Physical Activity-Quality of Life Research-Exsoskeletal Assisted Walking
Investigator: Ann M. Spungen, Ed.D
Lack of mobility and accessibility makes exercising quite difficult for persons with SCI. Our investigators are studying exoskeletal-assisted walking as a form of exercise and mobility. The impact regular walking in these devices has on health and quality of life in persons with paralysis from SCI is also being investigated.
Broadcast of The Discovery Channel - Canada
For someone who cannot stand or walk, robotic exoskeletal technology allows not only a newfound mobility and independence, but it also provides a method to improve general health after spinal cord injury. Dr. Spungen is investigating the myriad medical benefits that this mechanical device offers its users, as well as questions related to its safety with daily usage in hospital and home/community settings.
Currently, the treatment of muscle and bone deterioration after SCI is very limited; therefore, there is a definite need to further understand the mechanism of breakdown in the musculoskeletal system after a SCI, and, more importantly, find a clinical strategy that will treat muscle and bone loss.
This pilot research grant will collect results that will be used for the design of a multi-site randomized controlled clinical trial to determine whether a Robotic Exoskeleton training [100 sessions; 1hr/session; 4-5 sessions/week] can improve musculoskeletal outcomes more than other current interventions. If the overall objective is to use the progression of technology to enhance functional ambulation for persons with a spinal cord injury, then the investigators need to evaluate the health benefits associated with continual use of the device.
The study will be a prospective, single-group, repeated measure design using a 2 -month lead in to establish stability, 5-month intervention phase and 2 -month follow-up phase for retention will be performed. Each participant will be used as his or her own control. This project will be completed at two sites: Kessler Foundation will be the lead site that will be under the direction of Dr. Gail F Forrest (Principal Investigator) and Spinal Cord Damage Research Center, James J Peters VA Medical Center under the direction of Dr. Ann M. Spungen (collaborator). Both sites have exoskeletal-assisted walking programs.
The primary objective of this study 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).
A Phase III randomized clinical trial (RCT) will be performed using a crossover design and employing an exoskeletal-assisted walking intervention. The experimental arm will be compared to a usual activities (UA) arm, as the control, in 64 persons with chronic SCI (>6 month post injury) who are wheelchair-dependent for outdoor mobility in the community. The WALK arm will consist of supervised exoskeletal-assisted walking training, three sessions per week (4-6 h/week) for 36 sessions for their second 12-week period. The UA arm will consist of identification of usual activities for each participant, encouragement to continue with these activities and attention by study team members throughout the 12-week UA arm. These activities will be recorded in a weekly log. The investigators hypotheses are that 1) this exoskeletal intervention will be successful in training ambulatory skills in this patient population, 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.
Background Veterans with spinal cord injury (SCI) have many adverse secondary medical and quality of life (QOL) changes as a result of immobilization. Veterans with SCI who have completed rehabilitation after injury and are unable to ambulate receive a wheelchair as standard of care (SOC) for mobility. Powered exoskeletons are a technology that has recently become available as an alternate form of mobility by providing an external framework for support and computer controlled motorized hip and knee joints to assist with over ground ambulation.