Trauma InjuryCDOCFPlateNCT07312032
The Effects of Footplate Stiffness on Foot Loading Within Carbon Fiber Custom Dynamic Orthoses
A study testing Carbon Fiber Custom Dynamic Orthosis and Carbon Fiber Footplate in people with Trauma Injury, run by Jason Wilken at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Trauma Injury
- What is being tested?
- Carbon Fiber Custom Dynamic Orthosis and Carbon Fiber Footplate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Dec 2025to 20 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Unhealed wounds (cuts/abrasions) that would prevent AFO use
- BMI > 40
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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
- Trauma Injury
- Being tested
- Carbon Fiber Custom Dynamic Orthosis, Carbon Fiber Footplate
- Keywords
- carbon fiber, traumatic injury, ankle foot orthosis
- Medical subject headings
- Accidental Injuries, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbon Fiber Custom Dynamic OrthosisDevice
Also called ankle foot 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 FootplateDevice
One or two additional full-length carbon fiber footplates will be placed under the CDO footplate to increase the effective footplate stiffness
| Study group | Role | What they receive |
|---|---|---|
| NoCDO | No intervention | Participants will complete study activities without a CDO |
| CDO | Experimental | Participants will complete study activities while wearing a CDO with standard footplate stiffness Receives: Device: Carbon Fiber Custom Dynamic Orthosis |
| 1CFPlate | Experimental | Participants will complete study activities while wearing a CDO with standard footplate stiffness and one additional carbon fiber footplate to increase footplate stiffness Receives: Device: Carbon Fiber Custom Dynamic Orthosis; Device: Carbon Fiber Footplate |
| 2CFPlate | Experimental | Participants will complete study activities while wearing a CDO with standard footplate stiffness and two additional carbon fiber footplates to increase footplate stiffness Receives: Device: Carbon Fiber Custom Dynamic Orthosis; Device: Carbon Fiber Footplate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Forefoot Force
Plantar forces (N) will be measured across the forefoot (distal 40% of sensor).
Measured: Baseline
Forefoot Force Impulse
Plantar force impulse (Ns) across the forefoot (distal 40% of sensor) will be calculated using the integral of the force over the stance phase.
Measured: Baseline
Peak Hindfoot Force
Plantar forces (N) will be measured across the hindfoot (proximal 30% sensor).
Measured: Baseline
Hindfoot Force Impulse
Plantar force impulse (Ns) across the hindfoot (proximal 30% sensor) will be calculated using the integral of the force over the stance phase.
Measured: Baseline
Peak Ankle Power
Peak sagittal plane ankle push-off power (W/kg) during gait.
Measured: Baseline
Secondary outcomes (11)
Peak Midfoot Force
Plantar forces (N) will be measured across the midfoot (middle 30% of sensor).
Measured: Baseline
Midfoot Force Impulse
Plantar force impulse (Ns) across the midfoot (middle 30% of sensor) will be calculated using the integral of the force over the stance phase.
Measured: Baseline
Peak Total Foot Force
Plantar forces (N) will be measured across the total foot (100% of sensors).
Measured: Baseline
Total Foot Force Impulse
Plantar force impulse (Ns) across the total foot (100% of sensors) will be calculated using the integral of the force over the stance phase.
Measured: Baseline
Peak Ankle Dorsiflexion
Peak ankle dorsiflexion (degrees) during gait.
Measured: Baseline
Peak Ankle Plantarflexion
Peak ankle plantarflexion (degrees) during gait.
Measured: Baseline
Ankle Range of Motion
Range of ankle motion (degrees) during gait.
Measured: Baseline
Peak Ankle Dorsiflexion Moment
Peak ankle dorsiflexion moment (Nm/kg) during gait.
Measured: Baseline
Peak Ankle Plantarflexion Moment
Peak ankle plantarflexion moment (Nm/kg) during gait.
Measured: Baseline
Numerical Pain Rating Scale
Pain will be assessed using a standard 11-point numerical pain rating scale, in which 0 = no pain and 10 = worst pain imaginable
Measured: Baseline
Modified Socket Comfort Score (Comfort)
Comfort scores range from 0 = most uncomfortable to 10= most comfortable
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start13 Dec 2025
- Primary completion20 May 2026
- Study completion20 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jason Wilken
- Sponsor type
- University, hospital or other
- Collaborators
- University of Iowa
- Responsible party
- Sponsor-investigator, Jason Wilken, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07312032
- Sponsor's protocol ID
- 202507360
- Other IDs
- 202507360
- Acronym
- CDOCFPlate
- Status last verified
- Oct 2026
- First submitted
- 29 Dec 2025
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Footplate Stiffness on Foot Loading Within Carbon Fiber Custom Dynamic Orthoses
- ClinicalTrials.gov ID
- NCT07312032
- Acronym / sponsor ID
- CDOCFPlate / 202507360
- Conditions
- Trauma Injury
- Keywords
- carbon fiber, traumatic injury, ankle foot orthosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Jason WilkenUniversity, hospital or other
- Collaborators
- University of Iowa
- Study start
- 13 Dec 2025 (actual)
- Primary completion
- 20 May 2026 (actual)
- Study completion
- 20 May 2026 (actual)
- First posted
- 31 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| NoCDO | No intervention | –Participants will complete study activities without a CDO |
| CDO | Experimental | Device: Carbon Fiber Custom Dynamic OrthosisParticipants will complete study activities while wearing a CDO with standard footplate stiffness |
| 1CFPlate | Experimental | Device: Carbon Fiber Custom Dynamic Orthosis, Device: Carbon Fiber FootplateParticipants will complete study activities while wearing a CDO with standard footplate stiffness and one additional carbon fiber footplate to increase footplate stiffness |
| 2CFPlate | Experimental | Device: Carbon Fiber Custom Dynamic Orthosis, Device: Carbon Fiber FootplateParticipants will complete study activities while wearing a CDO with standard footplate stiffness and two additional carbon fiber footplates to increase footplate stiffness |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carbon Fiber Custom Dynamic OrthosisAlso: ankle foot orthosisThe 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 | 1CFPlate, 2CFPlate, CDO |
| Carbon Fiber FootplateOne or two additional full-length carbon fiber footplates will be placed under the CDO footplate to increase the effective footplate stiffness | Device | 1CFPlate, 2CFPlate |
Primary outcome
Peak Forefoot Force
Time frame: Baseline
Plantar forces (N) will be measured across the forefoot (distal 40% of sensor).
Forefoot Force Impulse
Time frame: Baseline
Plantar force impulse (Ns) across the forefoot (distal 40% of sensor) will be calculated using the integral of the force over the stance phase.
Peak Hindfoot Force
Time frame: Baseline
Plantar forces (N) will be measured across the hindfoot (proximal 30% sensor).
Hindfoot Force Impulse
Time frame: Baseline
Plantar force impulse (Ns) across the hindfoot (proximal 30% sensor) will be calculated using the integral of the force over the stance phase.
Peak Ankle Power
Time frame: Baseline
Peak sagittal plane ankle push-off power (W/kg) during gait.
11 secondary outcomes
Peak Midfoot Force
Time frame: Baseline
Midfoot Force Impulse
Time frame: Baseline
Peak Total Foot Force
Time frame: Baseline
Total Foot Force Impulse
Time frame: Baseline
Peak Ankle Dorsiflexion
Time frame: Baseline
Peak Ankle Plantarflexion
Time frame: Baseline
Ankle Range of Motion
Time frame: Baseline
Peak Ankle Dorsiflexion Moment
Time frame: Baseline
Peak Ankle Plantarflexion Moment
Time frame: Baseline
Numerical Pain Rating Scale
Time frame: Baseline
Modified Socket Comfort Score (Comfort)
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbon Fiber Custom Dynamic Orthosis and Carbon Fiber Footplate in people with Trauma Injury, run by Jason Wilken at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Forefoot Force (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.