The largest burden of injury from recent conflicts is extremity trauma, which impacts mobility, function, community participation, and quality life. Ankle-foot orthoses (AFOs) are often necessary to overcome some of the limitations related to lower limb musculoskeletal trauma. There is broad array of AFOs on the market today, but limited evidence-based information to guide their prescription. The clinician must rely on intuition, training, experience, and qualitative manufacturer-produced guides to match the right device to a patient. Patients must rely on the guidance of the clinician and have limited ability to trial different AFOs. The inability to 'test-drive' different designs is an unmet clinical need that is holding back patient care. This study will investigate a test-drive strategy using a programmable robotic exoskeleton (an AFO emulator) that can mimic the behavior of AFOs, allowing patients to quickly 'try-on' multiple different devices without having to physically change devices. This provides the user with the experience of swapping out different design features in real time without the costly and time-intensive trial and error process of comparing actual devices. We aim to test the ability of the AFO emulator to predict user function, mobility, and preference outcomes with commercially available AFOs in Service Members and Veterans with lower limb musculoskeletal trauma. We propose a 4-year clinical trial to investigate this aim using short-term, in-lab comparisons between actual and emulated AFOs, and also a long-term comparison of how well an initial AFO emulate test-drive session can predict preference and satisfaction of using the actual AFO for several weeks. We will additionally allow users to fine-tune the AFO emulator settings to identify their own 'optimal' AFO. This will be compared to their actual clinically prescribed AFO to determine if the AFO emulator can improve the preference for a device over the standard of care.
The proposed approach to AFO prescription could resolve the longstanding uncertainty in the prescription process. It will directly impact Service Member and Veteran AFO users with lower limb musculoskeletal injuries by providing a potential improvement to the standard of care prescription process for AFOs. This patient-centered approach gives the user a new tool for far greater participation in the clinical decision-making process than has been previously possible. Providing patients with a way of becoming a more active part of the decision-making process will likely increase buy-in, encourage them to remain invested in their care, improve both mobility and satisfaction with the prescribed AFO device, and help them reach functional goals. This is particularly important for the Service Member transitioning to care in the VA. Service Members with severe trauma are often highly active and young at the time of injury and can expect a lifetime of care related to their injury. Providing a strategy to improve care early in this process may elicit longstanding benefits across the lifetime and delay or prevent the development of secondary disabling conditions. The intended impacts of this work also include saving clinicians time, improving patient outcomes, improving reimbursement justification, lowering healthcare costs, and informing future device development.
|Effective start/end date||1/01/20 → …|
- Congressionally Directed Medical Research Programs: $2,723,384.00