Study of a Customized Exoskeletal Orthosis and Rehabilitation Program for Adults with Lower Leg Muscle and Bone Injuries

What this Trial Is About

Researchers are evaluating how a customized exoskeletal orthosis combined with a high-intensity rehabilitation program affects patient outcomes for adults with lower extremity musculoskeletal injuries. This integrated approach, called the Return to Performance clinical pathway, is adapted from a military program originally designed to help combat-wounded soldiers recover function after severe limb injuries. The study aims to explore the impact of this combined orthotic and rehabilitation program in a civilian population using validated functional outcome measures. Participants will receive a custom energy-storing ankle orthosis known as the Intrepid Dynamic Exoskeletal Orthosis IDEO, along with a tailored rehabilitation pathway. This program focuses on improving physical function through specialized therapy and orthotic support. The study observes patients before, during, and after completion of the program to assess changes in their functional abilities. During the study, participants will undergo various assessments including patient-reported outcome measures PROMIS 29 and physical performance tests such as walking speed, stair climbing, and balance at multiple time points baseline, delivery of the orthosis, 3, 6, and 12 weeks after delivery. These tests help researchers understand how the combined orthotic and rehabilitation initiative influences recovery and function over time. The study is observational and includes ongoing monitoring of participants progress throughout these time frames.

Use of an Integrated Orthotic and Rehabilitation Initiative for Treatment of Lower Extremity Musculoskeletal Disorders