Low VisionPhase 1NCT04190134
Socially Assistive Robots to Enhance Magnification Device Use for Reading
A Phase 1 study testing Socially Assistive Robot for Low Vision Rehabilitation in people with Low Vision, run by University of California, Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Vision
- What is being tested?
- Socially Assistive Robot for Low Vision Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Apr 2022to Feb 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
UCLA Stein Eye Institute
Los Angeles, California, 90095
Ava K Bittner, OD, PhD, 310-206-4649
Ava K Bittner, OD, PhD
About this study
Official title: Development of a Behavioral Intervention With Socially Assistive Robots to Enhance Magnification Device Use for Reading
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
- Being tested
- Socially Assistive Robot for Low Vision Rehabilitation
- Keywords
- robot
- Medical subject headings
- Vision, Low
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Socially Assistive Robot for Low Vision RehabilitationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Socially Assistive Robot for Low Vision Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activity Inventory
questionnaire; scores will be Rasch analyzed in logic units with higher or positive scores indicating less difficulty (i.e., improvement)
Measured: change from 1 month post-enrollment to 2-3 months after receiving the socially assistive robot
Secondary outcomes (8)
MNread
reading test
Measured: For Immediate robot: baseline, 1 month, 3 months, 6 months. For Delayed/Waitlist robot: baseline, 3 months, 6 months.
Sustained Silent Reading Test
reading test
Measured: baseline and monthly for 6 months
Geriatric Depression Scale (GDS)
questionnaire; scale ranges from 0 to 15 with higher values indicating greater depression
Measured: baseline and monthly for 6 months
PANAS
questionnaire; scale ranges from 10 to 50 with higher values indicating greater positive moods
Measured: baseline and monthly for 6 months
Perceived Stress Scale
questionnaire; scale ranges from 0 to 56 with higher values indicating greater perceived stress
Measured: baseline and monthly for 6 months
3-item UCLA Loneliness Scale
questionnaire; scale ranges from 3 to 9 with higher values indicating greater loneliness
Measured: baseline and monthly for 6 months
Duke Social Support Index
questionnaire; scale ranges from 10 to 30 with higher values indicating greater social support
Measured: baseline and monthly for 6 months
Almere
questionnaire; scale ranges from 41 to 205 with higher values indicating greater acceptance of robots
Measured: 1 month post-enrollment and 2-3 months after receiving the socially assistive robot
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2019
- Study start22 Apr 2022
- Primary completionFeb 2025 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low VisionStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern California
- Responsible party
- Principal investigator, Ava K. Bittner, OD, PhD, University of California, Los Angeles
- Investigators
- Ava K Bittner, OD, PhD, Principal investigator, UCLA Stein Eye Institute; Vision Rehabilitation CenterMaja J Mataric, PhD, Principal investigator, USC Interaction Lab; Viterbi School of Engineering
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04190134
- Sponsor's protocol ID
- 19-001429
- Status last verified
- Jul 2024
- First submitted
- 3 Dec 2019
- Last updated
- 19 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Behavioral Intervention With Socially Assistive Robots to Enhance Magnification Device Use for Reading
- ClinicalTrials.gov ID
- NCT04190134
- Acronym / sponsor ID
- 19-001429
- Conditions
- Low Vision
- Keywords
- robot
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- University of Southern California
- Study start
- 22 Apr 2022 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 9 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Robot | Experimental | Behavioral: Socially Assistive Robot for Low Vision RehabilitationOne month after study entry, participants will receive the robot at home for two months, followed by a three month observation period without the robot. |
| Delayed/Waitlist Robot | Active comparator | Behavioral: Socially Assistive Robot for Low Vision RehabilitationThree months after study entry, participants will receive the robot at home for three months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Socially Assistive Robot for Low Vision RehabilitationA 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. | Behavioural | Delayed/Waitlist Robot, Immediate Robot |
Primary outcome
Activity Inventory
Time frame: change from 1 month post-enrollment to 2-3 months after receiving the socially assistive robot
questionnaire; scores will be Rasch analyzed in logic units with higher or positive scores indicating less difficulty (i.e., improvement)
8 secondary outcomes
MNread
Time frame: For Immediate robot: baseline, 1 month, 3 months, 6 months. For Delayed/Waitlist robot: baseline, 3 months, 6 months.
Sustained Silent Reading Test
Time frame: baseline and monthly for 6 months
Geriatric Depression Scale (GDS)
Time frame: baseline and monthly for 6 months
PANAS
Time frame: baseline and monthly for 6 months
Perceived Stress Scale
Time frame: baseline and monthly for 6 months
3-item UCLA Loneliness Scale
Time frame: baseline and monthly for 6 months
Duke Social Support Index
Time frame: baseline and monthly for 6 months
Almere
Time frame: 1 month post-enrollment and 2-3 months after receiving the socially assistive robot
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
Related trials for Low Vision
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
RecruitingPhase 4
Ocular Assessments in Patients Treated With Tivdak® in Recurrent or Metastatic Cervical Cancer
Cervical Cancer
Recruiting
Brain Stimulation Effects on Orientation and Mobility Skills in Adults With Vision Impairment
Retinitis Pigmentosa (RP), Rod Cone Dystrophy
Not yet recruiting
NEURO-COGS: Neurometabolic Mechanisms of Cognitive Training in Schizophrenia
Schizophrenia, Schizoaffective Disorder
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Tabirafusp Tedromer Compared to Aflibercept in Participants With DME - ALTO
Diabetic Macular Edema (DME)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Socially Assistive Robot for Low Vision Rehabilitation in people with Low Vision, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ava K Bittner, OD, PhD (310-206-4649, abittner@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Activity Inventory (time frame: change from 1 month post-enrollment to 2-3 months after receiving the socially assistive robot). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2024.