Clinical Trial

The Effects of AFO Heel Height and Stiffness on Gait

Study acronym: AFOHeel
Recruiting
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Summary
The proposed study evaluates the effect of ankle foot orthosis (AFO) heel height and stiffness on the forces and motion of the lower limb during over-ground walking in individuals who use an AFO for daily walking. Previous studies suggest that heel height and stiffness effect limb loading, but these data and the analysis techniques applied are limited. In this study, heel cushions with different height and stiffness's (4 conditions) will be placed in participants shoes and they will walk at controlled and self-selected speeds. Participants will also walk with their AFO as configured prior to enrollment, and with no AFO if possible. The proposed study will provide evidence that can be used by clinicians and researchers to align braces that most effectively improve function during every-day walking.
Protocol Amendment History 9 amendments
This ClinicalTrials.gov record has been amended 9 times since 2021-03-11; most recent amendment 2025-12-29.
Trial Details
NCT Number NCT04800484
Lead Sponsor University of Iowa
Conditions Musculoskeletal Injury, Musculoskeletal Diseases, Peripheral Nervous System Diseases
Enrollment 40 participants
Start Date 2019-11-07
Primary Completion 2027-01-01 (estimated)
Study Completion 2027-01-01 (estimated)
Updated on ClinicalTrials.gov 2025-12-31