ClinicalTrials.gg
RecruitingNCT05888441Updated Nov 13, 2025

Obstacle Negotiation in Older People With and Without Vision Impairment

An interventional study of Obstacle characteristics in Low Vision, sponsored by Indiana University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-13.

Sponsored by Indiana University · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Started Apr 2023; still recruiting 3 years 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
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Study 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 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.

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Conditions studied

  • Low Vision

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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 200 is above the median of 60 across 78 interventional studies indexed under Vision, Low.

Browse Vision, Low studies →

Lead sponsor

Indiana University is the lead sponsor of 986 studies on the registry; 198 are open to participants now.

Of its 148 completed or terminated interventional studies of FDA-regulated products, 118 (80%) have results posted.

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

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Low Vision Group

    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.

    Other: Obstacle characteristics

  • Active comparator
    Control Group

    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.

    Other: Obstacle characteristics

Interventions

  • OtherObstacle characteristics

    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.

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What researchers measure

Primary outcomes

  1. Vertical foot clearance, lead limb

    Distance from lowest point of foot (heel or toe) to top of obstacle

    Time frame: During a single intervention visit (Study Visit 2), up to 2-3 hours in duration.

  2. Foot placement variability

    Standard deviation of position of toe to obstacle over 2-4 steps before the obstacle

    Time frame: During a single intervention visit (Study Visit 2), up to 2-3 hours in duration.

  3. Obstacle crossing speed

    Speed from lead toe off immediately before the obstacle to trail heel down immediately after the obstacle.

    Time frame: During a single intervention visit (Study Visit 2), up to 2-3 hours in duration.

  4. Gaze sequencing

    Sequence of fixations from start of trial to end of trial, normalized to the total duration and divided into 100 equal segments

    Time frame: During a single intervention visit (Study Visit 2), up to 2-3 hours in duration.

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Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2023 (actual). Primary completion is estimated for Dec 2028, 68 months after the start.

Of 38 interventional studies with no phase under Vision, Low, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 56. This study's planned 68 months is above that.

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

Registered
May 4, 2023
First posted
Jun 5, 2023
StartActual
Apr 14, 2023
Primary completionEst.
Dec 31, 2028
CompletionEst.
Dec 31, 2028
Last update
Nov 13, 2025
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 Nov 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05888441
Lead sponsor
Indiana University
Responsible party
Shirin E. Hassan (Associate Professor, Indiana University) — Principal investigator
First posted
Jun 5, 2023
Start date
Apr 14, 2023
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Nov 13, 2025

Study contacts

Kierstyn A Napier-Dovorany, OD
Contact
knapier@iu.edu
8128554426

Oversight

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

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