairment
  • Significant sensory impairment

Treatment and study plan

Play Serious Games with a Social Robot (Ryan)

Behavioral

Active Group: Game play and physical activities with Ryan, a socially assistive robot developed at DreamFace Technologies,LLC.

Play Solitary Games Without a Social Robot

Behavioral

Control Group: Group 2 will play solitary games (e.g., word puzzles) and activities but will have no interaction with Ryan.

Primary outcomes

  1. Change in Cognitive/Memory Ability

    Time frame: assessed at baseline (week 1), week 4, and 8. Week 8 reported.

    Participants will complete the Saint Louis University Mental Status (SLUMS) test, a screening method for Alzheimer's and other dementia. Scores range from 0 to 30. Scores of 27 to 30 are considered normal in a person with a high school education. Scores between 21 and 26 suggest a mild neurocognitive disorder. Scores between 0 and 20 indicate dementia.

Sponsors and collaborators

Lead sponsor

DreamFace Technologies, LLC

Industry

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Development of Serious Games and Physical Activities Instructed by a Social Robot for Improving the Well-being of Elderly Individuals With Alzheimer's Disease and Dementia

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
May 12, 2020
Registry last updated
Jul 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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