An Adjustable Offloading Ankle-Foot Orthosis: Design and Proof-of-Concept Biomechanical Verification

Various ankle-foot conditions (e.g., fractures, diabetic foot ulcers, and post-surgical recovery) require periods of complete non-weightbearing followed by gradually increasing partial loadings. However, existing assistive devices often provide inconsistent or uncomfortable offloading during gait. Additionally, prolonged proximal leg offloading can contribute to muscle atrophy, reduced bone density, and overuse of other body segments. We present a novel offloading ankle-foot orthosis (OLAFO) designed to overcome these limitations. The OLAFO features a patient-specific load-bearing shank brace, designed through a digital workflow and fabricated from a 3D-printed core reinforced with carbon-fiber composite lamination. Interlocking serrated side struts, adjustable in 2 mm increments, modulate load sharing between the shank and plantar surfaces. Furthermore, the OLAFO incorporates contact plates with a rocker profile informed by roll-over-shape measurements to support forward progression and gait symmetry. Proof-of-concept biomechanical verification in one able-bodied participant evaluated complete offloading, five partial-loading levels, and normal gait using a pressure walkway to compute vertical ground reaction forces and impulses. In complete offloading, the affected foot generated no contact pressures. Across partial-loading levels, the foot impulse increased from 14% to 53% of the total load and scaled linearly with strut height adjustments, supporting clinician-prescribed loading increments. Contralateral stance duration increased only modestly compared to commonly used assistive devices, indicating reduced compensatory loading on the intact limb. These findings demonstrate the proof-of-concept feasibility of the OLAFO, highlighting its potential for verifying full offloading and prescribing partial-loading targets during rehabilitation. Future research will evaluate performance across patient populations and clinical rehabilitation tasks.