NCT07337317

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
14mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress20%
Jan 2026Jul 2027

First Submitted

Initial submission to the registry

December 19, 2025

Completed
25 days until next milestone

First Posted

Study publicly available on registry

January 13, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

January 22, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

May 1, 2026

Status Verified

January 1, 2026

Enrollment Period

11 months

First QC Date

December 19, 2025

Last Update Submit

April 27, 2026

Conditions

Keywords

older adultsimpaired contrast sensivity

Outcome Measures

Primary Outcomes (4)

  • Toe clearance

    Toe, foot vertical clearance on stair steps

    visit 1, through study completion, an average of 1 year

  • Heel clearance

    heel, foot horizontal clearance on stair steps

    visit 1, through study completion, an average of 1 year

  • Frequency of <5mm toe clearances

    how often \<5mm toe clearances occur

    visit 1, through study completion, an average of 1 year

  • Frequency of <5mm heel clearances

    how often \<5mm toe clearances occur

    visit 1, through study completion, an average of 1 year

Secondary Outcomes (2)

  • Likert-Scale responses of contrast marking frequency conditions

    visit 1, through study completion, an average of 1 year

  • Perception responses of contrast marking frequency conditions

    visit 1, through study completion, an average of 1 year

Study Arms (1)

Intervention

EXPERIMENTAL

All participants will participate in the experimental arm, that involves a factorial model approach inwhich all participants will experience all eight conditions.

Other: Frequency of contrast marking on stair steps

Interventions

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

Intervention

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • ≥ 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama in Huntsville

Huntsville, Alabama, 35899, United States

RECRUITING

MeSH Terms

Conditions

Vision, LowMobility Limitation

Condition Hierarchy (Ancestors)

Vision DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sara A Harper, PhD

    University of Alabama in Huntsville

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara A Harper, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Four contrast frequency conditions by two lighting conditions (N = 8) will be evaluated. The four frequencies are (1) contrast markings added to all steps, (2) contrast markings added to the first, last step, (3) contrast markings added to the first, two and last, two steps, (4) no contrast markings on stairs, in both low light and standard lighting conditions
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 19, 2025

First Posted

January 13, 2026

Study Start

January 22, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

May 1, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

We will archive our deidentified metadata to the Inter-University Consortium for Political and Social Research (ICPSR).

Shared Documents
STUDY PROTOCOL, ANALYTIC CODE
Time Frame
The IDP will be made available within 6 months after publication, and will be made publicly available for 3 years.
Access Criteria
Access will be monitored through ICPSR.
More information

Locations