Using a Health Technology Assessment Framework for Evaluating the Utilization and Efficiency of Wearable Exoskeletons for SCI Rehabilitation, is persons with SCI at the C7 to S1 level, designated AIS A to D.

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Allen Heinemann/ David Chen
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Robotic exoskeletons provide several advantages over conventional therapy and treadmill robot-based approaches including the potential to decrease the physical burden on therapists and reduce labor costs compared to conventional therapy while achieving similar functional and health outcomes to conventional therapy. In contrast to treadmill robot-based approaches, exoskeletons enable mobility in home and community settings for individuals who may not achieve this level of function with conventional therapy alone. However, evidence for the effective-ness and cost effectiveness of these devices is limited, and optimal ways of deploying therapists and robots are not defined. De-spite limited evidence of superiority of these devices over conventional therapy; sales of rehabilitation robotics continue to grow, making this a critical area of study. The purpose of this study is to evaluate both the utility and the costs of robotic exoskeleton-based therapy (RT-exo) in rehabilitation and community settings. This study will examine the utilization and evaluate the effectiveness and efficiency of RT-exo and evaluate the business case for more widely available RT-exo services. We will assess the efficiency of RT-exo using a budget impact analysis, where we will model the shift in re-sources from a system perspective once RT-exo is introduced into the conventional treatment mix. The goal of this collaborative module is to obtain evidence that informs consumers, clinicians, insurers, and manufacturers about the utilization and cost-effectiveness of RT-exo in inpatient, outpatient, and community settings. Findings will inform clinical practice, guide commercial development of rehabilitation robots, and assist in planning of clinical trials. We propose 3 aims: Aim 1: Describe the physical, psychological, demographic, and socio-economic characteristics, and insurance coverage of patients who receive RT-exo therapy vs. patients receiving conventional therapy. Aim 2: Compare the treatment goals and outcomes of patients who receive RT-exo therapy vs. conventional therapy in terms of functional goals and targeted impairments using performance-based measures (motor strength, endurance, gait characteristics), and patient-reported outcomes stratified by injury level, completeness, and chronicity. Aim 3: Evaluate the cost effectiveness and budget impact of RT-exo therapy vs. conventional therapy to the individual, the health care system, and society.