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There are more than 300,000 estimated cases of spinal cord injury (SCI) in the United States, and approximately 27,000 of these are Veterans. Immobilization from SCI results in adverse secondary medical conditions and reduced quality of life. Veterans with SCI who have completed rehabilitation after injury and are unable to ambulate receive a wheelchair as standard of care. Powered exoskeletons are a technology that offers an alternative form of limited mobility by enabling over-ground walking through an external framework for support and computer-controlled motorized hip and knee joints. Few studies have reported the safety and efficacy for use of these devices in the home and community environments, and none evaluated their impact on patient-centered outcomes through a randomized clinical trial (RCT). Absence of reported RCTs for powered exoskeletons may be due to a range of challenges, including designing, statistically powering, and conducting such a trial within an appropriate experimental framework. An RCT for the study of exoskeletal-assisted walking in the home and community environments also requires the need to address key factors such as: avoiding selection bias, participant recruitment and retention, training, and safety concerns, particularly in the home environment. These points are described here in the context of a national, multisite Department of Veterans Affairs Cooperative Studies Program-sponsored trial. The rationale and methods for the study design were focused on providing a template for future studies that use powered exoskeletons or other strategies for walking and mobility in people with immobilization due to SCI.

Objective To determine the effects of a 24-month program of Individual Placement and Support (IPS) supported employment (SE) on employment outcomes for veterans with spinal cord injury (SCI). Design Longitudinal, observational multisite study of a single-arm, nonrandomized cohort. Setting SCI centers in the Veterans Health Administration (n=7). Participants Veterans with SCI (N=213) enrolled during an episode of either inpatient hospital care (24.4%) or outpatient care (75.6%). More than half the sample (59.2%) had a history of traumatic brain injury (TBI). Intervention IPS SE for 24 months. Main Outcome Measure Competitive employment. Results Over the 24-month period, 92 of 213 IPS participants obtained competitive jobs for an overall employment rate of 43.2%. For the subsample of participants without TBI enrolled as outpatients (n=69), 36 obtained competitive jobs for an overall employment rate of 52.2%. Overall, employed participants averaged 38.2±29.7 weeks of employment, with an average time to first employment of 348.3±220.0 days. Nearly 25% of first jobs occurred within 4 to 6 months of beginning the program. Similar employment characteristics were observed in the subsample without TBI history enrolled as outpatients. Conclusions Almost half of the veterans with SCI participating in the 24-month IPS program as part of their ongoing SCI care achieved competitive employment, consistent with their expressed preferences at the start of the study. Among a subsample of veterans without TBI history enrolled as outpatients, employment rates were >50%. Time to first employment was highly variable, but quite long in many instances. These findings support offering continued IPS services as part of ongoing SCI care to achieve positive employment outcomes.