- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07337317
Evaluating Stairway Designs for Individuals With Vision Impairment
Frequency of Contrast Enhancement on Stairways
The goal of this study is to learn if contrast frequency on step tread-edges influences foot clearance measures, a marker of fall risk, in older adults with and without visual impairments.
The main questions that aim to be answered are how foot clearance measures change across different frequencies of stair contrast, and how experiences and perceptions of different stair contrast frequencies are evaluated.
Researchers will compare individuals with and without visual impairments to see if contrast frequency on step tread-edges changes.
Participants will attend one visit during which their vision will be measured, and they will be asked to ascend and descend laboratory stairs at different contrast frequencies.
An optional second visit will entail a focus group meeting to better understand how contrast affects mobility in their home and everyday life.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sara A Harper, PhD
- Phone Number: 2568242184
- Email: sah0075@uah.edu
Study Locations
-
-
Alabama
-
Huntsville, Alabama, United States, 35899
- Recruiting
- University of Alabama in Huntsville
-
Contact:
- Sara A Harper, PhD
- Phone Number: 2568242184
- Email: sah0075@uah.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- ≥ Contrast sensitivity log 1.6 or greater
- travels independently in the community, including stairways > two times/week
comfortable ascending and descending a stairway with rest time provided
Exclusion Criteria:
- severe rheumatologic and or orthopedic diseases (e.g., awaiting joint replacement, active inflammatory disease)
- lower-limb injuries and/or recent joint replacements (e.g., hip fracture, hip, or knee replacement within six months of study enrollment)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
All participants will participate in the experimental arm, that involves a factorial model approach inwhich all participants will experience all eight conditions.
|
Frequency of contrast marking on stair steps will be evaluated to determine how foot clearance, perceptions in older adults with and without impaired contrast sensivity
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Toe clearance
Time Frame: visit 1, through study completion, an average of 1 year
|
Toe, foot vertical clearance on stair steps
|
visit 1, through study completion, an average of 1 year
|
|
Heel clearance
Time Frame: visit 1, through study completion, an average of 1 year
|
heel, foot horizontal clearance on stair steps
|
visit 1, through study completion, an average of 1 year
|
|
Frequency of <5mm toe clearances
Time Frame: visit 1, through study completion, an average of 1 year
|
how often <5mm toe clearances occur
|
visit 1, through study completion, an average of 1 year
|
|
Frequency of <5mm heel clearances
Time Frame: visit 1, through study completion, an average of 1 year
|
how often <5mm toe clearances occur
|
visit 1, through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Likert-Scale responses of contrast marking frequency conditions
Time Frame: visit 1, through study completion, an average of 1 year
|
5-point range from strongly dislike to strongly like
|
visit 1, through study completion, an average of 1 year
|
|
Perception responses of contrast marking frequency conditions
Time Frame: visit 1, through study completion, an average of 1 year
|
Collected via auditory responses
|
visit 1, through study completion, an average of 1 year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Sara A Harper, PhD, University of Alabama in Huntsville
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 (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0011
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ANALYTIC_CODE
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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