Socially Assistive Robots for Interaction With Older Adults With Dementia

NCT ID: NCT04384978

Last Updated: 2024-07-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-12

Study Completion Date

2022-04-15

Brief Summary

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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.

Detailed Description

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Conditions

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Alzheimer Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Control Group

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

Group Type ACTIVE_COMPARATOR

Play Solitary Games Without a Social Robot

Intervention Type BEHAVIORAL

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

Active Group

Active Group: Group 1 users will play games with and administered by Ryan, 2-3 times a week and 30-minutes per day.

Group Type EXPERIMENTAL

Play Serious Games with a Social Robot (Ryan)

Intervention Type BEHAVIORAL

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

Interventions

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Play Serious Games with a Social Robot (Ryan)

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

Intervention Type BEHAVIORAL

Play Solitary Games Without a Social Robot

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

DreamFace Technologies, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Mohammad Mahoor

Founder and CEO

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Eaton Senior Communities

Lakewood, Colorado, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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R44AG066439-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2020-001

Identifier Type: -

Identifier Source: org_study_id

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