Study Comparing Advanced and Conventional Ankle Foot Orthoses for Adults with Lower Limb Injuries to Evaluate Function and Long-Term Outcomes

What this Trial Is About

Researchers are studying different types of ankle foot orthoses AFOs in adults who have had lower limb salvage, reconstruction, or other problems affecting limb function. The study aims to compare conventional AFOs with advanced energy-storing-and-returning AFOs to find out which type may better reduce pain and improve function for people with lower limb injuries. This research will help healthcare providers modify AFOs to make them more comfortable and useful for patients. Participants will test both AFO types during the study. Initially, each participant will be fit with the AFO category they do not usually use to ensure they try both types. Each AFO is worn for up to three weeks with training on proper use and maintenance. After these accommodation periods, participants will continue using the devices for up to one year, with monthly assessments to gather information about their experience, including physical tests, surveys, and activity monitoring. During the study, participants will complete various physical performance tests such as the Timed Up & Go, Two-minute Walk Test, and Four-Square-Step-Test after each AFO accommodation period. They will also complete balance confidence scales and patient-reported surveys monthly for a year. Researchers will collect data on device usage, failures, and participant feedback through interviews to understand preferences and outcomes. The total study participation lasts about 18 months.

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