A Randomized, Crossover Clinical Trial of Exoskeletal Assisted Walking to Improve Mobility, Bowel Function, and Cardiometabolic Profiles in Persons with SCI
Technical Report,29 Sep 2015,28 Sep 2016
BRONX VETERANS MEDICAL RESEARCH FOUNDATION INC (VETERANS AFFAIRS) NEW YORK BRONX United States
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The primary objective is to achieve specific walking velocities and distances using a powered exoskeletal over the course of 36 sessions in 3 months in people with chronic SCI who are wheelchair users for community mobility. The secondary objectives are to determine if this amount of exoskeletal-assisted walking is effective in improving bowel function and body composition. Exploratory objectives include questions concerning the retention or non-retention of the positive changes, effects of increased physical activity on vagal tone, orthostatic tolerance, lipid profile, total testosterone, estradiol levels, and quality of life. During this research period year 2, 42 participants were consented for Screening 14 of which were screen failures. The Screening failure reasons included low bone mineral density 6, schedule conflicts 4, contractures 2, SCI level exclusion 1, and severe spasticity 1. The remaining 28 participants were randomized. The first 10 participants to complete both arms of the study were analyzed for preliminary data for the primary outcome variables. In these first 10 participants, 60 were able to walk 0.25 ms at 12 sessions and 70 achieved this velocity at 36 sessions. Of note, 30 of the participants achieved a velocity of 0.40 ms the FDA requirement for personal prescription.
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