Socially Assistive Robots to Enhance Magnification Device Use for Reading

NCT04190134 | Recruiting Phase 1

• 1 other identifier: 19-001429
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The aims of this exploratory research project are to customize, deploy and evaluate the preliminary efficacy of a socially assistive robot as a novel approach to motivate and encourage optimal, long-term use of new magnification devices for reading in individuals with vision loss. The goals are to promote patient acceptance, adherence and skills reinforcement to achieve proficiency in the use of the magnifier, in order to attempt to reduce visual disability while performing important daily activities, such as reading tasks. This is a high priority given the increasing prevalence of low vision, paucity of low vision rehabilitation providers, and barriers related to access to care, such as transportation and geography, all of which motivate the development of this complementary approach for the provision of additional support at home by the socially assistive robot.

Conditions

Low Vision

Keywords

robot

Outcome Measures

Primary Outcomes (1)

• Activity Inventory

  questionnaire; scores will be Rasch analyzed in logic units with higher or positive scores indicating less difficulty (i.e., improvement)

  change from 1 month post-enrollment to 2-3 months after receiving the socially assistive robot

Secondary Outcomes (8)

• MNread

  For Immediate robot: baseline, 1 month, 3 months, 6 months. For Delayed/Waitlist robot: baseline, 3 months, 6 months.

• Sustained Silent Reading Test

  baseline and monthly for 6 months

• Geriatric Depression Scale (GDS)

  baseline and monthly for 6 months

• PANAS

  baseline and monthly for 6 months

• Perceived Stress Scale

  baseline and monthly for 6 months

Study Arms (2)

Immediate Robot

EXPERIMENTAL

One month after study entry, participants will receive the robot at home for two months, followed by a three month observation period without the robot.

Behavioral: Socially Assistive Robot for Low Vision Rehabilitation

Delayed/Waitlist Robot

ACTIVE COMPARATOR

Three months after study entry, participants will receive the robot at home for three months.

Behavioral: Socially Assistive Robot for Low Vision Rehabilitation

Interventions

Socially Assistive Robot for Low Vision Rehabilitation BEHAVIORAL

A socially assistive robot will be customized to engage in dialog and conversations to motivate and encourage optimal use of new magnification devices for reading at home by individuals with vision loss.

Delayed/Waitlist Robot; Immediate Robot

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals with any level of vision loss due to any ocular disease,
• age 18 and older,
• received a magnification device(s) (i.e., hand-held optical magnifiers, portable electronic video magnifiers, some stand magnifiers and CCTVs) from the UCLA Vision Rehabilitation Center.

You may not qualify if:

• schedules not permitting participation in planned study sessions or visits (including planning to move or take extended vacation during study period),
• inability to understand study procedures or communicate responses to visual stimuli in a consistent manner (cognitive impairment as per TICS),
• substance abuse,
• significant hearing loss (unable to hear communication by phone or from robot),
• significant medical condition likely to limit participation or lifespan,
• their magnifier device has features that would not work in conjunction with the beacon sensors: (1) hands-free and do not have a place where the patient's hand is holding the device during use (therefore, they would not register a significant change in temperature), and/or (2) no surface area of at least 1"x1" to which the beacon sensor could be attached without interfering with the device.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• University of Southern California: collaborator

Study Sites (1)

UCLA Stein Eye Institute

Los Angeles, California, 90095, United States

RECRUITING

MeSH Terms

Conditions

Vision, Low

Interventions

Robotics

Condition Hierarchy (Ancestors)

Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Automation; Technology; Technology, Industry, and Agriculture

Study Officials

• Ava K Bittner, OD, PhD

  UCLA Stein Eye Institute; Vision Rehabilitation Center

  PRINCIPAL INVESTIGATOR

• Maja J Mataric, PhD

  USC Interaction Lab; Viterbi School of Engineering

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ava K Bittner, OD, PhD

CONTACT

310-206-4649; abittner@mednet.ucla.edu

Andrea Obligacion

CONTACT

310-206-9566; AObligacion@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 3, 2019
• First Posted: December 9, 2019
• Study Start: April 22, 2022
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: July 19, 2024

Record last verified: 2024-07

Locations

US (1)