- Durability and Material Quality
- Tensile and Shear Stress tests: These stresses are assessed to determine the material's performance under load, with expected tensile stresses around 0.11 MPa at the heel and shear stresses peaking at approximately 0.28 MPa in the neck region.
- Parameters: The maximum stresses remain below the material's yield strength, ensuring that the ABS-PC behaves predictably under load without permanent deformation.
- Fatigue Testing: For this test here, the device is put through 1,000,000 cycles of loading and unloading, in order to mimic months of walking and, thereby, examine the issue of material wear out.
- Abrasion Resistance Test: Check how the surface material endures abrasion because of friction arising from frequent contact with other objects.
- Parameters:
- Cycles to Failure: It is essential to make the orthosis to last for at least one million cycles of load before the wear appears.
- Material Degradation Rate: On average, fewer than 5% wear after a simulated month of use.
- Expected outcome: Thus, the orthosis should be able to endure constant use and daily wear and tear without degrading quickly.
- Displacement test:
- Testing methods: This is determined at critical points of the orthosis, particularly at the arch and heel, with expected maximum displacements not exceeding 5 mm under load conditions simulating a weight range of 75-85 kg.
- Parameters: The results should indicate that maximum displacements remain within acceptable limits (e.g., ≤ 5 mm), confirming that the orthosis provides adequate support without excessive flex or instability during use.
- Expected outcome: It is expected that the orthosis will demonstrate excellent elastic recovery characteristics, returning to its original shape after load removal, which indicates good material performance and longevity.
- Peak Plantar Pressure Mapping:
- Testing Method: Pressure is applied on the orthosis design mapping systems while assessing the plantar pressures during gait assessment.
- Parameters: Maximum pressures at the the heel and forefoot regions should range between 145 kpa to 250 kpa(Pressure 4) during heel strike and toe off while maximum pressures at the midfoot should range between 25kpa and 50kpa (Pressure 3) during midstance.
- Expected Outcome: The orthosis should help reduce the maximum pressure that patients with flatfoot put on their plantar fascia, especially in the forefoot and the arch height area.
- Arch Support Efficacy:
- Testing Method: Will check the height of the arch supports, employing 3D motion analysis during the dynamic movement.
- Parameters: Documented any changes in the height of the arch of the foot and alignment of feet pre and post, orthosis usage.
- Expected Outcome: Increased arch support should correlate with improved foot posture and reduce strain on the plantar fascia.