A Randomized, Crossover Clinical Trial of Exoskeletal-Assisted Walking to Improve Mobility, Bowel Function, and Cardiometabolic Profiles in Persons with SCI
Abstract
The primary objective was to achieve specific walking velocities and distances using a powered exoskeletal at 12 and 36 sessions over the course of 3 months in people with chronic spinal cord injury (SCI) who were wheelchair users for community mobility. The secondary objectives were to determine if this amount of exoskeletal-assisted walking was effective in improving bowel function and body composition. Exploratory objectives included questions concerning the retention or non-retention of changes, effects of increased physical activity on vagal tone, orthostatic tolerance, lipid profile, endogenous hormone levels, and quality of life. To date (Y5, Y4 with a 1-y NCE) the study has achieved the enrollment goals. The number of participants screened, enrolled and completed were as follows: 104 were consented for screening; 71 were randomized; and 50 participants completed the study. Data has been analyzed for the Primary and Secondary objectives and approximately 75% of the exploratory outcome data has been analyzed. Three manuscripts are in preparation: one for the primary outcome of mobility data and one each for the secondary outcomes of bowel and body composition data. Journal submissions for the three main manuscripts is anticipated by March2020. Completion of the exploratory outcomes analyses and manuscript submissions will follow in the summer of 2020.
Document Details
- Document Type
- Technical Report
- Publication Date
- Dec 01, 2019
- Accession Number
- AD1109477
Entities
People
- Ann M. Spungen