An interventional study of Modular Carbon Fiber Custom Dynamic Orthosis (CDO) and Mono Carbon Fiber Custom Dynamic Orthosis (CDO) in Foot Injury, sponsored by Jason Wilken. Recruiting at 5 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-01-15.
Sponsored by Jason Wilken · Not applicable, Interventional, and Treatment
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.
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.
51 studies on the registry are indexed under Foot Injuries; 10 are open to participants now.
This study's planned enrollment of 35 is below the median of 52 across 38 interventional studies indexed under Foot Injuries.
Browse Foot Injuries studies →Jason Wilken is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Participants will first be evaluated without a CDO (NoCDO), then in CDO configuration A, CDO configuration B, and finally CDO configuration C.
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.
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.
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.
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.
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.
Device: Modular Carbon Fiber Custom Dynamic Orthosis (CDO) · Device: Mono Carbon Fiber Custom Dynamic Orthosis (CDO)
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.
Also known as: Reaktiv (Fabtech Systems LLC, Everett WA)
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.
Also known as: Posterior Spring (Bio-Mechanical Composites, Inc., Des Moines, IA)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline
Ankle Range of Motion (degrees)
Participants completed a biomechanical gait analysis session. Sagittal plane ankle range of motion (degrees) was measured throughout the gait cycle. Smaller range of motion is expected with each CDO.
Time frame: Baseline
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