Low VisionNCT05888441
Obstacle Negotiation in Older People With and Without Vision Impairment
A study testing Obstacle characteristics in people with Low Vision, run by Indiana University at 1 site in United States.
Trial summary
Falls are common among people with vision impairment and can lead to devastating health consequences. Understanding the functions of vision and how the visual characteristics of obstacles in the walking path impact the gait of people with vision impairment is necessary to create strategies to prevent falls in this… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Low Vision
- What is being tested?
- Obstacle characteristics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2023to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 or over
- Able to walk independently
- Either have normal vision, or impaired vision.
- Impaired vision is defined as binocular visual acuity of 20/25 or worse with or without a central scotoma; and/or binocular visual field that is restricted to an average of 100 degrees in diameter or less
- Control subjects will have visual acuity of 20/40 or better.
Who cannot join
- Not cleared by a medical provider for moderate physical activity
- Self-report or have a history of: vestibular disorder or deafness
- Medical history of any condition that affects the ability to walk for up to 2 hours with breaks, such as feeling dizzy or faint, chest pain, palpitations, pain or numbness in the legs, shortness of breath,
- Cognitive limitations either by self-report or a score on the Mini Mental State Exam below 24 (out of 30)
- Walking or gait abnormalities, such as those caused from an injury, surgery, severe arthritis, or neurological condition such as Parkinson's disease
- Unable to walk without any walking aids such as a walker, cane, guide dog, or oxygen tank.
- Does not speak English
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Indiana University
Bloomington, Indiana, 47405
Kierstyn A Napier-Dovorany, OD, 812-855-4426, knapier@iu.edu
About this study
Official title: Impact of Stepping Over Obstacles of Different Contrast and Height on Gait and Eye Movements in Older Adults With and Without Vision Impairment
Falls are common among people with vision impairment and can lead to devastating health consequences. Understanding the functions of vision and how the visual characteristics of obstacles in the walking path impact the gait of people with vision impairment is necessary to create strategies to prevent falls in this population. The purpose of this study is to determine how adults with vision impairment change their gait behavior when stepping over obstacles that vary in height and contrast to the ground. We will then determine the mechanisms of gaze behavior that correlate to the gait behavior.
- Conditions
- Low Vision
- Being tested
- Obstacle characteristics
- Medical subject headings
- Vision, Low
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obstacle characteristicsOther
In the walking trials, when an obstacle is present, the obstacle height and obstacle contrast level will be varied across the trial repetitions.
Each participant will be exposed to obstacles of two heights: the first will be 1 centimeter in height, and the second will be approximately 20% of the subject's leg length (ranging in physical height between 15 - 22 centimeters to cover a range of leg lengths in the population).
Obstacles (of both heights) will also be painted such that their measured luminance (or contrast) level against the floor luminance is varied. High contrast obstacles will have ≥80% Michelson contrast and low contrast obstacles will have ≤30% Michelson contrast.
| Study group | Role | What they receive |
|---|---|---|
| Low Vision Group | Experimental | At a single study visit, the group of low vision participants will be asked to perform a series of short walking trials. During each trial they will walk at a self-selected speed along a walkway (6 meters in length) that may or may not contain an obstacle to step over. The trials will be randomly varied with regard to an obstacle's presence, height, and contrast from the walkway surface. Repeated trials of each condition variation will be performed during the visit. Receives: Other: Obstacle characteristics |
| Control Group | Active comparator | At a single study visit, the group of age-matched participants without low vision will be asked to perform a series of short walking trials. During each trial they will walk at a self-selected speed along a walkway (6 meters in length) that may or may not contain an obstacle to step over. The trials will be randomly varied with regard to an obstacle's presence, height, and contrast from the walkway surface. Repeated trials of each condition variation will be performed during the visit. Receives: Other: Obstacle characteristics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vertical foot clearance, lead limb
Distance from lowest point of foot (heel or toe) to top of obstacle
Measured: During a single intervention visit (Study Visit 2), up to 2-3 hours in duration.
Foot placement variability
Standard deviation of position of toe to obstacle over 2-4 steps before the obstacle
Measured: During a single intervention visit (Study Visit 2), up to 2-3 hours in duration.
Obstacle crossing speed
Speed from lead toe off immediately before the obstacle to trail heel down immediately after the obstacle.
Measured: During a single intervention visit (Study Visit 2), up to 2-3 hours in duration.
Gaze sequencing
Sequence of fixations from start of trial to end of trial, normalized to the total duration and divided into 100 equal segments
Measured: During a single intervention visit (Study Visit 2), up to 2-3 hours in duration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start14 Apr 2023
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (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 Indiana UniversityThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shirin E. Hassan, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05888441
- Sponsor's protocol ID
- 16447
- Status last verified
- Nov 2025
- First submitted
- 4 May 2023
- Last updated
- 13 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Stepping Over Obstacles of Different Contrast and Height on Gait and Eye Movements in Older Adults With and Without Vision Impairment
- ClinicalTrials.gov ID
- NCT05888441
- Acronym / sponsor ID
- 16447
- Conditions
- Low Vision
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 14 Apr 2023 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 5 Jun 2023 (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.
Falls are common among people with vision impairment and can lead to devastating health consequences. Understanding the functions of vision and how the visual characteristics of obstacles in the walking path impact the gait of people with vision impairment is necessary to create strategies to prevent falls in this population. The purpose of this study is to determine how adults with vision impairment change their gait behavior when stepping over obstacles that vary in height and contrast to the ground. We will then determine the mechanisms of gaze behavior that correlate to the gait behavior.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Vision Group | Experimental | Other: Obstacle characteristicsAt a single study visit, the group of low vision participants will be asked to perform a series of short walking trials. During each trial they will walk at a self-selected speed along a walkway (6 meters in length) that may or may not contain an obstacle to step over. The trials will be randomly varied with regard to an obstacle's presence, height, and contrast from the walkway surface. Repeated trials of each condition variation will be performed during the visit. |
| Control Group | Active comparator | Other: Obstacle characteristicsAt a single study visit, the group of age-matched participants without low vision will be asked to perform a series of short walking trials. During each trial they will walk at a self-selected speed along a walkway (6 meters in length) that may or may not contain an obstacle to step over. The trials will be randomly varied with regard to an obstacle's presence, height, and contrast from the walkway surface. Repeated trials of each condition variation will be performed during the visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 or over
- Able to walk independently
- Either have normal vision, or impaired vision.
Key exclusion criteria (7 listed)
- Not cleared by a medical provider for moderate physical activity
- Self-report or have a history of: vestibular disorder or deafness
- Medical history of any condition that affects the ability to walk for up to 2 hours with breaks, such as feeling dizzy or faint, chest pain, palpitations, pain or numbness in the legs, shortness of breath,
- Cognitive limitations either by self-report or a score on the Mini Mental State Exam below 24 (out of 30)
- Walking or gait abnormalities, such as those caused from an injury, surgery, severe arthritis, or neurological condition such as Parkinson's disease
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 |
|---|---|---|
| Obstacle characteristicsIn the walking trials, when an obstacle is present, the obstacle height and obstacle contrast level will be varied across the trial repetitions. Each participant will be exposed to obstacles of two heights: the first will be 1 centimeter in height, and the second will be approximately 20% of the subject's leg length (ranging in physical height between 15 - 22 centimeters to cover a range of leg lengths in the population). Obstacles (of both heights) will also be painted such that their measured luminance (or contrast) level against the floor luminance is varied. High contrast obstacles will have ≥80% Michelson contrast and low contrast obstacles will have ≤30% Michelson contrast. | Other | Control Group, Low Vision Group |
Primary outcome
Vertical foot clearance, lead limb
Time frame: During a single intervention visit (Study Visit 2), up to 2-3 hours in duration.
Distance from lowest point of foot (heel or toe) to top of obstacle
Foot placement variability
Time frame: During a single intervention visit (Study Visit 2), up to 2-3 hours in duration.
Standard deviation of position of toe to obstacle over 2-4 steps before the obstacle
Obstacle crossing speed
Time frame: During a single intervention visit (Study Visit 2), up to 2-3 hours in duration.
Speed from lead toe off immediately before the obstacle to trail heel down immediately after the obstacle.
Gaze sequencing
Time frame: During a single intervention visit (Study Visit 2), up to 2-3 hours in duration.
Sequence of fixations from start of trial to end of trial, normalized to the total duration and divided into 100 equal segments
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Obstacle characteristics in people with Low Vision, run by Indiana University 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 5 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 13 Nov 2025. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kierstyn A Napier-Dovorany, OD (8128554426, knapier@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vertical foot clearance, lead limb (time frame: During a single intervention visit (Study Visit 2), up to 2-3 hours in duration.). The study lists 4 primary outcomes in all. 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 13 Nov 2025.