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NCT07721792
IM ABLE 2: Injuries Managed With Advanced Bracing for Lower Extremities
Conditions: Lower Limb Injury, Ankle Foot Orthosis (AFO), Lower Limb Trauma
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 75
Sponsor: University of South Florida
Location: University of South Florida, Rehabilitation Robotics & Prosthetics Testbed (RRT) Tampa Florida
Summary
The purpose of the study is to test different categories of ankle foot orthoses (AFOs) with patients who have had lower limb salvage, reconstruction or other problems impacting limb function.
Eligibility Criteria
Inclusion Criteria:
* Lower extremity injury of any etiology requiring current use of an AFO
* Age 18-80 years
* 100-275 lbs
* Greater than 1 month of AFO experience
* Use of an AFO for activities of daily living
* English or Spanish speaking
* Able to comply with study procedures
Exclusion Criteria:
* Body mass less than 100 or greater than 275 lbs.
* Over 80 years of age
* Known cognitive impairment (e.g. diagnoses such as moderate/severe traumatic brain injury, dementia)
* Inability to comply with instructions.
* Pregnancy
* Medical conditions that would preclude safe involvement
* Unable to provide written informed consent.
Source: ClinicalTrials.gov (NCT07721792). StuddyBuddy aggregates publicly available trial information.
