Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
Healthy Volunteers
NCT07312032

The Effects of Footplate Stiffness on Foot Loading Within Carbon Fiber Custom Dynamic Orthoses

Led by Jason Wilken · Updated on 2025-12-31

20

Participants Needed

1

Research Sites

102 weeks

Total Duration

On this page

Sponsors

J

Jason Wilken

Lead Sponsor

U

University of Iowa

Collaborating Sponsor

AI-Summary

What this Trial Is About

Carbon fiber custom dynamic orthoses (CDOs) improve function, reduce pain, and offload the foot and ankle. CDOs include a proximal cuff that wraps around the leg just below the knee, a posterior carbon fiber strut that bends to store and return energy, and a semi-rigid carbon fiber footplate. The purpose of this study is to determine the effect of CDO use and CDO footplate stiffness on foot loading, limb mechanics, pain, and comfort.

CONDITIONS

Official Title

The Effects of Footplate Stiffness on Foot Loading Within Carbon Fiber Custom Dynamic Orthoses

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Between the ages of 18 and 65
  • Healthy without current complaint of lower extremity pain, spine pain, open wounds or active infections, or medical or neuromusculoskeletal disorders that have limited participation in work or exercise in the last 6 months
  • Able to hop without pain
  • Able to perform a full squat without pain
  • Ability to read and write in English and provide written informed consent
  • Ability to fit in a generic sized carbon fiber custom dynamic orthosis (CDO)
Not Eligible

You will not qualify if you...

  • Diagnosed with a moderate or severe brain injury
  • Lower extremity injury resulting in surgery or limiting function for more than 6 weeks
  • Injuries that limit performance in this study
  • Diagnosed with physical or psychological conditions that prevent functional testing (e.g., cardiac, clotting, pulmonary conditions)
  • Visual or hearing impairments that limit walking ability or ability to follow instructions during testing
  • Require use of an assistive device
  • Unhealed wounds (cuts or abrasions) preventing use of an ankle-foot orthosis
  • Body mass index (BMI) over 40
  • Pregnancy

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, 52241

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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