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New treatment option for Foot Injury
Official title From Opinion to Evidence: Multi-site Evaluation of Custom Dynamic Orthosis Best Practices
ClinicalTrials.gov ID: NCT06352788
What this study is testing
- What it's testing
- This study is designed to support evidence-based practice and optimal care by evaluating how different configurations of two types of carbon fiber custom dynamic orthoses (CDOs) influences outcomes following traumatic lower extremity injury.
- 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
- Between the ages of 18 and 65
- 2 or more years from a traumatic injury below the knee
- Ability to be fit with an orthosis
- Any of the following:
- Weakness of ankle plantarflexors (\<4/5 on manual muscle test)
You likely can't join if
- Pain greater than 8/10 at rest
- Ankle weakness or spasticity as a result of spinal cord injury or central nervous system pathology
- Use of an orthosis including the knee
- Non-ambulatory
- Surgery on study limb anticipated in next 4 months
- Medical or psychological conditions that would influence functional testing (e.g., severe traumatic brain injury, stroke, heart disease, vestibular...
See the full eligibility criteria
- Between the ages of 18 and 65
- 2 or more years from a traumatic injury below the knee
- Ability to be fit with an orthosis
- Any of the following:
- Weakness of ankle plantarflexors (\<4/5 on manual muscle test)
- Limited pain-free ankle motion (dorsiflexion (DF) \<10° or plantarflexion (PF) \<20°)
- Mechanical pain with loading to hindfoot/midfoot (\>=4/10 Numerical pain rating scale)
- Fusion or candidate for fusion of the ankle or hindfoot
- Candidate for amputation secondary to ankle/foot injury and impairment
- Pain greater than 8/10 at rest
- Ankle weakness or spasticity as a result of spinal cord injury or central nervous system pathology
- Use of an orthosis including the knee
- Non-ambulatory
- Surgery on study limb anticipated in next 4 months
- Medical or psychological conditions that would influence functional testing (e.g., severe traumatic brain injury, stroke, heart disease, vestibular disorder)
- Neurologic, musculoskeletal, or other conditions limiting function of the contralateral extremity
- Uncorrected visual or hearing impairments
- Pregnancy
- Non-English speaking
- BMI \> 40
The study team makes the final eligibility decision.
Where it's taking place
- San Diego, California, United States
- Iowa City, Iowa, United States
- Minneapolis, Minnesota, United States
- Rochester, Minnesota, United States
- Nashville, Tennessee, 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 San Diego, California, United States; Iowa City, Iowa, United States; Minneapolis, Minnesota, United States; Rochester, Minnesota, United States; Nashville, Tennessee, 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.