Peak Plantar Pressures While Wearing a Carbon Fiber Off Loading Orthoses (CFO)
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|ClinicalTrials.gov Identifier: NCT03618628|
Recruitment Status : Completed
First Posted : August 7, 2018
Results First Posted : May 13, 2019
Last Update Posted : May 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus Peripheral Neuropathy Orthotic Device||Device: Carbon Fiber Off Loading Orthosis (CFO)||Not Applicable|
The long term goal of this research is the successful incorporation of carbon fiber into an off loading device will provide protection to the insensate foot of people with diabetes by reducing localized peak pressures, and thus the risk of recurrence neuropathic foot wounds and fractures, while improving ankle power at push off that will allow individuals with loss of ankle muscle function to walk faster and return to dynamic activities required in their jobs and for full function in the community. The overall goal of this proposal is to determine effects of carbon fiber off loading orthoses (CFO) design characteristics (lay up and geometry of strut) on brace strength, weight, power return capacity, plantar off-loading and participant comfort using FE models, ex-vivo testing and human testing.
First, a CFO will be fabricated using geometry consistent with the current clinical standard. This representative CFO will serve as a baseline from which a finite element (FE) model will be built. The model will be altered as desired to determine the effects of variable design characteristics. The FE model will estimate brace deflection and stress when the CFO is designed with various lay up designs and brace thicknesses. We will use results from the FE model to fabricate a new CFO for study participants.
We will then measure peak plantar pressures during walking while the participants are barefoot, wearing the CFO consistent with current clinical standards, and wearing the new CFO fabricated based on the results of the FE model. We will also measure plantarflexor power during walking while the participants are wearing the CFO consistent with current clinical standards and while wearing the CFO designed based on the results of the FE model. It is believed that the FE model driven CFO design will lead to improved brace strength while reducing plantar pressure compared to barefoot and will have similar plantarflexor power as the CFO based on current clinical standards.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Carbon Fiber Off-Loading Orthosis|
|Actual Study Start Date :||May 24, 2016|
|Actual Primary Completion Date :||April 12, 2018|
|Actual Study Completion Date :||April 12, 2018|
Experimental: People using a CFO
People who are currently wearing a carbon fiber off loading orthosis (CFO) will have a new CFO fabricated for them based on the results of our finite element (FE) model. We will then test both CFOs ability to reduce peak plantar compared to barefoot and the peak plantarflexor power of both braces.
Device: Carbon Fiber Off Loading Orthosis (CFO)
A finite element (FE) model will be created to determine properties that will improve CFO strength while maintaining reduction of peak plantar pressures of the CFO and plantarflexor power. A new CFO will then be fabricated for the participant. Participants will be tested in while walking barefoot, wearing their current CFO, and wearing the FE model driven CFO.
- Peak Plantar Pressure [ Time Frame: Participant was tested in new brace (based on FE model) after wearing for 1 week. ]Plantar pressure during walking while the participant wears the brace fabricated based on the finite element (FE) model compared to 1) the brace fabricated based on current clinical standards and 2) barefoot.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03618628
|United States, Missouri|
|Saint Louis, Missouri, United States, 63108|
|Principal Investigator:||Mary Hastings, DPT||Washington University School of Medicine|