A RANDOMIZED, CROSSOVER CLINICAL TRIAL OF EXOSKELETAL-ASSISTED WALKING TO IMPROVE MOBILITY, BOWEL FUNCTION, AND CARDIOMETABOLIC PROFILES IN PERSONS WITH SCI

Project Details

Description

Background/Readiness: Restoration of ambulatory function and the subsequent improvement of health has long been a goal of spinal cord injury rehabilitation research. A preliminary Phase II study of the use of exoskeletal walking devices at our laboratory within the James J. Peters VA Medical Center has demonstrated that 10 participants with spinal cord injury were able to use the ReWalk device to successfully walk for 4 to 6 hours per week for 3 months in the laboratory/hospital environment. These participants also demonstrated significant improvement in body composition, total body weight loss, 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 similar proficiency and competence as demonstrated in our pilot study, and if they can benefit more broadly from this intervention.Objective/Hypothesis: The primary objective of this proposal is to achieve successful walking skills using exoskeletal walking devices over the course of 36 sessions in 3 months at specific velocities and distances in people with chronic SCI who are wheelchair dependent for community mobility. The secondary objectives are to determine if this amount of exoskeletal 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 this intervention 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. For example, if there is a change in HDL-c, total testosterone, and estradiol levels, what is the relationship of this change with fat mass loss and/or is the magnitude of this change related to the achieved mobility and walking skills? Our hypotheses are that (1) this exoskeletal intervention will be successful in training ambulatory skills in this patient population and (2) the exoskeletal intervention will be better than a control group in improving body composition, bowel function, metabolic parameters, and quality of life in the same population.Specific Aims: Primary Aims: (1) By session 12 +/= 3 (first month of WALK training), the participants will be able to perform the following exoskeletal-assisted walking tests with or without minimal assistance: (a) 10 m WT in >/= 60 seconds (>/= 0.17 m/s); (b) 6 min WT distance of >/= 50 m (>/= 0.14 m/s); and/or (c) TUG in /=0.25 m/s); (b) 6 min WT distance >/=80 m (>/=0.22 m/s); and/or (c) TUG in 6 months post-injury) who are wheelchair-dependent for outdoor mobility in the community.Clinical Impact: An intervention such as exoskeletal-assisted ambulation could significantly and positively impact the mobility, activity, and community participation of those with SCI. As these devices become more widely available, the use of exoskeletons could transform the treatment paradigm available to people living with SCI.Military Relevance: Improved upright mobility, health, and well-being may be achieved with exoskeletal-assisted walking on a regular basis. This in turn could lead to a greater number of military personnel with SCI staying on active, non-combat duty or at least returning to work in a wheelchair unfriendly environment.

StatusFinished
Effective start/end date29/09/1428/09/18

Funding

  • Congressionally Directed Medical Research Programs: $1,609,513.00

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