Recruiting

CDOs

Sponsor:

Jason Wilken

Code:

NCT07312032

Conditions

Trauma Injury

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Carbon Fiber Custom Dynamic Orthosis

Carbon Fiber Footplate

Study Details

Brief 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

Study ID

NCT07312032

Start date

Dec 13, 2025

Status verified date

Dec, 2025

Completion date

Dec 1, 2027

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Inclusion Criteria

  • 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 their 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 CDO

Exclusion Criteria

  • Diagnosed with a moderate or severe brain injury
  • Lower extremity injury resulting in surgery or limiting function for greater than 6 weeks
  • Injuries that would limit performance in this study
  • Diagnosed with a physical or psychological condition that would preclude functional testing (e.g. cardiac condition, clotting disorder, pulmonary condition)
  • Visual or hearing impairments that limit walking ability or limit the ability to comply with instructions given during testing
  • Require use of an assistive device
  • Unhealed wounds (cuts/abrasions) that would prevent AFO use
  • BMI > 40
  • Pregnancy

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

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

Interventions

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.

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

Primary outcome measure

  • Peak Forefoot Force [ Time Frame: Baseline ]
  • Forefoot Force Impulse [ Time Frame: Baseline ]
  • Peak Hindfoot Force [ Time Frame: Baseline ]
  • Hindfoot Force Impulse [ Time Frame: Baseline ]
  • Peak Ankle Power [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Jason M Wilken, PT, PhD

+1 319 3356857jason-wilken@uiowa.edu

Kirsten M Anderson, PhD

3193530431kirsten-m-anderson@uiowa.edu

Locations

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52241

Contacts

Jason M Wilken, PT, PhD

3193356857jason-wilken@uiowa.edu

Kirsten M Anderson, PhD

3193530431kirsten-m-anderson@uiowa.edu

More Information

Sponsor

Jason Wilken

Last update posted

Dec 31, 2025

Last verified

Dec, 2025

Keywords

  • carbon fiber
  • traumatic injury
  • ankle foot orthosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Jason Wilken on 2025-12-31.