MedDataX Logo

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

NCT ID: NCT07312032

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-13

Study Completion Date

2027-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Carbon fiber custom dynamic orthoses (CDOs) have been used to improve function, reduce pain, and offload the foot and ankle for individuals with a number of conditions affecting the lower extremity.\[1-3\] CDOs consist of a proximal cuff that wraps around the leg just below the knee, a posterior carbon fiber strut that bends to store and return energy during mid to late stance, a semi-rigid carbon fiber footplate, and, in some cases, a foam heel wedge placed in the shoe. Studies have previously investigated the effects of design characteristics on gait biomechanics and foot loading, however, the effect of foot plate stiffness on resulting foot loading is unknown.

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. In this study, forces acting under the foot will be measured using wireless Loadsol insoles (Novel GMBH, St. Paul, MN) and limb mechanics will be measured using motion capture cameras and force plates as participants walk without an orthosis (NoCDO), with a CDO, and with a CDO plus added carbon fiber stiffening inserts (1/2) at a controlled walking speed. Participants will be provided a heel lift for the contralateral limb to prevent leg length discrepancies during walking if necessary. After walking in each condition, participants will complete questionnaires concerning pain and orthosis comfort.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Trauma Injury

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

carbon fiber traumatic injury ankle foot orthosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

In this study participants will walk without an orthosis (NoCDO) and with a generic sized CDO with three different levels of footplate stiffness at a controlled speed (CDO, 1CFPlate, 2CFPlate). Testing order of the CDO conditions will be randomized to prevent influence of testing order.
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

NoCDO

Participants will complete study activities without a CDO

Group Type NO_INTERVENTION

No interventions assigned to this group

CDO

Participants will complete study activities while wearing a CDO with standard footplate stiffness

Group Type EXPERIMENTAL

Carbon Fiber Custom Dynamic Orthosis

Intervention Type 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.

1CFPlate

Participants will complete study activities while wearing a CDO with standard footplate stiffness and one additional carbon fiber footplate to increase footplate stiffness

Group Type EXPERIMENTAL

Carbon Fiber Custom Dynamic Orthosis

Intervention Type 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

Intervention Type DEVICE

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

2CFPlate

Participants will complete study activities while wearing a CDO with standard footplate stiffness and two additional carbon fiber footplates to increase footplate stiffness

Group Type EXPERIMENTAL

Carbon Fiber Custom Dynamic Orthosis

Intervention Type 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

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

ankle foot orthosis

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Jason Wilken

OTHER

Sponsor Role lead

University of Iowa

OTHER

Sponsor Role collaborator

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jason Wilken

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Iowa

Iowa City, Iowa, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jason M Wilken, PT, PhD

Role: CONTACT

Phone: +1 319 3356857

Email: [email protected]

Kirsten M Anderson, PhD

Role: CONTACT

Phone: 3193530431

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jason M Wilken, PT, PhD

Role: primary

Kirsten M Anderson, PhD

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

202507360

Identifier Type: OTHER

Identifier Source: secondary_id

202507360

Identifier Type: -

Identifier Source: org_study_id