Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
ID04800484

The Effects of Ankle Foot Orthosis Heel Height and Stiffness on Gait in Adults with Below-Knee Impairments

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

40

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating how the height and stiffness of the heel in ankle foot orthoses (AFOs) affect the forces and motion of the lower limbs during walking in people who regularly use an AFO. This study involves individuals with unilateral or bilateral below-knee impairments caused by musculoskeletal injury, disease, or peripheral nervous system disease. The goal is to provide evidence to help clinicians and researchers better align AFOs to improve everyday walking function. Participants will walk over ground while wearing their usual clinical AFO and with heel cushions of different heights and stiffnesses (four conditions) placed inside their shoes. They will walk at controlled and self-selected speeds, and if possible, also without their AFO. The study uses randomized testing orders of various heel wedge conditions including tall and short wedges made of soft or firm foam, as well as a no-AFO condition. During the study, lower limb forces and body motion will be measured using motion capture with small reflective markers on the skin and force plates in the floor. Participants will also provide information about their health and their preferences regarding the different heel wedge conditions. The primary outcomes include measures of center of pressure velocity, comfort, pain, and wedge preference, with additional assessments of ankle motion and power. The study is led by the University of Iowa and participation lasts across the testing sessions.

CONDITIONS

Brief 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...

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

You will not qualify if you...

  • Pain greater than 6 out of 10 while walking or pain increase of more than 2 out of 10 during testing
  • Central nervous system disorders causing lower limb spasticity (e.g., stroke, cerebral palsy, spinal cord injury)
  • Peripheral nerve diseases like diabetes or Charcot Marie Tooth (for Group 1) or limb injury-related limited function (for Group 2)
  • Use of hinged or articulating AFOs, Charcot Restraint Orthotic Walker boots, or AFOs that restrict all ankle and foot motion
  • Use of knee-crossing AFOs (knee braces)
  • Insufficient shoe space to fit the tallest heel wedge with the AFO
  • Visual or hearing impairments that limit walking ability or ability to follow instructions
  • Pregnancy
  • Body mass index over 40

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - 1 day

Participants walk over-ground with their clinically provided ankle foot orthosis (AFO) and with added heel cushions of different heights and stiffnesses, as well as without their AFO if able, to assess lower limb forces and motion using computerized motion capture and force plates.

1 visit (in-person)

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

K

Kirsten M Anderson, PhD

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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