Carbon Fiber Orthosis for Injury
(CDOCFPlate Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how a special leg brace, the Carbon Fiber Custom Dynamic Orthosis (CDO), affects foot and leg movement, pain, and comfort. The study tests different CDO versions to determine if altering the footplate's stiffness makes a difference. Participants will either wear a CDO with varying stiffness or not wear one at all. This trial suits healthy individuals who can hop and squat without pain and have not experienced a lower body injury or surgery affecting their activities in the last six months. As an unphased trial, it offers participants the chance to contribute to innovative research on enhancing mobility and comfort.
Do I need to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It seems focused on physical criteria, so it's best to ask the trial organizers for clarification.
What prior data suggests that this carbon fiber orthosis is safe for use?
Research has shown that carbon fiber custom dynamic orthoses (CDOs) are generally safe and well-tolerated. In one study, most patients (92%) reported improved physical function after using CDOs. Additionally, 69% of patients experienced less severe pain, and 55% felt a reduction in their usual pain levels. These results suggest that CDOs are effective and comfortable for most people.
Regarding the carbon fiber footplates in these orthoses, studies indicate no increased risk of injuries, such as shin bone stress fractures, when using carbon fiber technology. This means the footplates, essential parts of the CDOs, are considered safe to use.
Overall, both the CDOs and the carbon fiber footplates have proven safe for people, with most users experiencing benefits without negative effects.12345Why are researchers excited about this trial?
Researchers are excited about the Carbon Fiber Custom Dynamic Orthosis (CDO) because it offers a customizable approach to improving mobility for people with injuries. Unlike traditional orthotic devices that often have fixed stiffness, the CDO allows for the adjustment of footplate stiffness with additional carbon fiber footplates. This flexibility means that the device can be tailored to meet the specific needs of each user, potentially enhancing comfort and effectiveness. By exploring different levels of stiffness, researchers hope to find out how these variations impact movement and recovery, which could lead to more personalized treatment options in the future.
What evidence suggests that this trial's treatments could be effective for improving function and reducing pain?
Research has shown that custom-made carbon fiber braces, known as carbon fiber custom dynamic orthoses (CDOs), can help people walk faster and move more easily. One study found that 92% of participants walked faster, and more than half felt they could move more easily. These braces also reduce pain by relieving pressure on the front part of the foot during walking. In this trial, participants may receive a CDO with varying footplate stiffness. Additionally, a carbon fiber footplate can lessen pain and improve overall foot function. These devices store and release energy during movement, enhancing limb function and comfort.16789
Are You a Good Fit for This Trial?
This trial is for individuals aged 18-65 who are healthy, without lower extremity or spine pain, open wounds, infections, or disorders that limited work/exercise in the last 6 months. Participants must be able to hop and squat without pain, read/write in English, consent to the study, and fit a generic CDO.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants undergo baseline assessments including measurement of plantar forces and limb mechanics without any orthosis
Treatment
Participants complete study activities with different CDO configurations to assess the effect of footplate stiffness on foot loading and comfort
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Carbon Fiber Custom Dynamic Orthosis
- Carbon Fiber Footplate
Trial Overview
The study tests how different stiffness levels of footplates in Carbon Fiber Custom Dynamic Orthoses (CDOs) affect foot loading, limb mechanics, pain relief and comfort for those with accidental injuries or peroneal nerve injury.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Active Control
Participants will complete study activities while wearing a CDO with standard footplate stiffness
Participants will complete study activities while wearing a CDO with standard footplate stiffness and two additional carbon fiber footplates to increase footplate stiffness
Participants will complete study activities while wearing a CDO with standard footplate stiffness and one additional carbon fiber footplate to increase footplate stiffness
Participants will complete study activities without a CDO
Find a Clinic Near You
Who Is Running the Clinical Trial?
Jason Wilken
Lead Sponsor
University of Iowa
Collaborator
Citations
The effect of carbon fiber custom dynamic orthosis use and ...
Carbon-fiber custom dynamic orthoses are used to improve gait and limb function following lower limb trauma in specialty centers.
Short-term effect of a carbon fiber custom dynamic orthosis ...
(55%) and experienced improved or greatly improved walking speed (92%) and agility (52%) irrespective of age and sex. Regression.
Foot offloading associated with carbon fiber orthosis use
Compared to walking without an orthosis, peak forefoot forces decreased with carbon fiber custom dynamic orthosis use. · All carbon fiber orthoses significantly ...
Multisite Evaluation of a Custom Energy-Storing Carbon ...
The Intrepid Dynamic Exoskeletal Orthosis (IDEO) is a custom energy-storing carbon fiber ankle-foot orthosis developed for lower-extremity trauma patients.
Short-term effect of a carbon fiber custom dynamic orthosis ...
The use of a carbon fiber custom dynamic orthosis (CDO) with integrated physical training and psychosocial intervention has been shown to improve outcomes in a ...
W81XWH-22-1-0464 TITLE: Carbon Fiber Orthosis Cuff ... - DTIC
The purpose of this study is to determine the effects of CDO proximal cuff design on patient reported outcomes, limb mechanics and loading, and ...
Use of an Integrated Orthotic and Rehabilitation Initiative ...
With this study we are seeking to determine how participation in CUSTOMIZED EXOSKELETAL ORTHOSIS RTP clinical pathway affects patient outcomes as determined by ...
Short-term effect of a carbon fiber custom dynamic orthosis ...
Results A majority of patients reported improved or greatly improved physical function (92%), maximum pain (69%), and typical pain (55%) and experienced ...
Custom Orthoses for Leg Injuries
Studies have shown that custom braces made from carbon fiber, known as dynamic orthoses (CDOs), can enhance walking and leg function after lower leg injuries.
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