Description:
OBJECTIVE: The objective of this effort is to develop user-worn medical devices to support the rehabilitation of balance disorders, including sensory augmentation/substitution technologies. DESCRIPTION: This SBIR topic seeks to develop innovative concepts for the rehabilitation of balance disorders in military personnel using user-worn devices. Trauma and blast injuries, including traumatic brain injury (TBI), during military service can lead to balance disorders (1). The military has placed an increased emphasis on restoring and rehabilitating injured Warfighters with functional capabilities that provide the ability to return the Warfighter to their duty performance, not just improve a patient"s ability to function in daily life with impairment. Unfortunately, rehabilitative treatments can require long, intensive processes to recover function. Effective short duration, balance rehabilitation strategies and supporting technologies are needed. Envisioned is a short-term treatment course that, once completed, ideally resolves the balance disorder permanently or that might only need to be repeated at very infrequent intervals should the treatment effect wear off. User-worn devices are intended to remove rehabilitation efforts from specialized settings and training/exercise regimens and allow"continuous"rehabilitative treatment while the patient is at home and during routine daily activities. The proposed treatment strategy should ideally return the patient to duty performance levels. Additionally, novel concepts for user-worn assistive devices which provide sensory substitution or augmentation for balance disorders that cannot be rehabilitated may be considered as well. PHASE I: Define a conceptual approach for a technology and employing the technology that meets the intent of the SBIR topic for user-worn balance rehabilitation devices. Phase I deliverable: technical report that outlines the technology approach, establishes the feasibility of the approach using existing data and investigations conducted during Phase I, and a detailed analysis that defines the predicted performance of the end product. PHASE II: Assemble, test and deliver the prototype system(s) defined by the Phase 1 design. Quantifiable performance measures for the technology should be determined that are sufficient to assess the ability to provide an effective treatment. Conduct bench and animal studies in support of testing the technology in humans. Where feasible, conduct a pilot study in humans to assess initial safety and effectiveness of the technology. Develop a plan and cost/time estimate for additional development and clinical study activities required to achieve the FDA and other regulatory approvals required to make the technology commercially available for military clinical use. Phase II deliverables include: prototype system, technical reports documenting the appropriate performance measures for the technology, bench and animal studies conducted, and the pilot clinical study; and a roadmap report that addresses the additional activities and the cost and time required to make the technology commercially available. PHASE III: Technology innovations developed through this SBIR would also have dual use application for balance rehabilitation in the Department of Veterans Affairs and civilian sectors. The technologies would provide for significantly improved capabilities that could also reduce the impact (cost, workload, etc) of providing associated clinical services both in military and non-military settings. REFERENCES: Fausti SA, Wilmington DJ, Gallun FJ, Myers PJ, Henry JA. Auditory and vestibular dysfunction associated with blast-related traumatic brain injury. J Rehabil Res Dev. 2009: 46(6):797-810. (http://www.rehab.research.va.gov/jour/09/46/6/pdf/fausti.pdf)
