An interventional study of Carbon Fiber Custom Dynamic Orthosis and Carbon Fiber Footplate in Trauma Injury, sponsored by Jason Wilken. Recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-31.
Sponsored by Jason Wilken · Not applicable, Interventional, and Other
Carbon fiber custom dynamic orthoses (CDOs) improve function, reduce pain, and offload the foot and ankle. CDOs include a proximal cuff that wraps around the leg just below the knee, a posterior carbon fiber strut that bends to store and return energy, and a semi-rigid carbon fiber footplate. The purpose of this study is to determine the effect of CDO use and CDO footplate stiffness on foot loading, limb mechanics, pain, and comfort.
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.[1-3] 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. Studies have previously investigated the effects of design characteristics on gait biomechanics and foot loading, however, the effect of foot plate stiffness on resulting foot loading is unknown.
The purpose of this study is to determine the effect of CDO use and CDO footplate stiffness on foot loading, limb mechanics, pain, and comfort. In this study, forces acting under the foot will be measured using wireless Loadsol insoles (Novel GMBH, St. Paul, MN) and limb mechanics will be measured using motion capture cameras and force plates as participants walk without an orthosis (NoCDO), with a CDO, and with a CDO plus added carbon fiber stiffening inserts (1/2) at a controlled walking speed. Participants will be provided a heel lift for the contralateral limb to prevent leg length discrepancies during walking if necessary. After walking in each condition, participants will complete questionnaires concerning pain and orthosis comfort.
51 studies on the registry are indexed under Accidental Injuries; 28 are open to participants now.
This study's planned enrollment of 20 is below the median of 115 across 30 interventional studies indexed under Accidental Injuries.
Browse Accidental Injuries studies →Jason Wilken is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
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Exclusion Criteria
Participants will complete study activities without a CDO
Participants will complete study activities while wearing a CDO with standard footplate stiffness
Device: Carbon Fiber Custom Dynamic Orthosis
Participants will complete study activities while wearing a CDO with standard footplate stiffness and one additional carbon fiber footplate to increase footplate stiffness
Device: Carbon Fiber Custom Dynamic Orthosis · Device: Carbon Fiber Footplate
Participants will complete study activities while wearing a CDO with standard footplate stiffness and two additional carbon fiber footplates to increase footplate stiffness
Device: Carbon Fiber Custom Dynamic Orthosis · Device: Carbon Fiber Footplate
The carbon fiber custom dynamic orthosis (CDO) used in this study will consist of a semi-rigid carbon fiber footplate, a carbon fiber posterior strut, and a proximal cuff that wraps around the leg below the knee.
Also known as: ankle foot orthosis
One or two additional full-length carbon fiber footplates will be placed under the CDO footplate to increase the effective footplate stiffness
Peak Forefoot Force
Plantar forces (N) will be measured across the forefoot (distal 40% of sensor).
Time frame: Baseline
Forefoot Force Impulse
Plantar force impulse (Ns) across the forefoot (distal 40% of sensor) will be calculated using the integral of the force over the stance phase.
Time frame: Baseline
Peak Hindfoot Force
Plantar forces (N) will be measured across the hindfoot (proximal 30% sensor).
Time frame: Baseline
Hindfoot Force Impulse
Plantar force impulse (Ns) across the hindfoot (proximal 30% sensor) will be calculated using the integral of the force over the stance phase.
Time frame: Baseline
Peak Ankle Power
Peak sagittal plane ankle push-off power (W/kg) during gait.
Time frame: Baseline
Peak Midfoot Force
Plantar forces (N) will be measured across the midfoot (middle 30% of sensor).
Time frame: Baseline
Midfoot Force Impulse
Plantar force impulse (Ns) across the midfoot (middle 30% of sensor) will be calculated using the integral of the force over the stance phase.
Time frame: Baseline
Peak Total Foot Force
Plantar forces (N) will be measured across the total foot (100% of sensors).
Time frame: Baseline
Total Foot Force Impulse
Plantar force impulse (Ns) across the total foot (100% of sensors) will be calculated using the integral of the force over the stance phase.
Time frame: Baseline
Peak Ankle Dorsiflexion
Peak ankle dorsiflexion (degrees) during gait.
Time frame: Baseline
Peak Ankle Plantarflexion
Peak ankle plantarflexion (degrees) during gait.
Time frame: Baseline
Ankle Range of Motion
Range of ankle motion (degrees) during gait.
Time frame: Baseline
Peak Ankle Dorsiflexion Moment
Peak ankle dorsiflexion moment (Nm/kg) during gait.
Time frame: Baseline
Peak Ankle Plantarflexion Moment
Peak ankle plantarflexion moment (Nm/kg) during gait.
Time frame: 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
Time frame: Baseline
Modified Socket Comfort Score (Comfort)
Comfort scores range from 0 = most uncomfortable to 10= most comfortable
Time frame: Baseline
Modified Socket Comfort Score (Smoothness)
Smoothness scores range from 0 = least smooth to 10 = most smooth
Time frame: Baseline
Plan to share: No
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