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New treatment option for Lower Extremity Injuries
Official title Effect of Custom Dynamic Orthoses on Forefoot Loading
ClinicalTrials.gov ID: NCT06710119
What this study is testing
- What it's testing
- The proposed study is designed to evaluate how foot loading changes during initial accommodation to a carbon fiber custom dynamic orthosis (CDO), after targeted training with or without visual feedback of foot loading, and after take-home use of the CDO. This study will quantify initial offloading associated with CDO use and determine if visual feedback of foot loading and additional take-home use of the CDO can further reduce forces, as orthotists work to provide CDOs to patients.
- Which group you join is decided by chance.
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
- Patient Ages: 18-65
- Sustained a function limiting injury below the knee, requiring a carbon fiber custom dynamic orthosis
- Shoe size between women's 8 and 13.5 or men's 6.5 and 13
- Any of the following: weakness of ankle plantarflexors (\ 4/10 on verbal numeric pain rating scale), ankle or hindfoot fusion, candidate for ankle or...
- Ability to walk 25 feet without using a cane or crutch
You likely can't join if
- Pain \> 9/10 while walking
- Ankle weakness as a result of spinal cord injury or central nervous system pathology
- AFO or CDO prescription that includes a knee brace or goes up to thigh
- Medical or psychological conditions that would preclude functional testing (ex. severe traumatic brain injury, heart condition, clotting disorder...
- Nerve, muscle, bone, or other condition limiting function of the contralateral extremity
- BMI greater than 40
See the full eligibility criteria
- Patient Ages: 18-65
- Sustained a function limiting injury below the knee, requiring a carbon fiber custom dynamic orthosis
- Shoe size between women's 8 and 13.5 or men's 6.5 and 13
- Any of the following: weakness of ankle plantarflexors (\ 4/10 on verbal numeric pain rating scale), ankle or hindfoot fusion, candidate for ankle or hindfoot fusion, candidate for amputation secondary to ankle/foot...
- Ability to walk 25 feet without using a cane or crutch
- Ability to walk at a slow to moderate pace
- Able to read and write in English and provide written informed consent Patient
- Pain \> 9/10 while walking
- Ankle weakness as a result of spinal cord injury or central nervous system pathology
- AFO or CDO prescription that includes a knee brace or goes up to thigh
- Medical or psychological conditions that would preclude functional testing (ex. severe traumatic brain injury, heart condition, clotting disorder, lung condition, stroke, vestibular disorder)
- Nerve, muscle, bone, or other condition limiting function of the contralateral extremity
- BMI greater than 40
- Visual or hearing impairment that limit walking ability or limit the ability to comply with instructions given during testing
- Pregnancy
The study team makes the final eligibility decision.
Where it's taking place
- Iowa City, Iowa, United States
- Everett, Washington, 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; Everett, Washington, 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.