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RECRUITING
NCT07721792
NA

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

Sponsor: University of South Florida

View on ClinicalTrials.gov

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.

Official title: The IM ABLE 2 Study: Long Term Outcomes to Advance Care for Warriors and Veterans Using Advanced Ankle Foot Orthoses

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

75

Start Date

2026-07-31

Completion Date

2029-01-31

Last Updated

2026-07-23

Healthy Volunteers

No

Interventions

DEVICE

Advanced 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.

DEVICE

Conventional 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, United States

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

Tampa, Florida, United States

VA New York Harbor Healthcare System

New York, New York, United States