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New treatment option for Trauma Injury
Official title The Effects of Footplate Stiffness on Foot Loading Within Carbon Fiber Custom Dynamic Orthoses
ClinicalTrials.gov ID: NCT07312032
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- Between the ages of 18 and 65
- Healthy without current complaint of lower extremity pain, spine pain, open wounds or active infections, or medical or neuromusculoskeletal disorders...
- Able to hop without pain
- Able to perform a full squat without pain
- Ability to read and write in English and provide written informed consent
You likely can't join if
- Diagnosed with a moderate or severe brain injury
- Lower extremity injury resulting in surgery or limiting function for greater than 6 weeks
- Injuries that would limit performance in this study
- Diagnosed with a physical or psychological condition that would preclude functional testing (e.g. cardiac condition, clotting disorder, pulmonary...
- Visual or hearing impairments that limit walking ability or limit the ability to comply with instructions given during testing
- Require use of an assistive device
See the full eligibility criteria
- Between the ages of 18 and 65
- Healthy without current complaint of lower extremity pain, spine pain, open wounds or active infections, or medical or neuromusculoskeletal disorders that have limited their participation in work or exercise in the last...
- Able to hop without pain
- Able to perform a full squat without pain
- Ability to read and write in English and provide written informed consent
- Ability to fit in a generic sized CDO
- Diagnosed with a moderate or severe brain injury
- Lower extremity injury resulting in surgery or limiting function for greater than 6 weeks
- Injuries that would limit performance in this study
- Diagnosed with a physical or psychological condition that would preclude functional testing (e.g. cardiac condition, clotting disorder, pulmonary condition)
- Visual or hearing impairments that limit walking ability or limit the ability to comply with instructions given during testing
- Require use of an assistive device
- Unhealed wounds (cuts/abrasions) that would prevent AFO use
- BMI \> 40
- Pregnancy
The study team makes the final eligibility decision.
Where it's taking place
- Iowa City, Iowa, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Iowa City, Iowa, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.