Study of Force Measurement Reliability in Carbon Fiber Orthosis Proximal Cuff for Adults Using Ankle Foot Orthoses

What this Trial Is About

Researchers are studying how forces inside carbon fiber custom dynamic orthoses CDOs can be reliably measured using special sensors called Loadpad and Loadsol. These devices support the foot and ankle, and understanding the forces within the orthosis, especially around the proximal cuff that wraps just below the knee, may improve future research, fitting methods, and patient guidance. The study involves three groups healthy adults using generic CDOs, individuals without peripheral neuropathy who regularly use ankle foot orthoses AFOs, and those with peripheral neuropathy who also use AFOs regularly. Participants will test different tightness levels of the proximal cuff, including self-selected tightness, loose, moderate, and tight fastening. The forces on the leg and foot will be measured using wireless sensors during activities such as sitting quietly, standing, and walking. Group 1 will experience randomized testing of the different cuff tightness, while Groups 2 and 3 will test their usual AFO tightness. The orthosis includes a carbon fiber footplate, posterior strut, and the proximal cuff. Throughout the study, participants will wear the orthoses under various conditions while researchers collect force data and have them complete questionnaires about comfort and pain. Primary measures include forces on the cuff and foot, pain levels, and comfort scores. This study runs from March 2024 through December 2026, with participants undergoing assessments at different cuff tightness levels and activity states to better understand the impact of fastening on orthosis function.

Reliability of Force Measurement Within the Carbon Fiber Orthosis Proximal Cuff