ClinicalTrials.gg
RecruitingNCT04190134Updated Jul 19, 2024

Socially Assistive Robots to Enhance Magnification Device Use for Reading

A Phase 1 interventional study of Socially Assistive Robot for Low Vision Rehabilitation in Low Vision, sponsored by University of California, Los Angeles. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-19.

Sponsored by University of California, Los Angeles · Phase 1, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Feb 2025, 1 year 9 months ago, but the record still lists the study as recruiting.
  • Started Apr 2022; still recruiting 4 years 6 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Low Vision

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Keywords

  • robot
03

In context

Vision, Low

98 studies on the registry are indexed under Vision, Low; 23 are open to participants now.

This study's planned enrollment of 20 is below the median of 60 across 78 interventional studies indexed under Vision, Low.

Browse Vision, Low studies →

Lead sponsor

University of California, Los Angeles is the lead sponsor of 1,170 studies on the registry; 195 are open to participants now.

Of its 95 completed or terminated interventional studies of FDA-regulated products, 70 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 1
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Immediate Robot

    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

  • Active comparator
    Delayed/Waitlist Robot

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

    Behavioral: Socially Assistive Robot for Low Vision Rehabilitation

Interventions

  • BehavioralSocially Assistive Robot for Low Vision Rehabilitation

    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.

06

What researchers measure

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)

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

Secondary outcomes

  1. MNread

    reading test

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

  2. Sustained Silent Reading Test

    reading test

    Time frame: baseline and monthly for 6 months

  3. Geriatric Depression Scale (GDS)

    questionnaire; scale ranges from 0 to 15 with higher values indicating greater depression

    Time frame: baseline and monthly for 6 months

  4. PANAS

    questionnaire; scale ranges from 10 to 50 with higher values indicating greater positive moods

    Time frame: baseline and monthly for 6 months

  5. Perceived Stress Scale

    questionnaire; scale ranges from 0 to 56 with higher values indicating greater perceived stress

    Time frame: baseline and monthly for 6 months

  6. 3-item UCLA Loneliness Scale

    questionnaire; scale ranges from 3 to 9 with higher values indicating greater loneliness

    Time frame: baseline and monthly for 6 months

  7. Duke Social Support Index

    questionnaire; scale ranges from 10 to 30 with higher values indicating greater social support

    Time frame: baseline and monthly for 6 months

  8. Almere

    questionnaire; scale ranges from 41 to 205 with higher values indicating greater acceptance of robots

    Time frame: 1 month post-enrollment and 2-3 months after receiving the socially assistive robot

07

Study locations

1 of 1 sites recruiting
  • UCLA Stein Eye Institute
    Los Angeles, California 90095, United States
    Recruiting
    • Ava K Bittner, OD, PhD · Contact310-206-4649
    • Ava K Bittner, OD, PhD · Principal investigator
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Apr 2022 (actual). Primary completion is estimated for Feb 2025, 34 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 3, 2019
First posted
Dec 9, 2019
StartActual
Apr 22, 2022
Primary completionEst.
Feb 2025
CompletionEst.
Feb 2025
Last update
Jul 19, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04190134
Responsible party
Ava K. Bittner, OD, PhD (Principal Investigator, University of California, Los Angeles) — Principal investigator
First posted
Dec 9, 2019
Start date
Apr 22, 2022
Primary completion
Feb 2025 (estimated)
Completion
Feb 2025 (estimated)
Last update
Jul 19, 2024

Study contacts

Ava K Bittner, OD, PhD
Contact
abittner@mednet.ucla.edu
310-206-4649
Andrea Obligacion
Contact
AObligacion@mednet.ucla.edu
310-206-9566
Ava K Bittner, OD, PhD
principal investigator · UCLA Stein Eye Institute; Vision Rehabilitation Center
Maja J Mataric, PhD
principal investigator · USC Interaction Lab; Viterbi School of Engineering

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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