From Opinion to Evidence: Multi-site Evaluation of Custom Dynamic Orthosis Best Practices
Jason Wilken
35 participants
Jul 2, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria9
- Between the ages of 18 and 65
- 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 Criteria11
- 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
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Interventions
The CDO will use a modular design that includes a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee.
The CDO will use a mono design that includes a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee.
Locations(5)
View Full Details on ClinicalTrials.gov
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NCT06352788