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Obstacle Negotiation in Older People With and Without Vision Impairment

Primary Purpose

Low Vision

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Obstacle characteristics
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Low Vision

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Indiana UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Low Vision Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Vertical foot clearance, lead limb
Distance from lowest point of foot (heel or toe) to top of obstacle
Foot placement variability
Standard deviation of position of toe to obstacle over 2-4 steps before the obstacle
Obstacle crossing speed
Speed from lead toe off immediately before the obstacle to trail heel down immediately after the obstacle.
Gaze sequencing
Sequence of fixations from start of trial to end of trial, normalized to the total duration and divided into 100 equal segments

Secondary Outcome Measures

Full Information

First Posted
May 4, 2023
Last Updated
August 10, 2023
Sponsor
Indiana University
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1. Study Identification

Unique Protocol Identification Number
NCT05888441
Brief Title
Obstacle Negotiation in Older People With and Without Vision Impairment
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 14, 2023 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Vision

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low Vision Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Obstacle characteristics
Intervention Description
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.
Primary Outcome Measure Information:
Title
Vertical foot clearance, lead limb
Description
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.
Title
Foot placement variability
Description
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.
Title
Obstacle crossing speed
Description
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.
Title
Gaze sequencing
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kierstyn A Napier-Dovorany, OD
Phone
8128554426
Email
knapier@iu.edu
Facility Information:
Facility Name
Indiana University
City
Bloomington
State/Province
Indiana
ZIP/Postal Code
47405
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kierstyn A Napier-Dovorany, OD
Phone
812-855-4426
Email
knapier@iu.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Obstacle Negotiation in Older People With and Without Vision Impairment

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