BridgeMD
New treatment option for Traumatic Lower Limb Injury
Official title The Effects of Heel Distraction Height on Foot Loading With Carbon Fiber Custom Dynamic Orthoses
ClinicalTrials.gov ID: NCT06127316
What this study is testing
- What it's testing
- 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.
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
You may be able to join if
- 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
- Ability to walk without a cane or crutch
You likely can't join if
- 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...
- Ankle weakness resulting from spinal cord injury or central nervous system pathology
- Nerve, muscle, bone, or other condition limiting function in the contralateral extremity
- Rheumatoid or inflammatory arthritis
- Necrosis of any bones in the foot or ankle
See the full eligibility criteria
- 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
- Ability to walk without a cane or crutch
- Ability to read and write in English and provide written informed consent
- 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
- Rheumatoid or inflammatory arthritis
- Necrosis of any bones in the foot or ankle
- Pain of 8/10 or greater during walking
- Uncorrected visual or hearing impairments
- Require use of a knee stabilizing device to perform daily activities (i.e., Knee ankle foot orthosis, knee orthosis, etc.)
- Pregnancy
- Body mass index greater than 40 kg/m2
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. 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.