Ankle FracturesPRMRP-FPA2NCT04562896
Iterative Design of Custom Dynamic Orthoses to Reduce Articular Contact Stress
A study testing Custom Carbon Fiber Dynamic Orthosis (CDO) in people with Ankle Fractures and Post-traumatic Osteoarthritis, run by University of Iowa at 1 site in United States.
Trial summary
The proposed study evaluates the effect of carbon fiber brace design on forces across the ankle joint. Research suggests that ankle arthritis develops after ankle fracture, in part, due to elevated forces on the cartilage. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Ankle Fractures, Post-traumatic Osteoarthritis, Osteoarthritis Ankle
- What is being tested?
- Custom Carbon Fiber Dynamic Orthosis (CDO)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2020to 5 Oct 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Sustained unilateral fracture of the tibial pilon within the preceding 5 years
- The fracture has completely healed
- Ability to walk 50 feet without use of an assistive device (cane, crutch, etc.)
- Ability to walk at a slow to moderate pace
- Shoe size between women's 8 and 13.5 or men's 6.5 and 13
- Ability to read and write in English and provide written informed consent
- Individuals with elevated contact stress according to model generated using PedCAT standing CT images (will be answered after completing visit one)
Who cannot join
- Pain > 6/10 while walking
- Increase in pain during testing of 3/10 or greater
- Neurologic, musculoskeletal (including bilateral fractures) or other condition limiting function of the contralateral extremity
- Medical or psychological condition that would preclude functional testing (ex. moderate or severe brain injury, stroke, heart disease)
- Wounds to the calf that would prevent CDO fitting
- Fractures secondary to neuropathy or severe osteopenia
Show all 31Show fewer
- Classification as non-ambulatory
- Previous fractures near the tibial pilon on the involved limb
- Surgery on involved limb anticipated in the next 6 months
- Requirement of a knee stabilizing device (i.e. KAFO, KO…) to perform daily activities
- Visual or hearing impairments that limit walking ability or limit the ability to comply with instructions given during testing
- BMI greater than 40
- Pregnancy- Per participant self-report. Due to the expected small number of pregnant individuals and resulting inability to account for its effect on resulting outcomes, participants will be withdrawn from the study.
- HEALTHY ABLE-BODIED PARTICIPANTS:
- Patient Inclusion Criteria
- Between the ages of 18 and 65
- Shoe size between women's 8 and 13.5 or men's 6.5 and 13
- Healthy individuals without a current complaint of lower extremity pain, spine pain, or medical or neuromusculoskeletal disorders that have limited participation in work or exercise in the last 6 months
- Full active range of motion of the bilateral lower extremities and spine
- 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
- Patient Exclusion Criteria
- Diagnosed moderate or severe brain injury
- Prior lower extremity injury resulting in surgery or limiting function for greater than 6 weeks
- Diagnosis of a physical or psychological condition that would preclude testing (e.g. cardiac condition, clotting disorder, pulmonary condition)
- Visual or hearing impairment that would interfere with instructions given during testing
- Require an assistive device
- Wounds to the foot or calf that would prevent CDO use
- BMI greater than 40
- Pregnancy - Per participant self-report. Due to the expected small number of pregnant individuals and resulting inability to account for its effect on resulting outcomes, participants will be withdrawn from the study
Trial locations and contacts
1 site in 1 country.
About this study
The proposed study evaluates the effect of carbon fiber brace design on forces across the ankle joint. Research suggests that ankle arthritis develops after ankle fracture, in part, due to elevated forces on the cartilage. It is expected that carbon fiber braces can be designed to reduce forces in the ankle joint and thereby reduce the risk of developing arthritis following traumatic injury. In this study, brace geometry will be varied to determine how these changes influence the forces experienced by ankle cartilage. The proposed study will provide evidence that can be used by clinicians and researchers to design braces that most effectively reduce forces on ankle cartilage.
Read the detailed description
The primary purpose of this line of research is to investigate the effects of carbon fiber custom dynamic orthosis (CDO) design on the forces and contact stress at the ankle, with the goal of reducing the development of post traumatic osteoarthritis (PTOA) in the ankle. Research suggests that ankle arthritis develops, in part, due to increased contact stresses within the ankle joint following fracture. It is expected that reducing articular contact stress at the ankle has the potential to delay or prevent the development of PTOA. CDOs have been shown to significantly improve function following extremity injury, and show promise for offloading the injured limb after severe lower extremity injuries. Therefore, the proposed effort is designed to evaluate how different CDO design factors influence offloading and therefore the reduction of forces and articular contact stress at the ankle.
Adult participants will be evaluated while wearing carbon fiber braces of varied geometry. The primary dependent measure is ankle joint contact stress. Following consent and enrollment computerized tomography (CT) images will be used to determine the geometry of the joint articular surfaces. Ankle contact stress will be calculated using discrete element analysis and biomechanical data collected in subsequent data collection.
Participants will be cast and fit for three CDOs with varied geometry. Participants will be blinded to the design variation of each device and will only know them as CDO-A, CDO-B, or CDO-C. Testing will be completed under 4 conditions: No-CDO, CDO-A, CDO-B, CDO-C, with each bracing condition (A/B/C) representing a CDO design variant. Physical performance measures will incorporate tests of agility, speed, and lower limb power to ensure that changes to device design do not negatively affect physical function. Questionnaires will be used to evaluate participants' current and desired activity level, pain with and without CDO use, satisfaction with the devices, perception of comfort and smoothness between devices, and preference between CDOs. Semi-structured interviews will be completed to fully capture the participant's perspective. Lower limb forces and motion will be assessed using a computerized motion capture system and force plates in the floor. Forces between the foot and CDO will be measured using force sensing insoles, and muscle activity data will be collected using surface electromyography. Devices will be mechanically tested, and participant demographic and anthropometric data will be recorded.
- Being tested
- Custom Carbon Fiber Dynamic Orthosis (CDO)
- Keywords
- Carbon Fiber, Gait Analysis, Ankle Foot Orthosis, Arthritis, Biomechanics, Ankle, Adult
- Medical subject headings
- Ankle Fractures, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Custom Carbon Fiber Dynamic Orthosis (CDO)Device
Also called Ankle Foot Orthosis
The custom carbon fiber dynamic orthoses will consist of a semi-rigid foot plate, a posterior carbon fiber strut, and a proximal cuff below the knee.
| Study group | Role | What they receive |
|---|---|---|
| No Device | No intervention | Participants will be evaluated without a CDO. |
| CDO-A | Experimental | The first design variant will be designated CDO-A Receives: Device: Custom Carbon Fiber Dynamic Orthosis (CDO) |
| CDO-B | Experimental | The second design variant will be designated CDO-B Receives: Device: Custom Carbon Fiber Dynamic Orthosis (CDO) |
| CDO-C | Experimental | The third design variant will be designated CDO-C Receives: Device: Custom Carbon Fiber Dynamic Orthosis (CDO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Joint Contact Stress Time Exposure (Model Estimated)
Joint contact stress time exposure (MPA-s/gait cycle) was estimated using a participant specific musculoskeletal model. Peak joint contact stress time exposure (MPA-s/gait cycle) acting on the tibia during the gait cycle were reported. Lower peak contact stress time exposure is considered a better outcome.
Measured: Baseline
Peak Plantar Force (Total Foot)
Plantar forces normalized to body weight (N/kg) will be measured across the forefoot (100% of sensor) and normalized to participant body weight as they walk.
Measured: Baseline
Peak Plantar Force (Hindfoot)
Plantar forces normalized to body weight (N/kg) will be measured across the forefoot (proximal 30% of sensor) as participants walk without a CDO and with each CDO.
Measured: Baseline
Peak Plantar Force (Midfoot)
Plantar forces normalized to body weight (N/kg) will be measured across the forefoot (middle 30% of sensor) as participants walk without a CDO and with each CDO.
Measured: Baseline
Peak Plantar Force (Forefoot)
Plantar forces normalized to body weight (N/kg) will be measured across the forefoot (distal 40% of sensor) as participants walk without a CDO and with each CDO.
Measured: Baseline
Plantar Force Impulse (Total Foot)
Plantar force impulse normalized to body weight (Ns/kg) across the forefoot (100% of sensor) will be calculated using the integral of the force over the stance phase and normalized to participant body weight as they walk.
Measured: Baseline
Plantar Force Impulse (Hindfoot)
Plantar force impulse normalized to body weight (Ns/kg) across the forefoot (proximal 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
Plantar Force Impulse (Midfoot)
Plantar force impulse normalized to body weight (Ns/kg) across the forefoot (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
Plantar Force Impulse (Forefoot)
Plantar force impulse normalized to body weight (Ns/kg) 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
Numerical Pain Rating Scale (Before Performance Measures - 4SST, 5STS)
Pain will be assessed using a standard 11-point numerical pain rating scale, in which 0 = no pain and 10 = worst pain imaginable. Lower values are better as they indicate less pain.
Measured: Baseline
Numerical Pain Rating Scale (After Performance Measures - 4SST, 5STS)
Pain will be assessed using a standard 11-point numerical pain rating scale, in which 0 = no pain and 10 = worst pain imaginable. Lower values are better as they indicate less pain
Measured: Baseline
Participant Device Preference (Rank Order NoCDO, CDOA, CDOB, CDOC)
The participant will rank order their preference for their standard of care device (if applicable), No Device, CDO-A, CDO-B, CDO-C on a questionnaire.
Measured: Baseline
Participant Device Preference (First Preferred Condition)
Participants were asked to rank order their preference for NoCDO, CDO-A, CDO-B, CDO-C on a questionnaire.
Measured: Baseline
Participant Device Preference (Second Preferred Condition)
Participants were asked to rank order the testing conditions from the condition they would most prefer to walk in everyday (first preferred) to the condition they would least prefer to walk in everyday (fourth preferred).
Measured: Baseline
Participant Device Preference (Third Preferred Condition)
Participants were asked to rank order the testing conditions from the condition they would most prefer to walk in everyday (first preferred) to the condition they would least prefer to walk in everyday (fourth preferred).
Measured: Baseline
Participant Device Preference (Fourth Preferred Condition)
Participants were asked to rank order the testing conditions from the condition they would most prefer to walk in everyday (first preferred) to the condition they would least prefer to walk in everyday (fourth preferred).
Measured: Baseline
Secondary outcomes (10)
Peak Soleus Muscle Force (Model Estimated)
Peak soleus muscle force (N) during gait was estimated using a participant specific musculoskeletal model.
Measured: Baseline
Peak Gastrocnemius Muscle Force (Model Estimated)
Peak gastrocnemius muscle force (N) during gait was estimated using a participant specific musculoskeletal model.
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
Four Square Step Test (4SST)
The 4SST (s) is a standardized timed test of balance and agility. One inch pipe is placed on the floor in the shape of a Maltese cross and participants are instructed to begin in the back left quadrant then to move 1) forward, 2) sideways right, 3) backward, then 4) sideways left, then to move in the reverse direction back to the original square.
Measured: Baseline
Sit to Stand 5 Times (STS5)
STS5 (s) is a well-established timed measure of lower limb muscle strength and power. Participants are instructed to start the test sitting with their arms folded across their chest and with their back against a standard chair. Patients are then instructed to stand up and sit down 5 times as fast as possible, avoiding touching their back to the chair during each repetition. The time to complete all five continuous repetitions is reported.
Measured: Baseline
The Orthotics Prosthetics Users' Survey (OPUS)
Satisfaction with device will be assessed using the Orthotics Prosthetics Users' Survey Satisfaction With Device Score (11-55). Lower scores indicate a better outcome.
Measured: Baseline
Modified Socket Comfort Score (Comfort)
Comfort scores range from 0 = most uncomfortable to 10 = most comfortable. Higher scores are better as they indicate a more comfortable device.
Measured: Baseline
Modified Socket Comfort Score (Smoothness)
Comfort scores range from 0 = least smooth to 10 = most smooth. Higher scores are better as they indicate a smoother rollover with the device.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start8 Jan 2020
- Primary completion5 Oct 2023
- Study completion5 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ankle FracturesStudies 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
- All participants will be cast and fit with three carbon fiber custom dynamic orthoses (CDOs). Each CDO will differ from the others in design and will be labeled as CDO-A, CDO-B and CDO-C. Participants will be randomly assigned to one of six CDO testing sequences (ABC, ACB, BCA, BAC, CAB, CBA) to prevent testing order from influencing study results. Multiple rounds of evaluation (\~5 rounds) with small groups of participants in each round (n=\~6) will be used.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Collaborators
- University of Delaware, Bio-Mechanical Composites, 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
- NCT04562896
- Sponsor's protocol ID
- 202002769
- Other IDs
- CDMRP-PR172087
- Acronym
- PRMRP-FPA2
- Status last verified
- Apr 2025
- First submitted
- 31 Aug 2020
- Last updated
- 30 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iterative Design of Custom Dynamic Orthoses to Reduce Articular Contact Stress
- ClinicalTrials.gov ID
- NCT04562896
- Acronym / sponsor ID
- PRMRP-FPA2 / 202002769
- Keywords
- Carbon Fiber, Gait Analysis, Ankle Foot Orthosis, Arthritis, Biomechanics, Ankle, Adult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Collaborators
- University of Delaware, Bio-Mechanical Composites, Fabtech Systems
- Study start
- 8 Jan 2020 (actual)
- Primary completion
- 5 Oct 2023 (actual)
- Study completion
- 5 Oct 2023 (actual)
- First posted
- 24 Sep 2020 (actual)
- Results
- Posted 23 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed study evaluates the effect of carbon fiber brace design on forces across the ankle joint. Research suggests that ankle arthritis develops after ankle fracture, in part, due to elevated forces on the cartilage. It is expected that carbon fiber braces can be designed to reduce forces in the ankle joint and thereby reduce the risk of developing arthritis following traumatic injury. In this study, brace geometry will be varied to determine how these changes influence the forces experienced by ankle cartilage. The proposed study will provide evidence that can be used by clinicians and researchers to design braces that most effectively reduce forces on ankle cartilage.
Detailed description
The primary purpose of this line of research is to investigate the effects of carbon fiber custom dynamic orthosis (CDO) design on the forces and contact stress at the ankle, with the goal of reducing the development of post traumatic osteoarthritis (PTOA) in the ankle. Research suggests that ankle arthritis develops, in part, due to increased contact stresses within the ankle joint following fracture. It is expected that reducing articular contact stress at the ankle has the potential to delay or prevent the development of PTOA. CDOs have been shown to significantly improve function following extremity injury, and show promise for offloading the injured limb after severe lower extremity injuries. Therefore, the proposed effort is designed to evaluate how different CDO design factors influence offloading and therefore the reduction of forces and articular contact stress at the ankle.
Adult participants will be evaluated while wearing carbon fiber braces of varied geometry. The primary dependent measure is ankle joint contact stress. Following consent and enrollment computerized tomography (CT) images will be used to determine the geometry of the joint articular surfaces. Ankle contact stress will be calculated using discrete element analysis and biomechanical data collected in subsequent data collection.
Participants will be cast and fit for three CDOs with varied geometry. Participants will be blinded to the design variation of each device and will only know them as CDO-A, CDO-B, or CDO-C. Testing will be completed under 4 conditions: No-CDO, CDO-A, CDO-B, CDO-C, with each bracing condition (A/B/C) representing a CDO design variant. Physical performance measures will incorporate tests of agility, speed, and lower limb power to ensure that changes to device design do not negatively affect physical function. Questionnaires will be used to evaluate participants' current and desired activity level, pain with and without CDO use, satisfaction with the devices, perception of comfort and smoothness between devices, and preference between CDOs. Semi-structured interviews will be completed to fully capture the participant's perspective. Lower limb forces and motion will be assessed using a computerized motion capture system and force plates in the floor. Forces between the foot and CDO will be measured using force sensing insoles, and muscle activity data will be collected using surface electromyography. Devices will be mechanically tested, and participant demographic and anthropometric data will be recorded.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- All participants will be cast and fit with three carbon fiber custom dynamic orthoses (CDOs). Each CDO will differ from the others in design and will be labeled as CDO-A, CDO-B and CDO-C. Participants will be randomly assigned to one of six CDO testing sequences (ABC, ACB, BCA, BAC, CAB, CBA) to prevent testing order from influencing study results. Multiple rounds of evaluation (~5 rounds) with small groups of participants in each round (n=~6) will be used.
| Arm | Type | Receives |
|---|---|---|
| No Device | No intervention | –Participants will be evaluated without a CDO. |
| CDO-A | Experimental | Device: Custom Carbon Fiber Dynamic Orthosis (CDO)The first design variant will be designated CDO-A |
| CDO-B | Experimental | Device: Custom Carbon Fiber Dynamic Orthosis (CDO)The second design variant will be designated CDO-B |
| CDO-C | Experimental | Device: Custom Carbon Fiber Dynamic Orthosis (CDO)The third design variant will be designated CDO-C |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Ages: 18-65
- Sustained unilateral fracture of the tibial pilon within the preceding 5 years
- The fracture has completely healed
- Ability to walk 50 feet without use of an assistive device (cane, crutch, etc.)
- Ability to walk at a slow to moderate pace
Key exclusion criteria (31 listed)
- Pain > 6/10 while walking
- Increase in pain during testing of 3/10 or greater
- Neurologic, musculoskeletal (including bilateral fractures) or other condition limiting function of the contralateral extremity
- Medical or psychological condition that would preclude functional testing (ex. moderate or severe brain injury, stroke, heart disease)
- Wounds to the calf that would prevent CDO fitting
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 |
|---|---|---|
| Custom Carbon Fiber Dynamic Orthosis (CDO)Also: Ankle Foot OrthosisThe custom carbon fiber dynamic orthoses will consist of a semi-rigid foot plate, a posterior carbon fiber strut, and a proximal cuff below the knee. | Device | CDO-A, CDO-B, CDO-C |
Primary outcome
Joint Contact Stress Time Exposure (Model Estimated)
Time frame: Baseline
Joint contact stress time exposure (MPA-s/gait cycle) was estimated using a participant specific musculoskeletal model. Peak joint contact stress time exposure (MPA-s/gait cycle) acting on the tibia during the gait cycle were reported. Lower peak contact stress time exposure is considered a better outcome.
Peak Plantar Force (Total Foot)
Time frame: Baseline
Plantar forces normalized to body weight (N/kg) will be measured across the forefoot (100% of sensor) and normalized to participant body weight as they walk.
Peak Plantar Force (Hindfoot)
Time frame: Baseline
Plantar forces normalized to body weight (N/kg) will be measured across the forefoot (proximal 30% of sensor) as participants walk without a CDO and with each CDO.
Peak Plantar Force (Midfoot)
Time frame: Baseline
Plantar forces normalized to body weight (N/kg) will be measured across the forefoot (middle 30% of sensor) as participants walk without a CDO and with each CDO.
Peak Plantar Force (Forefoot)
Time frame: Baseline
Plantar forces normalized to body weight (N/kg) will be measured across the forefoot (distal 40% of sensor) as participants walk without a CDO and with each CDO.
Plantar Force Impulse (Total Foot)
Time frame: Baseline
Plantar force impulse normalized to body weight (Ns/kg) across the forefoot (100% of sensor) will be calculated using the integral of the force over the stance phase and normalized to participant body weight as they walk.
Plantar Force Impulse (Hindfoot)
Time frame: Baseline
Plantar force impulse normalized to body weight (Ns/kg) across the forefoot (proximal 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.
Plantar Force Impulse (Midfoot)
Time frame: Baseline
Plantar force impulse normalized to body weight (Ns/kg) across the forefoot (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.
Plantar Force Impulse (Forefoot)
Time frame: Baseline
Plantar force impulse normalized to body weight (Ns/kg) 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.
Numerical Pain Rating Scale (Before Performance Measures - 4SST, 5STS)
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. Lower values are better as they indicate less pain.
Numerical Pain Rating Scale (After Performance Measures - 4SST, 5STS)
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. Lower values are better as they indicate less pain
Participant Device Preference (Rank Order NoCDO, CDOA, CDOB, CDOC)
Time frame: Baseline
The participant will rank order their preference for their standard of care device (if applicable), No Device, CDO-A, CDO-B, CDO-C on a questionnaire.
Participant Device Preference (First Preferred Condition)
Time frame: Baseline
Participants were asked to rank order their preference for NoCDO, CDO-A, CDO-B, CDO-C on a questionnaire.
Participant Device Preference (Second Preferred Condition)
Time frame: Baseline
Participants were asked to rank order the testing conditions from the condition they would most prefer to walk in everyday (first preferred) to the condition they would least prefer to walk in everyday (fourth preferred).
Participant Device Preference (Third Preferred Condition)
Time frame: Baseline
Participants were asked to rank order the testing conditions from the condition they would most prefer to walk in everyday (first preferred) to the condition they would least prefer to walk in everyday (fourth preferred).
Participant Device Preference (Fourth Preferred Condition)
Time frame: Baseline
Participants were asked to rank order the testing conditions from the condition they would most prefer to walk in everyday (first preferred) to the condition they would least prefer to walk in everyday (fourth preferred).
10 secondary outcomes
Peak Soleus Muscle Force (Model Estimated)
Time frame: Baseline
Peak Gastrocnemius Muscle Force (Model Estimated)
Time frame: Baseline
Ankle Range of Motion
Time frame: Baseline
Peak Ankle Moment
Time frame: Baseline
Peak Ankle Power
Time frame: Baseline
Four Square Step Test (4SST)
Time frame: Baseline
Sit to Stand 5 Times (STS5)
Time frame: Baseline
The Orthotics Prosthetics Users' Survey (OPUS)
Time frame: Baseline
Modified Socket Comfort Score (Comfort)
Time frame: Baseline
Modified Socket Comfort Score (Smoothness)
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
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 Custom Carbon Fiber Dynamic Orthosis (CDO) in people with Ankle Fractures and Post-traumatic Osteoarthritis, 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 8 inclusion and 31 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 30 Jan 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?
Yes. Results are posted in the registry (first posted 23 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Joint Contact Stress Time Exposure (Model Estimated) (time frame: Baseline). The study lists 16 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 30 Jan 2026.