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Portable Technology to Assess Ankle Instability


OUSD (R&E) CRITICAL TECHNOLOGY AREA(S): OPERATIONAL MEDICINE OBJECTIVE: Improve service member readiness by objectively assessing ankle instability with technology that is portable and can be used by minimally trained personnel in the area of lower limb movement and ankle injuries. DESCRIPTION: The DoD seeks the capability to optimally and rapidly return to duty the high rates of Warfighters with destabilizing lower limb injuries. In the United States, approximately 25,000 ankle sprains occur daily (Bernstein, 2003). The rate of ankle sprains in military personnel is nearly five times greater than that reported in the civilian population (Cameron et al, 2010). Given the high prevalence of ankle sprains, there is a need for effective preventative and rehabilitative options in order to minimize the impact of ankle injuries on Warfighter readiness and lethality. Only 1 in 4 persons who incur an ankle injury receive rehabilitation. It is critical that these be diagnosed as soon as possible to get people to care early, when they are most likely to benefit. The probability of ankle sprain recurrence increases for each day that rehabilitation is not provided during the first week after injury (Rhon et al, 2021). In addition, up to 40% of persons who incur an ankle sprain do not fully heal and develop chronic ankle instability. Technology that can monitor for ankle sprains and evaluate ankle instability could help by assessing occurrence of injury, preventing further injury, and/or determine the success of therapy. The capability should objectively assess destabilizing ankle injuries that occur in both the operational and training environments. This capability would provide objective measurement of ankle instability and its progression/resolution over time. Currently, self-report questionnaires, magnetic resonance imaging (MRI) or radiographs, and/or subjective assessment by an experienced clinician are the current methods for identifying chronic ankle instability. Arthrometers that assess laxity are bulky and impractical in many clinical settings. Instrumented measures that can capture resolution of ankle-foot impairment are desired. PHASE I: Design/develop a new concept that will objectively measure ankle instability. A solution is sought that is portable, can be used without an external power source, is easy to use by both clinicians and non-clinicians, is capable of measuring changes due to injury, healing and/or clinical intervention, and provides a visual display. The solution should demonstrate clear understanding of ankle and soft tissue mechanics and decrements due to injury. Solutions are intended to be used within the operational environment, training environment, and/or clinical care setting. It should require minimal setup, be easy to administer, and have understandable outcome metrics. Desirable solutions may be used in austere environments at or near the time of injury occurrence. The solution is intended to augment clinical expertise, laxity tests, patient-reported measures, and performance tests for rehabilitation progress or re-injury. PHASE II: Design and develop the practical implementation of the product that implements the previously completed Phase I methodology towards a technology that is sufficiently sensitive to monitor and/or measure ankle injury and instability over time. Demonstrate that the developed solution is capable of accurately making these measurements and correlates with current subjective clinical assessments. Define field test objectives and conduct limited testing. Assess the validity of the technology and provide intra-rater and inter-rater reliability of the product. The testing and practical implementation of the product should be relevant to Warfighters who have experienced destabilizing ankle injuries (e.g. sprains) in training or operational settings. Solutions that rely solely on imaging of the underlying tissues do not meet the intent of the solicitation. Extended wear or use is not required. The expected Phase II end-product is a well-designed, portable product to be used in clinical, as well as research, settings. The investigator shall also describe in detail the transition plan for the Phase III effort. The offeror shall prepare the regulatory strategy and provide a clear plan on how FDA clearance will be obtained. PHASE III DUAL USE APPLICATIONS: Investigators may work with commercial and military partners, and/or in the civilian marketplace to move towards a final commercial product that will be capable of accurately assessing ankle instability. For example, sports medicine. The system should be capable of generating an output report that meets the needs of the end user (or can be modified and customized to these needs). The investigator should ensure that the final product can be incorporated into clinical practice, including the considerations of ease of use, appropriate coding/billing, cost/benefit, and training, education, socialization, and outreach. Plans on the commercialization/technology transition and regulatory pathway should lead to eventual FDA clearance/approval. REFERENCES: 1. Bernstein, J. ed., 2003. Musculoskeletal medicine (Vol. 1). Amer Academy of Orthopaedic; 2. Cameron, K.L., Owens, B.D. and DeBerardino, T.M., 2010. Incidence of ankle sprains among active-duty members of the United States Armed Services from 1998 through 2006. Journal of athletic training, 45(1), pp.29-38; 3. Rhon, D.I., Fraser, J.J., Sorensen, J., Greenlee, T.A., Jain, T. and Cook, C.E., 2021. Delayed Rehabilitation Is Associated With Recurrence and Higher Medical Care Use After Ankle Sprain Injuries in the United States Military Health System. Journal of Orthopaedic & Sports Physical Therapy, 51(12), pp.619-627; KEYWORDS: Ankle instability, Balance, Sprain, Musculoskeletal injury, Lower extremity, Rehabilitation, Soft tissue injury
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