HealthyCDOTrainNCT07889765
Comparative Effect of Training Methods to Reduce Forefoot Loading in Carbon Fiber Custom Dynamic Orthoses
A study testing Carbon Fiber Custom Dynamic Orthosis in people with Healthy, run by Jason Wilken at 1 site in United States.
Trial summary
Carbon fiber custom dynamic orthoses (CDOs) include a full-length footplate, a stiff posterior spring, and a cuff that wraps around the leg below the knee. CDOs restore function after limb trauma, decrease forefoot loading, and reduce pain. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Carbon Fiber Custom Dynamic Orthosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Ages 18-65.
- Without current complaint of lower extremity pain, spine pain, open wounds or active infection.
- Ability to hop without pain.
- Ability to perform a full squat without pain.
- Ability to read and write in English and provide written informed consent.
Who cannot join
- Diagnosis with a moderate or severe brain injury.
- Diagnosis with a physical or psychological condition that would preclude functional testing (e.g. cardiac condition, clotting disorder, pulmonary condition).
- Medical conditions or injuries that have limited participation in work or exercise in the last 6 months.
- Medical conditions of injuries limiting function for greater than 6 weeks.
- Uncorrected visual or hearing impairments.
- Use of an assistive device.
Show all 9Show fewer
- Wounds preventing CDO use
- Pregnancy
- Body mass index greater than 35 kg/m2.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Iowa
Iowa City, Iowa, 52242
Jason M Wilken, PT, PhD, 319-353-0431, jason-wilken@uiowa.edu
Kirsten M Anderson, PhD, 319-353-0431, kirsten-m-anderson@uiowa.edu
About this study
Carbon fiber custom dynamic orthoses (CDOs) include a full-length footplate, a stiff posterior spring, and a cuff that wraps around the leg below the knee. CDOs restore function after limb trauma, decrease forefoot loading, and reduce pain. However, initial introduction to a CDO is not consistent, so this study is being conducted to determine if different methods of training alter forefoot loading during gait. Unimpaired adult participants will be randomized to one of three groups: 1) no feedback, 2) visual feedback of forefoot force, and 3) visual feedback of cuff forces. All participants will walk at a controlled speed on a treadmill without the CDO, after initial introduction to the CDO, and after completing two rounds of training in the CDO.
Read the detailed description
Carbon fiber custom dynamic orthoses (CDOs) restore function for individuals with limb trauma. CDOs include a full-length footplate, a stiff posterior spring, and a proximal cuff that wraps around the leg below the knee. A key benefit of CDOs is the ability to decrease forefoot loading, which may reduce pain during walking. However, initial introduction to a CDO is not consistent and some individuals struggle to relax their lower leg muscles and rely on the CDO for support, reducing the potential offloading benefits of the CDO and increasing the risk of abandoning the CDO.
In this study we will investigate different methods of training, with or without visual feedback, to determine if training method alters forefoot loading during walking. Unimpaired adult participants will be randomized to one of three groups: 1) no feedback, 2) visual feedback of forefoot force, and 3) visual feedback of cuff forces. All participants will walk at a controlled speed on a treadmill without the CDO, after initial introduction to the CDO, and after completing two rounds of training in the CDO. Participants will complete questionnaires regarding pain and perceived CDO comfort and smoothness. Force within the CDO cuff and footplate will be measured using wireless force measuring sensors (Loadsol/Loadpad, Novel Electronics).
- Conditions
- Healthy
- Being tested
- Carbon Fiber Custom Dynamic Orthosis
- Keywords
- Carbon Fiber, Ankle Foot Orthosis, Foot Loading
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.
| Study group | Role | What they receive |
|---|---|---|
| No Visual Feedback | Experimental | Participants will walk in the study CDO without visual feedback of limb loading during gait. Receives: Device: Carbon Fiber Custom Dynamic Orthosis |
| Visual Feedback of Forefoot Force | Experimental | Participants will walk in the study CDO while being provided visual feedback of forefoot loading loading during gait. Forefoot loading will be measured using wireless insoles placed in the CDO footplate. Receives: Device: Carbon Fiber Custom Dynamic Orthosis |
| Visual Feedback of Cuff Force | Experimental | Participants will walk in the study CDO while being provided visual feedback of cuff loading loading during gait. Cuff loading will be measured using wireless insoles placed in the CDO proximal cuff. Receives: Device: Carbon Fiber Custom Dynamic Orthosis |
| NoCDO | No intervention | Participants will walk without a CDO. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Forefoot Force
Peak plantar forces, normalized to body mass (N/kg) will be measured across the forefoot (distal 40% of sensor).
Measured: Baseline
Forefoot Force Impulse
Plantar force impulse, normalized to body mass (Ns/kg) across the forefoot (distal 40% of sensor) will be calculated using the integral of the force over the stance phase.
Measured: Baseline
Secondary outcomes (6)
Peak Midfoot Force
Peak plantar forces, normalized to body mass (N/kg) will be measured across the midfoot (middle 30% of sensor).
Measured: Baseline
Midfoot Force Impulse
Plantar force impulse, normalized to body mass (Ns/kg) across the midfoot (middle 30% of sensor) will be calculated using the integral of the force over the stance phase.
Measured: Baseline
Peak Hindfoot Force
Peak plantar forces, normalized to body mass (N/kg) will be measured across the hindfoot (proximal 30% of sensor).
Measured: Baseline
Hindfoot Force Impulse
Plantar force impulse, normalized to body mass (Ns/kg) across the hindfoot (proximal 30% of sensor) will be calculated using the integral of the force over the stance phase.
Measured: Baseline
Peak Total Foot Force
Peak plantar forces, normalized to body mass (N/kg) will be measured across the total foot (100% of sensor).
Measured: Baseline
Total Foot Force Impulse
Plantar force impulse, normalized to body mass (Ns/kg) across the total foot (100% of sensor) will be calculated using the integral of the force over the stance phase.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Parallel groups
- Model description
- In this study participants will walk without a CDO (NoCDO) and then will be randomized to one of three training groups: 1) no feedback, 2) visual feedback of forefoot force, and 3) visual feedback of cuff forces. Participants will walk at a controlled speed on a treadmill without the CDO, after initial introduction to the CDO, and after completing two rounds of training in the CDO.
- Masking
- None (open label)
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jason Wilken
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jason Wilken, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07889765
- Sponsor's protocol ID
- 202605608
- Acronym
- CDOTrain
- Status last verified
- Oct 2026
- First submitted
- 16 Oct 2026
- Last updated
- 22 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 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effect of Training Methods to Reduce Forefoot Loading in Carbon Fiber Custom Dynamic Orthoses
- ClinicalTrials.gov ID
- NCT07889765
- Acronym / sponsor ID
- CDOTrain / 202605608
- Conditions
- Healthy
- Keywords
- Carbon Fiber, Ankle Foot Orthosis, Foot Loading
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Jason WilkenUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 22 Oct 2026 (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) include a full-length footplate, a stiff posterior spring, and a cuff that wraps around the leg below the knee. CDOs restore function after limb trauma, decrease forefoot loading, and reduce pain. However, initial introduction to a CDO is not consistent, so this study is being conducted to determine if different methods of training alter forefoot loading during gait. Unimpaired adult participants will be randomized to one of three groups: 1) no feedback, 2) visual feedback of forefoot force, and 3) visual feedback of cuff forces. All participants will walk at a controlled speed on a treadmill without the CDO, after initial introduction to the CDO, and after completing two rounds of training in the CDO.
Detailed description
Carbon fiber custom dynamic orthoses (CDOs) restore function for individuals with limb trauma. CDOs include a full-length footplate, a stiff posterior spring, and a proximal cuff that wraps around the leg below the knee. A key benefit of CDOs is the ability to decrease forefoot loading, which may reduce pain during walking. However, initial introduction to a CDO is not consistent and some individuals struggle to relax their lower leg muscles and rely on the CDO for support, reducing the potential offloading benefits of the CDO and increasing the risk of abandoning the CDO.
In this study we will investigate different methods of training, with or without visual feedback, to determine if training method alters forefoot loading during walking. Unimpaired adult participants will be randomized to one of three groups: 1) no feedback, 2) visual feedback of forefoot force, and 3) visual feedback of cuff forces. All participants will walk at a controlled speed on a treadmill without the CDO, after initial introduction to the CDO, and after completing two rounds of training in the CDO. Participants will complete questionnaires regarding pain and perceived CDO comfort and smoothness. Force within the CDO cuff and footplate will be measured using wireless force measuring sensors (Loadsol/Loadpad, Novel Electronics).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- In this study participants will walk without a CDO (NoCDO) and then will be randomized to one of three training groups: 1) no feedback, 2) visual feedback of forefoot force, and 3) visual feedback of cuff forces. Participants will walk at a controlled speed on a treadmill without the CDO, after initial introduction to the CDO, and after completing two rounds of training in the CDO.
| Arm | Type | Receives |
|---|---|---|
| No Visual Feedback | Experimental | Device: Carbon Fiber Custom Dynamic OrthosisParticipants will walk in the study CDO without visual feedback of limb loading during gait. |
| Visual Feedback of Forefoot Force | Experimental | Device: Carbon Fiber Custom Dynamic OrthosisParticipants will walk in the study CDO while being provided visual feedback of forefoot loading loading during gait. Forefoot loading will be measured using wireless insoles placed in the CDO footplate. |
| Visual Feedback of Cuff Force | Experimental | Device: Carbon Fiber Custom Dynamic OrthosisParticipants will walk in the study CDO while being provided visual feedback of cuff loading loading during gait. Cuff loading will be measured using wireless insoles placed in the CDO proximal cuff. |
| NoCDO | No intervention | –Participants will walk without a CDO. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ages 18-65.
- Without current complaint of lower extremity pain, spine pain, open wounds or active infection.
- Ability to hop without pain.
- Ability to perform a full squat without pain.
- Ability to read and write in English and provide written informed consent.
Key exclusion criteria (9 listed)
- Diagnosis with a moderate or severe brain injury.
- Diagnosis with a physical or psychological condition that would preclude functional testing (e.g. cardiac condition, clotting disorder, pulmonary condition).
- Medical conditions or injuries that have limited participation in work or exercise in the last 6 months.
- Medical conditions of injuries limiting function for greater than 6 weeks.
- Uncorrected visual or hearing impairments.
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 | No Visual Feedback, Visual Feedback of Cuff Force, Visual Feedback of Forefoot Force |
Primary outcome
Peak Forefoot Force
Time frame: Baseline
Peak plantar forces, normalized to body mass (N/kg) will be measured across the forefoot (distal 40% of sensor).
Forefoot Force Impulse
Time frame: Baseline
Plantar force impulse, normalized to body mass (Ns/kg) across the forefoot (distal 40% of sensor) will be calculated using the integral of the force over the stance phase.
6 secondary outcomes
Peak Midfoot Force
Time frame: Baseline
Midfoot Force Impulse
Time frame: Baseline
Peak Hindfoot Force
Time frame: Baseline
Hindfoot Force Impulse
Time frame: Baseline
Peak Total Foot Force
Time frame: Baseline
Total Foot Force Impulse
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 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.
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 in people with Healthy, 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 5 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: looking for participants now, as of the sponsor's last update on 22 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jason M Wilken, PT, PhD (319-335-6857, jason-wilken@uiowa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Forefoot Force (time frame: Baseline). The study lists 2 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 22 Oct 2026.