Traumatic Lower Limb InjuryCDODistractNCT06127316
The Effects of Heel Distraction Height on Foot Loading With Carbon Fiber Custom Dynamic Orthoses
A study testing Carbon Fiber Custom Dynamic Orthosis (CDO) in people with Traumatic Lower Limb Injury, run by University of Iowa at 1 site in United States.
Trial summary
Carbon fiber custom dynamic orthoses (CDOs) and unloading ankle foot orthoses (AFOs) have shown varying levels of success in reducing forces acting on different regions of the bottom of the foot during gait. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Traumatic Lower Limb Injury
- What is being tested?
- Carbon Fiber Custom Dynamic Orthosis (CDO)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2024to 1 Aug 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 18-65 years
- Traumatic hindfoot injury (soft tissue injury or fracture affecting the hindfoot or ankle)
- Mechanical pain with limb loading (>=4/10 on Numerical Pain Rating Scale)
- Ability to walk 50 feet at a slow to moderate pace
- Ability to walk without a cane or crutch
- 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, etc.
- Ankle weakness resulting from spinal cord injury or central nervous system pathology
- Nerve, muscle, bone, or other condition limiting function in the contralateral extremity
- Rheumatoid or inflammatory arthritis
- Necrosis of any bones in the foot or ankle
Show all 11Show fewer
- Pain of 8/10 or greater during walking
- Uncorrected visual or hearing impairments
- Require use of a knee stabilizing device to perform daily activities (i.e., Knee ankle foot orthosis, knee orthosis, etc.)
- Pregnancy
- Body mass index greater than 40 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, 3193356857, jason-wilken@uiowa.edu
Kirsten M Anderson, PhD, 3193530431, kirsten-m-anderson@uiowa.edu
About this study
Carbon fiber custom dynamic orthoses (CDOs) and unloading ankle foot orthoses (AFOs) have shown varying levels of success in reducing forces acting on different regions of the bottom of the foot during gait. CDOs and unloading AFOs have shown differing offloading capabilities across different regions of the foots (hindfoot, midfoot, forefoot) which may be related to a distinct difference between CDOs and unloading AFOs: CDOs do not suspend, or distract, the foot away from the footplate. The purpose of this study is to determine the effects of CDOs and heel distraction height (the distance between the heel and the footplate) on limb loading and motion during gait as well as patient reported 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. 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. Unloading ankle foot orthoses (AFOs) have also been used for a number of lower extremity conditions, including traumatic injuries, in effort to reduce forces and pressure acting under the foot. Unloading AFOs have been created using many different designs, which include a proximal cuff just below the knee, a rigid strut (made of metal, plastic, etc.), and some sort of foot component (footplate, shoe, etc.).
Both CDOs and unloading AFOs have shown varying levels of success in reducing forces acting on different regions of the bottom of the foot during gait. The differences in loading may be related to a distinct difference between CDOs and unloading AFOs: CDOs do not suspend, or distract, the foot away from the footplate.
The purpose of this study is to determine the effects of CDOs and heel distraction height (the distance between the heel and the footplate) on limb loading and motion as well as patient reported pain and comfort. In this study, forces acting under the foot will be measured using wireless Loadsol insoles (Novel GMBH, St. Paul, MN) as participants walk without an orthosis (NoCDO) and with a CDO with three different posterior strut lengths resulting in three different levels of heel distraction (0cm, 1cm, 2cm) at self-selected and controlled speeds. Additionally, gait kinematic and kinetics will be measured using infrared motion capture cameras (Vicon Motion Systems Ltd., Denver, CO) and force plates (AMTI, Watertown, MA). Participants will be provided a lift for the contralateral limb to reduce the effects of leg length discrepancies during walking. Loadpad force measuring sensors (Novel GMBH, St. Paul, MN) will be used to measure forces within the CDO proximal cuff. After walking in each condition, participants will complete questionnaires concerning pain and orthosis comfort.
- Conditions
- Traumatic Lower Limb Injury
- Being tested
- Carbon Fiber Custom Dynamic Orthosis (CDO)
- Keywords
- Plantar Force, Ankle Foot Orthosis, Carbon Fiber Orthosis, Biomechanics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbon Fiber Custom Dynamic Orthosis (CDO)Device
Also called Ankle Foot Orthosis (AFO)
The carbon fiber custom dynamic orthoses (CDOs) 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. The CDO will be modular in design which will allow three carbon fiber struts of the same stiffness and differing lengths to be used to implement 0cm, 1cm, and 2cm levels of heel distraction height. A longer posterior strut will move the carbon fiber footplate away from the participants foot to create the heel distraction height.
| Study group | Role | What they receive |
|---|---|---|
| NoCDO | No intervention | Participants will complete study activities without a CDO |
| 0cm Distraction | Experimental | Participants will complete study activities while wearing a CDO with 0cm of heel distraction height Receives: Device: Carbon Fiber Custom Dynamic Orthosis (CDO) |
| 1cm Distraction | Experimental | Participants will complete study activities while wearing a CDO with 1cm of heel distraction height Receives: Device: Carbon Fiber Custom Dynamic Orthosis (CDO) |
| 2cm Distraction | Experimental | Participants will complete study activities while wearing a CDO with 2cm of heel distraction height Receives: Device: Carbon Fiber Custom Dynamic Orthosis (CDO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Force (forefoot)
Plantar forces (N) will be measured across the forefoot (distal 40% of sensor) as participants walk without a CDO and with each CDO.
Measured: Baseline
Force Impulse (forefoot)
Plantar force impulse (Ns) across the forefoot (distal 40% of sensor) will be calculated using the integral of the force over the stance phase as participants walk without a CDO and with each CDO.
Measured: Baseline
Peak Force (hindfoot)
Plantar forces (N) will be measured across the hindfoot (proximal 30% sensor) as participants walk without a CDO and with each CDO.
Measured: Baseline
Force Impulse (hindfoot)
Plantar force impulse (Ns) across the hindfoot (proximal 30% sensor) will be calculated using the integral of the force over the stance phase as participants walk without a CDO and with each CDO.
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 scores range from 0 = most uncomfortable to 10 = most comfortable, and from 0 = least smooth to 10 = most smooth
Measured: Baseline
Secondary outcomes (7)
Peak Force (total foot)
Plantar forces (N) will be measured across the total foot (100% of sensors) as participants walk without a CDO and with each CDO.
Measured: Baseline
Force Impulse (total foot)
Plantar force impulse (Ns) across the total foot (100% of sensors) will be calculated using the integral of the force over the stance phase as participants walk without a CDO and with each CDO.
Measured: Baseline
Peak Force (midfoot)
Plantar forces (N) will be measured across the midfoot (middle 30% of sensor) as participants walk without a CDO and with each CDO.
Measured: Baseline
Force Impulse (midfoot)
Plantar force impulse (Ns) across the midfoot (middle 30% of sensor) will be calculated using the integral of the force over the stance phase as participants walk without a CDO and with each CDO.
Measured: Baseline
Ankle Range of Motion
Peak ankle dorsiflexion (degrees) during gait.
Measured: Baseline
Peak Ankle Moment
Peak ankle plantarflexion moment (Nm/kg) during gait.
Measured: Baseline
Peak Ankle Power
Peak ankle push-off power (W/kg) during gait.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start16 Aug 2024
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Lower Limb InjuryStudies of the same condition, open and under way.
- More trials run by University of IowaThe sponsor's other registered studies.
- 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, forces acting under the foot (hindfoot, midfoot, forefoot, and total foot) will be measured using wireless Loadsol insoles (Novel GMBH, St. Paul, MN) as participants walk without an orthosis (NoCDO) and with a CDO with three different posterior strut lengths resulting in three different levels of heel distraction (0cm, 1cm, 2cm) at self-selected and controlled speeds. Gait kinematics and kinetics will be measured using infra-red motion capture cameras (Vicon Motion Systems Ltd., Denver, CO) and force plates (AMTI, Watertown, MA). Testing order of the CDO conditions will be randomized to prevent influence of testing order.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Collaborators
- Fabtech Systems
- Responsible party
- Principal investigator, Jason Wilken, University of Iowa
- Investigators
- Jason M Wilken, PT,PhD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06127316
- Sponsor's protocol ID
- 202302397
- Other IDs
- CDMRP-OP230037
- Acronym
- CDODistract
- Status last verified
- Oct 2026
- First submitted
- 6 Nov 2023
- Last updated
- 21 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 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Heel Distraction Height on Foot Loading With Carbon Fiber Custom Dynamic Orthoses
- ClinicalTrials.gov ID
- NCT06127316
- Acronym / sponsor ID
- CDODistract / 202302397
- Conditions
- Traumatic Lower Limb Injury
- Keywords
- Plantar Force, Ankle Foot Orthosis, Carbon Fiber Orthosis, Biomechanics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Collaborators
- Fabtech Systems
- Study start
- 16 Aug 2024 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 13 Nov 2023 (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) and unloading ankle foot orthoses (AFOs) have shown varying levels of success in reducing forces acting on different regions of the bottom of the foot during gait. CDOs and unloading AFOs have shown differing offloading capabilities across different regions of the foots (hindfoot, midfoot, forefoot) which may be related to a distinct difference between CDOs and unloading AFOs: CDOs do not suspend, or distract, the foot away from the footplate. The purpose of this study is to determine the effects of CDOs and heel distraction height (the distance between the heel and the footplate) on limb loading and motion during gait as well as patient reported 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. 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. Unloading ankle foot orthoses (AFOs) have also been used for a number of lower extremity conditions, including traumatic injuries, in effort to reduce forces and pressure acting under the foot. Unloading AFOs have been created using many different designs, which include a proximal cuff just below the knee, a rigid strut (made of metal, plastic, etc.), and some sort of foot component (footplate, shoe, etc.).
Both CDOs and unloading AFOs have shown varying levels of success in reducing forces acting on different regions of the bottom of the foot during gait. The differences in loading may be related to a distinct difference between CDOs and unloading AFOs: CDOs do not suspend, or distract, the foot away from the footplate.
The purpose of this study is to determine the effects of CDOs and heel distraction height (the distance between the heel and the footplate) on limb loading and motion as well as patient reported pain and comfort. In this study, forces acting under the foot will be measured using wireless Loadsol insoles (Novel GMBH, St. Paul, MN) as participants walk without an orthosis (NoCDO) and with a CDO with three different posterior strut lengths resulting in three different levels of heel distraction (0cm, 1cm, 2cm) at self-selected and controlled speeds. Additionally, gait kinematic and kinetics will be measured using infrared motion capture cameras (Vicon Motion Systems Ltd., Denver, CO) and force plates (AMTI, Watertown, MA). Participants will be provided a lift for the contralateral limb to reduce the effects of leg length discrepancies during walking. Loadpad force measuring sensors (Novel GMBH, St. Paul, MN) will be used to measure forces within the CDO proximal cuff. 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, forces acting under the foot (hindfoot, midfoot, forefoot, and total foot) will be measured using wireless Loadsol insoles (Novel GMBH, St. Paul, MN) as participants walk without an orthosis (NoCDO) and with a CDO with three different posterior strut lengths resulting in three different levels of heel distraction (0cm, 1cm, 2cm) at self-selected and controlled speeds. Gait kinematics and kinetics will be measured using infra-red motion capture cameras (Vicon Motion Systems Ltd., Denver, CO) and force plates (AMTI, Watertown, MA). 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 |
| 0cm Distraction | Experimental | Device: Carbon Fiber Custom Dynamic Orthosis (CDO)Participants will complete study activities while wearing a CDO with 0cm of heel distraction height |
| 1cm Distraction | Experimental | Device: Carbon Fiber Custom Dynamic Orthosis (CDO)Participants will complete study activities while wearing a CDO with 1cm of heel distraction height |
| 2cm Distraction | Experimental | Device: Carbon Fiber Custom Dynamic Orthosis (CDO)Participants will complete study activities while wearing a CDO with 2cm of heel distraction height |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ages 18-65 years
- Traumatic hindfoot injury (soft tissue injury or fracture affecting the hindfoot or ankle)
- Mechanical pain with limb loading (>=4/10 on Numerical Pain Rating Scale)
- Ability to walk 50 feet at a slow to moderate pace
- Ability to walk without a cane or crutch
Key exclusion criteria (11 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, etc.
- Ankle weakness resulting from spinal cord injury or central nervous system pathology
- Nerve, muscle, bone, or other condition limiting function in the contralateral extremity
- Rheumatoid or inflammatory arthritis
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 Orthosis (CDO)Also: Ankle Foot Orthosis (AFO)The carbon fiber custom dynamic orthoses (CDOs) 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. The CDO will be modular in design which will allow three carbon fiber struts of the same stiffness and differing lengths to be used to implement 0cm, 1cm, and 2cm levels of heel distraction height. A longer posterior strut will move the carbon fiber footplate away from the participants foot to create the heel distraction height. | Device | 0cm Distraction, 1cm Distraction, 2cm Distraction |
Primary outcome
Peak Force (forefoot)
Time frame: Baseline
Plantar forces (N) will be measured across the forefoot (distal 40% of sensor) as participants walk without a CDO and with each CDO.
Force Impulse (forefoot)
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 as participants walk without a CDO and with each CDO.
Peak Force (hindfoot)
Time frame: Baseline
Plantar forces (N) will be measured across the hindfoot (proximal 30% sensor) as participants walk without a CDO and with each CDO.
Force Impulse (hindfoot)
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 as participants walk without a CDO and with each CDO.
Numerical Pain Rating Scale
Time frame: Baseline
Pain will be assessed using a standard 11-point numerical pain rating scale, in which 0 = no pain and 10 = worst pain imaginable
Modified Socket Comfort Score
Time frame: Baseline
Comfort scores range from 0 = most uncomfortable to 10 = most comfortable, and from 0 = least smooth to 10 = most smooth
7 secondary outcomes
Peak Force (total foot)
Time frame: Baseline
Force Impulse (total foot)
Time frame: Baseline
Peak Force (midfoot)
Time frame: Baseline
Force Impulse (midfoot)
Time frame: Baseline
Ankle Range of Motion
Time frame: Baseline
Peak Ankle Moment
Time frame: Baseline
Peak Ankle Power
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 21 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.
Jason M Wilken, PT,PhD principal investigator
University of Iowa
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 (CDO) in people with Traumatic Lower Limb Injury, run by University of Iowa 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 11 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 21 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 (3193356857, 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 Force (forefoot) (time frame: Baseline). The study lists 6 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 21 Oct 2026.