NCT06352788 From Opinion to Evidence: Multi-site Evaluation of Custom Dynamic Orthosis Best Practices
| NCT ID | NCT06352788 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Jason Wilken |
| Condition | Foot Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 35 participants |
| Start Date | 2024-07-02 |
| Primary Completion | 2027-08-31 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
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.
Eligibility Criteria
Inclusion 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 Exclusion Criteria: * 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