Influence of Prosthetic Foot Stiffness on Transtibial Osseointegrated Bone-Anchored Limb Outcomes

This will be a clinical trial with two groups (individuals with a unilateral transtibial amputation using either an osseointegrated bone-anchored limb or socket prosthesis that will implement a cross-over design. The objective of this clinical trial is to determine how changes in prosthetic foot stiffness influence clinical and biomechanical outcomes in patients with transtibial osseointegrated bone-anchored limbs compared to patients with transtibial amputation using a standard socket-suspended prosthesis. Although proper loading between the bone and implant is pivotal to promote and maintain osseointegration, which is required for physiological loading and thus positive outcomes, evidence surrounding the role of how prosthetic componentry influences force transmission and functional outcomes in this population currently does not exist. The findings of this clinical trial will address a critical knowledge gap pertaining to the role of componentry on multi-loading domain outcomes. Outcomes will be assessed in each participant in the same three conditions: one with their clinical prescribed prosthetic foot, one with a soft prosthetic foot (-2 stiffness categories less than prescribed), and one with a stiff prosthetic foot (+2 stiffness categories more than prescribed). This data will be used to test/develop the following aims: 1) Does foot stiffness change loading between the bone and implant during activities of daily living? 2) Does foot stiffness influence measures of function, pain, and biomechanics in patients with transtibial osseointegrated bone-anchored limbs differently than a socket prosthesis? 3) Does foot stiffness influence sensitivity, balance, and fall risk in patients using an osseointegrated bone-anchored limb different than a socket prosthesis? and 4) (exploratory) develop an optimization platform using computer models to determine the optimal foot stiffness that maximizes joint loading symmetry and minimizes metabolic cost.

• Bone-Implant Dynamic Stress/Strain Impulse (internal) [Срок оценки: Three laboratory visits, each lasting approximately 4 hours, spanning across approximately 6-8 weeks]
• Bone Dynamic Stress/Strain Impulse (internal) [Срок оценки: Three laboratory visits, each lasting approximately 4 hours, spanning across approximately 6-8 weeks]
• Implant Dynamic Stress/Strain Impulse (internal) [Срок оценки: Three laboratory visits, each lasting approximately 4 hours, spanning across approximately 6-8 weeks]
• Prosthesis Force Impulse (external abutment) [Срок оценки: Three laboratory visits, each lasting approximately 4 hours, spanning across approximately 6-8 weeks]
• Sensory Threshold [Срок оценки: Three laboratory visits, each lasting approximately 4 hours, spanning across approximately 6-8 weeks]
• Postural Sway [Срок оценки: Three laboratory visits, each lasting approximately 4 hours, spanning across approximately 6-8 weeks]
• Reactive Postural Control Time [Срок оценки: Three laboratory visits, each lasting approximately 4 hours, spanning across approximately 6-8 weeks]
• Whole-Body Angular Momentum [Срок оценки: Three laboratory visits, each lasting approximately 4 hours, spanning across approximately 6-8 weeks]
• Self-Selected Gait Speed [Срок оценки: Three laboratory visits, each lasting approximately 4 hours, spanning across approximately 6-8 weeks]
• L-Test Time [Срок оценки: Three laboratory visits, each lasting approximately 4 hours, spanning across approximately 6-8 weeks]
• Acceptability of Intervention Measure [Срок оценки: Three laboratory visits, each lasting approximately 4 hours, spanning across approximately 6-8 weeks]
• Prosthetic Limb Users Survey of Mobility [Срок оценки: Three laboratory visits, each lasting approximately 4 hours, spanning across approximately 6-8 weeks]