- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05888441
Obstacle Negotiation in Older People With and Without Vision Impairment
Impact of Stepping Over Obstacles of Different Contrast and Height on Gait and Eye Movements in Older Adults With and Without Vision Impairment
Study Overview
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kierstyn A Napier-Dovorany, OD
- Phone Number: 8128554426
- Email: knapier@iu.edu
Study Locations
-
-
Indiana
-
Bloomington, Indiana, United States, 47405
- Recruiting
- Indiana University
-
Contact:
- Kierstyn A Napier-Dovorany, OD
- Phone Number: 812-855-4426
- Email: knapier@iu.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
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. |
|
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.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
During a single intervention visit (Study Visit 2), up to 2-3 hours in duration.
|
|
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
|
During a single intervention visit (Study Visit 2), up to 2-3 hours in duration.
|
|
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.
|
During a single intervention visit (Study Visit 2), up to 2-3 hours in duration.
|
|
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
|
During a single intervention visit (Study Visit 2), up to 2-3 hours in duration.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16447
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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