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

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
Jason Wilken
Study ID
NCT07312032
Status
Recruiting
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Conditions

  • Trauma Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Carbon Fiber Custom Dynamic Orthosis — DEVICE
    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.
  • Carbon Fiber Footplate — DEVICE
    One or two additional full-length carbon fiber footplates will be placed under the CDO footplate to increase the effective footplate stiffness

Study Details

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.

Key Dates

Start date
Dec 13, 2025
Status verified
Dec 2025
Primary completion
Dec 1, 2026
Completion
Dec 1, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • No Intervention: NoCDO
    Participants will complete study activities without a CDO
  • Experimental: CDO
    Participants will complete study activities while wearing a CDO with standard footplate stiffness
  • Experimental: 1CFPlate
    Participants will complete study activities while wearing a CDO with standard footplate stiffness and one additional carbon fiber footplate to increase footplate stiffness
  • Experimental: 2CFPlate
    Participants will complete study activities while wearing a CDO with standard footplate stiffness and two additional carbon fiber footplates to increase footplate stiffness

Primary Outcome Measure

Peak Forefoot Force [ Time Frame: Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of IowaIowa CityIowa52241
Jason M Wilken, PT, PhD
[email protected]
3193356857
Kirsten M Anderson, PhD
[email protected]
3193530431

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By research site
University of Iowa· Iowa City, IA

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