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.
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
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
Crossover
Carbon Fiber Custom Dynamic Orthosis (CDO)
DeviceThe 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.
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.
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.
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.
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.
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.
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.
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.
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.
Semi-Structured Interview
Participants will be asked a number of open ended questions to help determine what factors influenced their perception of each study condition.
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University of Iowa
Lead sponsor
Fabtech Systems
Collaborator
