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

NCT07312032 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-12-31

No results posted yet for this study

Summary

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

  • Trauma Injury

Interventions

DEVICE

Carbon Fiber Custom Dynamic Orthosis

The carbon fiber custom dynamic orthosis (CDO) used in this study will consist of a semi-rigid carbon fiber footplate, a carbon fiber posterior strut, and a proximal cuff that wraps around the leg below the knee.

DEVICE

Carbon Fiber Footplate

One or two additional full-length carbon fiber footplates will be placed under the CDO footplate to increase the effective footplate stiffness

Sponsors & Collaborators

  • University of Iowa

    collaborator OTHER

  • Jason Wilken

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-12-13
Primary Completion
2026-12-01
Completion
2027-12-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07312032 on ClinicalTrials.gov