A Randomized, Crossover Clinical Trial of Exoskeletal-Assisted Walking to Improve Mobility, Bowel Function, and Cardiometabolic Profiles in Persons with SCI

This clinical trial is designed to demonstrate that the walking skills achieved in the preliminary study at the JJPVAMC can be achieved in a larger sample of participants and at three study sites. It is also designed to determine if the body composition and bowel function benefits that were observed with as few as four to six hours per week of walking over three months can be demonstrated in a larger sample. The Phase II trial conducted at the JJPVAMC demonstrated that ten participants were able to use the device to successfully walk for four to six hours per week for three months. It is unknown if a larger sample of persons with SCI can be taught to walk in these devices with a similar proficiency and competence as demonstrated in our pilot study. As such, the primary objectives of this proposal are to achieve successful walking skills in the exoskeletal-assisted walking devices for an extended period of time and at specific velocities and distances over the course of 36 sessions in three months in people with chronic SCI who are wheelchair dependent for community mobility. The secondary objectives are to determine if this amount of walking is effective in improving bowel function and body composition in the same patient population. The exploratory objectives are to address additional questions concerning the retention or non-retention of the positive changes, the effects of the increased physical activity from exoskeletal-assisted walking WALK on vagal tone, orthostatic tolerance, lipid profile, total testosterone, estradiol levels, and quality of life QOL. Other tertiary goals are to explore the relationships among these variables. 14 participants have been randomized across 3 sites thus far, with the first anticipated participant completion being January of 2016.