Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT06127316

The Effects of Heel Distraction Height on Foot Loading With Carbon Fiber Custom Dynamic Orthoses

Led by University of Iowa · Updated on 2026-01-15

20

Participants Needed

1

Research Sites

93 weeks

Total Duration

On this page

Sponsors

U

University of Iowa

Lead Sponsor

F

Fabtech Systems

Collaborating Sponsor

AI-Summary

What this Trial Is About

Carbon fiber custom dynamic orthoses (CDOs) and unloading ankle foot orthoses (AFOs) have shown varying levels of success in reducing forces acting on different regions of the bottom of the foot during gait. CDOs and unloading AFOs have shown differing offloading capabilities across different regions of the foots (hindfoot, midfoot, forefoot) which may be related to a distinct difference between CDOs and unloading AFOs: CDOs do not suspend, or distract, the foot away from the footplate. The purpose of this study is to determine the effects of CDOs and heel distraction height (the distance between the heel and the footplate) on limb loading and motion during gait as well as patient reported pain, and comfort.

CONDITIONS

Official Title

The Effects of Heel Distraction Height on Foot Loading With Carbon Fiber Custom Dynamic Orthoses

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Ages 18-65 years
  • Traumatic hindfoot injury (soft tissue injury or fracture affecting the hindfoot or ankle)
  • Mechanical pain with limb loading (≥4/10 on Numerical Pain Rating Scale)
  • Ability to walk 50 feet at a slow to moderate pace
  • Ability to walk without a cane or crutch
  • Ability to read and write in English and provide written informed consent
Not Eligible

You will not qualify if you...

  • Diagnosis with a moderate or severe brain injury
  • Diagnosis with a physical or psychological condition that would preclude functional testing (e.g., cardiac condition, clotting disorder, pulmonary condition, etc.)
  • Ankle weakness resulting from spinal cord injury or central nervous system pathology
  • Nerve, muscle, bone, or other condition limiting function in the contralateral extremity
  • Rheumatoid or inflammatory arthritis
  • Necrosis of any bones in the foot or ankle
  • Pain of 8/10 or greater during walking
  • Uncorrected visual or hearing impairments
  • Require use of a knee stabilizing device to perform daily activities (i.e., Knee ankle foot orthosis, knee orthosis, etc.)
  • Pregnancy
  • Body mass index greater than 40 kg/m2

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

4

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