Comparison between Exercise Program–Foot Orthoses Treatment and Exercise Program Alone after Pilon Fracture Surgery: Study Protocol for a Randomized Controlled Trial

Abstract

The management of tibial pilon fractures is challenging and often leads to complications and limitations in ankle function. The study aims to investigate myotonometric parameters and muscle strength of ankle muscles, as well as gait pattern and balance among patients following surgical treatment of pilon fractures. The randomized controlled study will analyze the differences between the patients who will follow a 3-month physical exercise program and will wear customized foot orthoses (i.e., customized orthotic arch support insoles) versus patients who will attend only the physical exercise program. For each group, at least 21 patients will be required. The assessment involves four different testing procedures: myotonometry (anterior tibialis, medial and lateral gastrocnemius, and longus peroneus assessed using MyotonPRO), muscle strength testing (ankle dorsiflexors, plantar flexors, and peroneal muscles assessed using MicroFET2 dynamometer), analysis of gait parameters (using Scheinworks treadmill), and double-leg and single-leg balance tests (using K-Force plate). After 3 months, the assessments will record which of the two treatments (physical exercise program with or without wearing customized foot orthoses) has better outcomes in regaining ankle muscle properties and tone, as well as the restoration of gait and balance.