IM ABLE 2: Injuries Managed With Advanced Bracing for Lower Extremities
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of South Florida
About this trial
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
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Advanced Ankle Foot Orthosis (AFO)
- Conventional Ankle Foot Orthosis (AFO)
Treatment groups
75 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of South Florida
Lead sponsor
Tampa VA Healthcare System
Collaborator
VA New York Harbor Healthcare System
Collaborator
Source ClinicalTrials.gov