The IM ABLE 2 Study: Long Term Outcomes to Advance Care for Warriors and Veterans Using Advanced Ankle Foot Orthoses
University of South 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.
Description
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. Some lower limb AFO users will decide later to amputate the affected limb to escape pain and repeated surgery requiring them to use a prosthesis instead. Benefits may include reduced pain and more function from a prosthesis. This research will allow physicians, physical therapists, orthotists, and researchers to determine what modifications can be made to AFOs to make them more comfortable and usable. Ov…
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
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 * Unabl…
Interventions
- DeviceAdvanced Ankle Foot Orthosis (AFO)
Subjects will be initially fit with the AFO category they do not use on a daily basis to ensure they have both AFO categories for the study. These "advanced" AFOs have been developed to offer energy-storing-and-returning (ESR) properties to the user. Advanced Ankle Foot Orthoses include designs that are widely believed to return stored energy in late stance. These designs are laminated and may include posterior struts.
- DeviceConventional Ankle Foot Orthosis (AFO)
Subjects will be initially fit with the AFO category they do not use on a daily basis to ensure they have both AFO categories for the study. Conventional Ankle Foot Orthoses have been more commonly used in past decades. AFOs within the conventional category generally include designs that will not return stored energy in late stance. These designs may vary in material construction and componentry. For instance, mechanical joints can be incorporated but do not have to be for inclusion in this group. AFOs in this category may be thermoplastic materials or thermoset laminate. The devices may be off-the-shelf or custom molded to the patient.
Locations (3)
- University of South Florida, Rehabilitation Robotics & Prosthetics Testbed (RRT)Tampa, Florida
- James A. Haley VA Center of Innovation of Disability & Rehab ResearchTampa, Florida
- VA New York Harbor Healthcare SystemNew York, New York