Foot InjuryAFOSVANCT06352788
From Opinion to Evidence: Multi-site Evaluation of Custom Dynamic Orthosis Best Practices
A study testing Modular Carbon Fiber Custom Dynamic Orthosis (CDO) and Mono Carbon Fiber Custom Dynamic Orthosis (CDO) in people with Foot Injury, run by Jason Wilken at 5 sites in United States.
Trial summary
This study is designed to support evidence-based practice and optimal care by evaluating how different configurations of two types of carbon fiber custom dynamic orthoses (CDOs) influences outcomes following traumatic lower extremity injury. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Foot Injury
- What is being tested?
- Modular Carbon Fiber Custom Dynamic Orthosis (CDO) and Mono 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
- 35 participants
- Where
- 5 sitesUnited States
- Study dates
- 2 Jul 2024to 1 Sep 2028
- 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
- Between the ages of 18 and 65
- 2 or more years from a traumatic injury below the knee
- Ability to be fit with an orthosis
- Any of the following:
- Weakness of ankle plantarflexors (<4/5 on manual muscle test)
- Limited pain-free ankle motion (dorsiflexion (DF) <10° or plantarflexion (PF) <20°)
Show all 9Show fewer
- Mechanical pain with loading to hindfoot/midfoot (>=4/10 Numerical pain rating scale)
- Fusion or candidate for fusion of the ankle or hindfoot
- Candidate for amputation secondary to ankle/foot injury and impairment
Who cannot join
- Pain greater than 8/10 at rest
- Ankle weakness or spasticity as a result of spinal cord injury or central nervous system pathology
- Use of an orthosis including the knee
- Non-ambulatory
- Surgery on study limb anticipated in next 4 months
- Medical or psychological conditions that would influence functional testing (e.g., severe traumatic brain injury, stroke, heart disease, vestibular disorder)
Show all 11Show fewer
- Neurologic, musculoskeletal, or other conditions limiting function of the contralateral extremity
- Uncorrected visual or hearing impairments
- Pregnancy
- Non-English speaking
- BMI > 40
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
University of Iowa
Iowa City, Iowa, 52242
Jason M Wilken, PT, PhD, 319-335-6857, jason-wilken@uiowa.edu
Molly S Pacha, MS, ATC, LAT, 319-290-7596, molly-pacha@uiowa.edu
- Recruiting
Minneapolis VA Health Care System - Motion Analysis Laboratory
Minneapolis, Minnesota, 55417
John Looft, PhD, john.looft@va.gov
- Recruiting
Vanderbilt University - Zelik Lab For Biomechanics & Assistive Technology
Nashville, Tennessee, 37212
Karl Zelik, PhD, karl.zelik@vanderbilt.edu
- Recruiting
Mayo Clinic - Motion Analysis Lab
Rochester, Minnesota, 55905
Kenton R Kaufman, PhD, Kaufman.Kenton@mayo.edu
- Recruiting
Naval Medical Center San Diego - Clinical Biomechanics Laboratory
San Diego, California, 92134
Trevor Kingsbury, PhD, trevor.d.kingsbury.civ@health.mil
About this study
This study is designed to support evidence-based practice and optimal care by evaluating how different configurations of two types of carbon fiber custom dynamic orthoses (CDOs) influences outcomes following traumatic lower extremity injury.
Read the detailed description
This study is designed to evaluate how different configurations of two types of carbon fiber custom dynamic orthoses (CDOs) influence outcomes following traumatic lower extremity injury. In this study, adult participants who still experiencing deficits including weakness and/or immobility more than two years post traumatic lower extremity injury will be randomized and fit with either modular or monolithic CDO.
Participants will then be evaluated without a CDO and with the CDO in three configurations in a randomized order: a proposed optimal benchmark configuration, a variation with the device in more dorsiflexion, and a variation with the device in greater plantarflexion. Multiple well-established tests will be used to compare outcomes between the different configurations.
- Conditions
- Foot Injury
- Being tested
- Modular Carbon Fiber Custom Dynamic Orthosis (CDO), Mono Carbon Fiber Custom Dynamic Orthosis (CDO)
- Keywords
- Ankle Foot Orthosis, Carbon Fiber, Gait, Biomechanics, Physical Performance
- Medical subject headings
- Foot Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modular Carbon Fiber Custom Dynamic Orthosis (CDO)Device
Also called Reaktiv (Fabtech Systems LLC, Everett WA)
The CDO will use a modular design that includes a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee.
Mono Carbon Fiber Custom Dynamic Orthosis (CDO)Device
Also called Posterior Spring (Bio-Mechanical Composites, Inc., Des Moines, IA)
The CDO will use a mono design that includes a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee.
| Study group | Role | What they receive |
|---|---|---|
| NoCDO, A, B, C | Experimental | Participants will first be evaluated without a CDO (NoCDO), then in CDO configuration A, CDO configuration B, and finally CDO configuration C. Receives: Device: Modular Carbon Fiber Custom Dynamic Orthosis (CDO); Device: Mono Carbon Fiber Custom Dynamic Orthosis (CDO) |
| NoCDO, A, C, B | Experimental | Participants will first be evaluated without a CDO (NoCDO), then in CDO configuration A, CDO configuration C, and finally CDO configuration B. Receives: Device: Modular Carbon Fiber Custom Dynamic Orthosis (CDO); Device: Mono Carbon Fiber Custom Dynamic Orthosis (CDO) |
| NoCDO, B, A, C | Experimental | Participants will first be evaluated without a CDO (NoCDO), then in CDO configuration B, CDO configuration A, and finally CDO configuration C. Receives: Device: Modular Carbon Fiber Custom Dynamic Orthosis (CDO); Device: Mono Carbon Fiber Custom Dynamic Orthosis (CDO) |
| NoCDO, B, C, A | Experimental | Participants will first be evaluated without a CDO (NoCDO), then in CDO configuration B, CDO configuration C, and finally CDO configuration A. Receives: Device: Modular Carbon Fiber Custom Dynamic Orthosis (CDO); Device: Mono Carbon Fiber Custom Dynamic Orthosis (CDO) |
| NoCDO, C, A, B | Experimental | Participants will first be evaluated without a CDO (NoCDO), then in CDO configuration C, CDO configuration A, and finally CDO configuration B. Receives: Device: Modular Carbon Fiber Custom Dynamic Orthosis (CDO); Device: Mono Carbon Fiber Custom Dynamic Orthosis (CDO) |
| NoCDO, C, B, A | Experimental | Participants will first be evaluated without a CDO (NoCDO), then in CDO configuration C, CDO configuration B, and finally CDO configuration A. Receives: Device: Modular Carbon Fiber Custom Dynamic Orthosis (CDO); Device: Mono Carbon Fiber Custom Dynamic Orthosis (CDO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PROMIS Physical Function
The Patient Reported Outcome Information System (PROMIS) Physical Function Computer Adaptive Test (CAT) is a computerized assessment measuring physical function. It is scored using a T-score in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. In a given PROMIS domain, a T-score above 50 represents greater physical function than the population average. Larger scores are better.
Measured: Baseline
PROMIS Pain Interference
The Patient Reported Outcome Information System (PROMIS) Pain Interference Computer Adaptive Test (CAT) is a computerized assessment measuring pain interference. It is scored using a T-score in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. In a given PROMIS domain, a T-score above 50 represents greater pain interference than the population average. Lower scores are better.
Measured: Baseline
OPUS Satisfaction with Device and Services
Satisfaction with device and services will be assessed using the Orthotics Prosthetics Users' Survey Satisfaction With Device and Services Score (11-55). Lower scores indicate a better outcome and more satisfaction with the CDO and accompanying services.
Measured: Baseline
Modified Socket Comfort Score - Comfort
Participants were asked to rate the comfort of each CDO configuration on a scale from 0-10 with 0 = most uncomfortable to 10 = most comfortable. Higher scores indicate more comfortable conditions, and are considered better.
Measured: Baseline
Modified Socket Comfort Score - Smoothness
Participants were asked to rate the smoothness of each CDO configuration on a scale from 0-10 with 0 = most smooth to 10 = least smooth. Lower scores indicate smoother conditions, and are considered better.
Measured: Baseline
Numerical Pain Rating Scale
Pain will be assessed using a standard 11-point numerical pain rating scale (NPRS), in which 0 = no pain and 10 = worst pain imaginable. Lower scores are considered better.
Measured: Baseline
Preference - Ranked
The participant will be asked to rank order the conditions they have completed testing for at each visit: at the 3rd visit they will rank order their preference for using no orthosis or using the CDO in the first configuration, at the 4th visit they will rank order their preference for using no orthosis, using the CDO in the first configuration, and using the CDO in the second configuration, at the 5th visit they will rank order their preference for using no orthosis, using the CDO in the first configuration, using the CDO in the second configuration, and using the CDO in the third configuration.
Measured: Baseline
Preference - CDO Configuration
For each CDO configuration, participants will be asked to rank their preference on a scale from 0 (least preferred) to 10 (most preferred) for a number of questions concerning CDO use. Higher scores indicate higher preferences and are considered better.
Measured: Baseline
Four Square Step Test (seconds)
The 4SST (seconds) is a standardized timed test of balance and agility. Participants start in the lower left quadrant of a Maltese cross setting on the floor and are timed as they move counterclockwise (forward, right, backward, left) and then clockwise (right, forward, left, backward) around the cross. Participants are instructed to move as quickly as they safely can. Lower times indicate faster completion of the test and are considered better results.
Measured: Baseline
Sit to Stand 5 Times (seconds)
STS5 (seconds) is a well-established timed measure of lower limb muscle strength and power. Participants are instructed to stand up and sit down 5 times as fast as possible. Lower scores indicate a faster time to complete the test and are considered better results.
Measured: Baseline
Center of Pressure Velocity Magnitude (m/s)
The center of pressure (CoP) is the centroid of the forces acting on the foot during gait. The magnitude of the peak center of pressure velocity (m/s) is the fastest the CoP moves during gait.
Measured: Baseline
Center of Pressure Velocity Timing (%stance)
The center of pressure (CoP) is the centroid of the forces acting on the foot during gait. The timing of the peak center of pressure velocity, is the percent of the stance phase (%stance) where the CoP is moving fastest during gait.
Measured: Baseline
Ankle Zero Moment Crossing (%stance)
The ankle zero moment crossing is the point during the stance phase of gait (%stance) where the ankle moment transitions from a dorsiflexion to a plantarflexion moment.
Measured: Baseline
Peak Ankle Dorsiflexion (degree)
Participants completed a biomechanical gait analysis session. Sagittal plane peak ankle joint dorsiflexion angle (degree) that occurs late in the stance phase of gait.
Measured: Baseline
Peak Ankle Plantarflexion Moment (Nm/kg)
Participants completed a biomechanical gait analysis session. Sagittal plane peak ankle joint plantarflexion moment normalized to participant body weight (Nm/kg) that occurs late in the stance phase of gait.
Measured: Baseline
Peak Ankle Push-Off Power (W/kg)
Participants completed a biomechanical gait analysis session. Sagittal plane peak ankle joint power normalized to body weight (W/kg) occurs late in the stance phase of gait.
Measured: Baseline
Secondary outcomes (3)
PROMIS Satisfaction with Participation in Social Activities
The Patient Reported Outcome Information System (PROMIS) satisfaction with participation in social activities Computer Adaptive Test (CAT) is a computerized assessment measuring satisfaction with participation in social activities. It is scored using a T-score in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. In a given PROMIS domain, a T-score above 50 represents greater participation in social activities than the population average, larger scores are considered better.
Measured: Baseline
PROMIS Satisfaction with Participation in Discretionary Social Activities
The Patient Reported Outcome Information System (PROMIS) satisfaction with participation in social activities Computer Adaptive Test (CAT) is a computerized assessment measuring satisfaction with participation in social activities. It is scored using a T-score in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. In a given PROMIS domain, a T-score above 50 represents greater participation in discretionary social activities than the population average, larger scores are considered better.
Measured: Baseline
PROMIS Depression
The Patient Reported Outcome Information System (PROMIS) depression Computer Adaptive Test (CAT) is a computerized assessment measuring depression. It is scored using a T-score in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. In a given PROMIS domain, a T-score above 50 represents greater levels of depression than the population average, lower scores are considered better.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start2 Jul 2024
- Primary completion31 Aug 2027 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foot 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will be cast and fit with either a carbon fiber custom dynamic orthosis (CDO) with a modular or mono design. After being fit with the CDO they will complete testing with the CDO in three different configurations (A, B, C) in a randomized order and without the CDO.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jason Wilken
- Sponsor type
- University, hospital or other
- Collaborators
- Mayo Clinic, Vanderbilt University Medical Center, Navy Medical Center San Diego, Minneapolis Veterans Affairs Medical Center, Johns Hopkins University
- Responsible party
- Sponsor-investigator, Jason Wilken, University of Iowa
- Investigators
- Jason M Wilken, PT, PhD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06352788
- Sponsor's protocol ID
- 202007224
- Other IDs
- CDMRP-OP210038
- Acronym
- AFOSVA
- Status last verified
- Oct 2026
- First submitted
- 2 Apr 2024
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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
- From Opinion to Evidence: Multi-site Evaluation of Custom Dynamic Orthosis Best Practices
- ClinicalTrials.gov ID
- NCT06352788
- Acronym / sponsor ID
- AFOSVA / 202007224
- Conditions
- Foot Injury
- Keywords
- Ankle Foot Orthosis, Carbon Fiber, Gait, Biomechanics, Physical Performance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Jason WilkenUniversity, hospital or other
- Collaborators
- Mayo Clinic, Vanderbilt University Medical Center, Navy Medical Center San Diego, Minneapolis Veterans Affairs Medical Center, Johns Hopkins University
- Study start
- 2 Jul 2024 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 8 Apr 2024 (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.
This study is designed to support evidence-based practice and optimal care by evaluating how different configurations of two types of carbon fiber custom dynamic orthoses (CDOs) influences outcomes following traumatic lower extremity injury.
Detailed description
This study is designed to evaluate how different configurations of two types of carbon fiber custom dynamic orthoses (CDOs) influence outcomes following traumatic lower extremity injury. In this study, adult participants who still experiencing deficits including weakness and/or immobility more than two years post traumatic lower extremity injury will be randomized and fit with either modular or monolithic CDO.
Participants will then be evaluated without a CDO and with the CDO in three configurations in a randomized order: a proposed optimal benchmark configuration, a variation with the device in more dorsiflexion, and a variation with the device in greater plantarflexion. Multiple well-established tests will be used to compare outcomes between the different configurations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- Participants will be cast and fit with either a carbon fiber custom dynamic orthosis (CDO) with a modular or mono design. After being fit with the CDO they will complete testing with the CDO in three different configurations (A, B, C) in a randomized order and without the CDO.
| Arm | Type | Receives |
|---|---|---|
| NoCDO, A, B, C | Experimental | Device: Modular Carbon Fiber Custom Dynamic Orthosis (CDO), Device: Mono Carbon Fiber Custom Dynamic Orthosis (CDO)Participants will first be evaluated without a CDO (NoCDO), then in CDO configuration A, CDO configuration B, and finally CDO configuration C. |
| NoCDO, A, C, B | Experimental | Device: Modular Carbon Fiber Custom Dynamic Orthosis (CDO), Device: Mono Carbon Fiber Custom Dynamic Orthosis (CDO)Participants will first be evaluated without a CDO (NoCDO), then in CDO configuration A, CDO configuration C, and finally CDO configuration B. |
| NoCDO, B, A, C | Experimental | Device: Modular Carbon Fiber Custom Dynamic Orthosis (CDO), Device: Mono Carbon Fiber Custom Dynamic Orthosis (CDO)Participants will first be evaluated without a CDO (NoCDO), then in CDO configuration B, CDO configuration A, and finally CDO configuration C. |
| NoCDO, B, C, A | Experimental | Device: Modular Carbon Fiber Custom Dynamic Orthosis (CDO), Device: Mono Carbon Fiber Custom Dynamic Orthosis (CDO)Participants will first be evaluated without a CDO (NoCDO), then in CDO configuration B, CDO configuration C, and finally CDO configuration A. |
| NoCDO, C, A, B | Experimental | Device: Modular Carbon Fiber Custom Dynamic Orthosis (CDO), Device: Mono Carbon Fiber Custom Dynamic Orthosis (CDO)Participants will first be evaluated without a CDO (NoCDO), then in CDO configuration C, CDO configuration A, and finally CDO configuration B. |
| NoCDO, C, B, A | Experimental | Device: Modular Carbon Fiber Custom Dynamic Orthosis (CDO), Device: Mono Carbon Fiber Custom Dynamic Orthosis (CDO)Participants will first be evaluated without a CDO (NoCDO), then in CDO configuration C, CDO configuration B, and finally CDO configuration A. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Between the ages of 18 and 65
- 2 or more years from a traumatic injury below the knee
- Ability to be fit with an orthosis
- Any of the following:
Key exclusion criteria (11 listed)
- Pain greater than 8/10 at rest
- Ankle weakness or spasticity as a result of spinal cord injury or central nervous system pathology
- Use of an orthosis including the knee
- Non-ambulatory
- Surgery on study limb anticipated in next 4 months
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 |
|---|---|---|
| Modular Carbon Fiber Custom Dynamic Orthosis (CDO)Also: Reaktiv (Fabtech Systems LLC, Everett WA)The CDO will use a modular design that includes a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. | Device | NoCDO, A, B, C, NoCDO, A, C, B, NoCDO, B, A, C, NoCDO, B, C, A, NoCDO, C, A, B, NoCDO, C, B, A |
| Mono Carbon Fiber Custom Dynamic Orthosis (CDO)Also: Posterior Spring (Bio-Mechanical Composites, Inc., Des Moines, IA)The CDO will use a mono design that includes a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. | Device | NoCDO, A, B, C, NoCDO, A, C, B, NoCDO, B, A, C, NoCDO, B, C, A, NoCDO, C, A, B, NoCDO, C, B, A |
Primary outcome
PROMIS Physical Function
Time frame: Baseline
The Patient Reported Outcome Information System (PROMIS) Physical Function Computer Adaptive Test (CAT) is a computerized assessment measuring physical function. It is scored using a T-score in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. In a given PROMIS domain, a T-score above 50 represents greater physical function than the population average. Larger scores are better.
PROMIS Pain Interference
Time frame: Baseline
The Patient Reported Outcome Information System (PROMIS) Pain Interference Computer Adaptive Test (CAT) is a computerized assessment measuring pain interference. It is scored using a T-score in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. In a given PROMIS domain, a T-score above 50 represents greater pain interference than the population average. Lower scores are better.
OPUS Satisfaction with Device and Services
Time frame: Baseline
Satisfaction with device and services will be assessed using the Orthotics Prosthetics Users' Survey Satisfaction With Device and Services Score (11-55). Lower scores indicate a better outcome and more satisfaction with the CDO and accompanying services.
Modified Socket Comfort Score - Comfort
Time frame: Baseline
Participants were asked to rate the comfort of each CDO configuration on a scale from 0-10 with 0 = most uncomfortable to 10 = most comfortable. Higher scores indicate more comfortable conditions, and are considered better.
Modified Socket Comfort Score - Smoothness
Time frame: Baseline
Participants were asked to rate the smoothness of each CDO configuration on a scale from 0-10 with 0 = most smooth to 10 = least smooth. Lower scores indicate smoother conditions, and are considered better.
Numerical Pain Rating Scale
Time frame: Baseline
Pain will be assessed using a standard 11-point numerical pain rating scale (NPRS), in which 0 = no pain and 10 = worst pain imaginable. Lower scores are considered better.
Preference - Ranked
Time frame: Baseline
The participant will be asked to rank order the conditions they have completed testing for at each visit: at the 3rd visit they will rank order their preference for using no orthosis or using the CDO in the first configuration, at the 4th visit they will rank order their preference for using no orthosis, using the CDO in the first configuration, and using the CDO in the second configuration, at the 5th visit they will rank order their preference for using no orthosis, using the CDO in the first configuration, using the CDO in the second configuration, and using the CDO in the third configuration.
Preference - CDO Configuration
Time frame: Baseline
For each CDO configuration, participants will be asked to rank their preference on a scale from 0 (least preferred) to 10 (most preferred) for a number of questions concerning CDO use. Higher scores indicate higher preferences and are considered better.
Four Square Step Test (seconds)
Time frame: Baseline
The 4SST (seconds) is a standardized timed test of balance and agility. Participants start in the lower left quadrant of a Maltese cross setting on the floor and are timed as they move counterclockwise (forward, right, backward, left) and then clockwise (right, forward, left, backward) around the cross. Participants are instructed to move as quickly as they safely can. Lower times indicate faster completion of the test and are considered better results.
Sit to Stand 5 Times (seconds)
Time frame: Baseline
STS5 (seconds) is a well-established timed measure of lower limb muscle strength and power. Participants are instructed to stand up and sit down 5 times as fast as possible. Lower scores indicate a faster time to complete the test and are considered better results.
Center of Pressure Velocity Magnitude (m/s)
Time frame: Baseline
The center of pressure (CoP) is the centroid of the forces acting on the foot during gait. The magnitude of the peak center of pressure velocity (m/s) is the fastest the CoP moves during gait.
Center of Pressure Velocity Timing (%stance)
Time frame: Baseline
The center of pressure (CoP) is the centroid of the forces acting on the foot during gait. The timing of the peak center of pressure velocity, is the percent of the stance phase (%stance) where the CoP is moving fastest during gait.
Ankle Zero Moment Crossing (%stance)
Time frame: Baseline
The ankle zero moment crossing is the point during the stance phase of gait (%stance) where the ankle moment transitions from a dorsiflexion to a plantarflexion moment.
Peak Ankle Dorsiflexion (degree)
Time frame: Baseline
Participants completed a biomechanical gait analysis session. Sagittal plane peak ankle joint dorsiflexion angle (degree) that occurs late in the stance phase of gait.
Peak Ankle Plantarflexion Moment (Nm/kg)
Time frame: Baseline
Participants completed a biomechanical gait analysis session. Sagittal plane peak ankle joint plantarflexion moment normalized to participant body weight (Nm/kg) that occurs late in the stance phase of gait.
Peak Ankle Push-Off Power (W/kg)
Time frame: Baseline
Participants completed a biomechanical gait analysis session. Sagittal plane peak ankle joint power normalized to body weight (W/kg) occurs late in the stance phase of gait.
3 secondary outcomes
PROMIS Satisfaction with Participation in Social Activities
Time frame: Baseline
PROMIS Satisfaction with Participation in Discretionary Social Activities
Time frame: Baseline
PROMIS Depression
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
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modular Carbon Fiber Custom Dynamic Orthosis (CDO) and Mono Carbon Fiber Custom Dynamic Orthosis (CDO) in people with Foot Injury, run by Jason Wilken at 5 sites 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 9 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 5 sites 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?
PROMIS Physical Function (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 21 Oct 2026.