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NCT07721792NARecruiting

IM ABLE 2: Injuries Managed With Advanced Bracing for Lower Extremities

University of South Florida

Start Date

7/31/2026

Completion Date

1/31/2029

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.

Detailed 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. Over the course of a year, subjects will test both AFO types; a conventional (standard) AFO and an advanced (energy storing and return) AFO, in a battery of physical tests, community use, and surveys to gain a better understanding of the pros and cons of each. Subjects will be recruited to participate in research for approximately 18 months. During the first six weeks (up to three weeks on each type of AFO), subjects will be provided with an AFO and given training on how to correctly use and maintain it, to ensure optimal use. Over the following 12 months, there will be monthly assessments including questionnaires, activity monitor uploads, device failures, and interviews to gather information on the subject's experience with AFO use.

Eligibility Criteria

Age Range: 18 years to 80 years

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.

Interventions

DEVICE

Advanced Ankle Foot Orthosis (AFO)

DEVICE

Conventional Ankle Foot Orthosis (AFO)

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Conditions

Lower Limb InjuryAnkle Foot Orthosis (AFO)Lower Limb Trauma

Locations

University of South Florida, Rehabilitation Robotics & Prosthetics Testbed (RRT)

Tampa, Florida 33620

United States

James A. Haley VA Center of Innovation of Disability & Rehab Research

Tampa, Florida 33637

United States

VA New York Harbor Healthcare System

New York, New York 10010

United States