Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
NCT04800484

The Effects of AFO Heel Height and Stiffness on Gait

Led by University of Iowa · Updated on 2025-12-31

40

Participants Needed

1

Research Sites

373 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

The Effects of AFO Heel Height and Stiffness on Gait

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 70 years
  • Daily use of an ankle foot orthosis (AFO) for below-knee functional deficits from musculoskeletal injury, disease, or peripheral nervous system disease
  • Using current AFO for more than 2 weeks
  • Able to walk 50 feet without assistive devices
  • Able to walk at a slow to moderate pace
  • AFO fits into traditional footwear
  • Able to read and write English and provide written informed consent
Not Eligible

You will not qualify if you...

  • Pain greater than 6/10 when walking or pain increasing more than 2/10 during testing
  • Central nervous system disorders such as stroke, cerebral palsy, spinal cord injury, or conditions causing lower limb spasticity
  • Disorders affecting peripheral nerve function not related to study groups (e.g., diabetes, Charcot Marie Tooth for Group 1 exclusion)
  • Limited function in the opposite lower limb due to injury or neurological/musculoskeletal disorder
  • Use of hinged or articulating AFOs or AFOs that restrict ankle and foot motion
  • Use of AFOs that extend above the knee
  • Insufficient shoe space for the tallest heel wedge and AFO
  • Visual or hearing impairments limiting walking ability or compliance with instructions
  • Pregnancy (self-reported)
  • Body mass index greater than 40

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Iowa

Iowa City, Iowa, United States, 52242

Actively Recruiting

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Research Team

J

Jason M Wilken, PT, PhD

CONTACT

K

Kirsten M Anderson, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

OTHER

Number of Arms

24

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