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NCT04623853
Investigating Auto Adjusting Dynamic AFO
Conditions: Lower Limb; Fusion, Congenital, Lower Limb Fracture, Ankle Foot Injury
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 22
Sponsor: University of Washington
Location: University of Washington, Dept. of Bioengineering Seattle Washington
Summary
Offloading Ankle Foot Orthoses (AFOs) are devices designed for people following lower-limb reconstruction to restore mobility by reducing mechanical loading through the injury site and redistributing it proximally. While they perform well for some users, their current form limits full functional potential and may put joints proximal to the injury at risk of long-term damage. This study is directed toward designing and testing a lightweight, variable stiffness, dynamic brace that can adjust in response to user activity.
Eligibility Criteria
Inclusion Criteria (Healthy Volunteers):
-able to run continuously for 1 minute
Inclusion Criteria (All Other Volunteers)
* prescribed an offloading Ankle-Foot Orthosis (AFO) for walking/running
* Use prescribed offloading AFO at least 20 hours per week
* Prescribed AFO strut length of at least 200 mm
* Able to run continuously for 1 minute
Exclusion Criteria (Healthy Volunteers):
* limited sensation in the lower limbs
* use an assistive device
Exclusion Criteria (All Other Volunteers):
* Unable to ambulate (walk/run) continuously with AFO for at least 1 minute
* Unable to sit, stand, or negotiate a step onto lab treadmill
Source: ClinicalTrials.gov (NCT04623853). StuddyBuddy aggregates publicly available trial information.