Introduction: Restoration of ambulatory function and the subsequent improvement of health has long been a goal of spinal cord injury (SCI) rehabilitation research. A preliminary pilot study of the use of exoskeletal walking devices performed at the James J. Peters VA Medical Center demonstrated that ten participants with SCI were able to use an exoskeleton to successfully walk for four to six hours per week for three months in a supervised hospital environment. These pilot study participants also demonstrated significant improvement in body composition and improved bowel function. It is unknown if a larger sample of persons with SCI can be taught to walk in these devices with a comparable proficiency and competence, and if they will demonstrate similar medical- and health-related benefits from this intervention. Design: A three-center Phase III, randomized controlled clinical trial (RCT) was performed using a crossover design and employing an exoskeletal-assisted walking intervention. The experimental arm was compared to a usual activities arm, as the control, in 50 persons with chronic SCI (> six months post injury) who were wheelchair-users for community mobility. Primary Aim: To determine changes in exoskeletal assisted walking (EAW) abilities after 36 sessions; Secondary Aims: 1) To improve bowel function as measured by established survey instruments; 2) To reduce total body fat mass and fat percent as measured by dual-energy X-ray absorptiometry (DXA). Exploratory Aims: 1) To improve autonomic/cardiovascular function (vagal tone) measured by the high frequency component of 24-hour heart rate monitoring; 2) In persons with injury level T6 and above, to improve orthostatic tolerance measured by the sit-up-test; 3) To improve HDL-c, Homeostatic Model of Assessment – Insulin Resistance (HOMA-IR), serum total testosterone and estradiol levels measured by serum and plasma assay kits; 4) To improve quality of life (QOL) measured by item banks from the SCI-QOL and Patient Reported Outcomes Measurement Information System (PROMIS). Results: The enrollment goals have been met for this study, the trial has been completed, and data analysis is ongoing. Data will be presented on the enrollment numbers (including number of screen failures and reasons) and the results of the outcome measures listed. Conclusions: The relevance of exoskeletons for implementation in clinical practice including a cost/benefit discussion in the form of an open exchange with the audience will be provided.

Chairperson: Ann M. Spungen, EdD (15 min) Overview of the study design, methods, and consort data (enrolment, screen failures and reasons)
Speaker 1: Peter Gorman, MD (15 min) GI and endocrine results
Speaker 2: Gail Forrest, PhD (15 min) Kinematic/biomechanical results
Speaker 3: Jill M. Wecht, EdD (15 min) Autonomic nervous system results
Chairperson: Ann M. Spungen, EdD (10 min) Summary, discussion of clinical implications and cost/benefit of this technology
Speaker time: 70 min; Q&A: 20 min; Total Workshop time: 90 min
This study was funded be the Department of Defense, Congressional Directed Medical Research Program, Spinal Cord Injury Research Program Clinical Trials (Grant #11501833/SC130234; Dates: 10/2014 to 09/2019). None of the authors have any conflicts of interest to report.