Abstract-Historically, persons with paralysis have limited options for overground ambulation. Recently, powered exoskeletons, which are systems that translate the user's body movements to activate motors that move the lower limbs through a predetermined gait pattern, have become available. As part of an ongoing clinical study (NCT01454570), eight nonambulatory persons with paraplegia were trained to ambulate with a powered exoskeleton. Measurements of oxygen uptake (VO 2 ) and heart rate (HR) were recorded for 6 min each during each maneuver while sitting, standing, and walking. The average value of VO 2 during walking (11.2 +/-1.7 mL/kg/min) was significantly higher than for sitting and standing (3.5 +/-0.4 and 4.3 +/-0.9 mL/kg/min, respectively; p < 0.001). The HR response during walking was significantly greater than that of either sitting or standing (118 +/-21 vs 70 +/-10 and 81 +/-12 beats per minute, respectively; p < 0.001). Persons with paraplegia were able to ambulate efficiently using the powered exoskeleton for overground ambulation, providing the potential for functional gain and improved fitness.Clinical Trial Registration: ClinicalTrials.gov; NCT01454570; "The ReWalk Exoskeletal Walking System for Persons with Paraplegia (VA_ReWalk)"; https://clinicaltrials.gov/ct2/show/ NCT01454570

Background: Individuals with spinal cord injury (SCI) often use a wheelchair for mobility due to paralysis. Powered exoskeletalassisted walking (EAW) provides a modality for walking overground with crutches. Little is known about the EAW velocities and level of assistance (LOA) needed for these devices. Objective: The primary aim was to evaluate EAW velocity, number of sessions, and LOA and the relationships among them. The secondary aims were to report on safety and the qualitative analysis of gait and posture during EAW in a hospital setting. Methods: Twelve individuals with SCI ≥1.5 years who were wheelchair users participated. They wore a powered exoskeleton (ReWalk; ReWalk Robotics, Inc., Marlborough, MA) with Lofstrand crutches to complete 10-meter (10MWT) and 6-minute (6MWT) walk tests. LOA was defined as modified independence (MI), supervision (S), minimal assistance (Min), and moderate assistance (Mod). Best effort EAW velocity, LOA, and observational gait analysis were recorded. Results: Seven of 12 participants ambulated ≥0.40 m/s. Five participants walked with MI, 3 with S, 3 with Min, and 1 with Mod. Significant inverse relationships were noted between LOA and EAW velocity for both 6MWT (Z value = 2.63, Rho = 0.79, P = .0086) and 10MWT (Z value = 2.62, Rho = 0.79, P = .0088). There were 13 episodes of mild skin abrasions. MI and S groups ambulated with 2-point alternating crutch pattern, whereas the Min and Mod groups favored 3-point crutch gait. Conclusion: Seven of 12 individuals studied were able to ambulate at EAW velocities ≥0.40 m/s, which is a velocity that may be conducive to outdoor activity-related community ambulation. The ReWalk is a safe device for in-hospital ambulation.

Powered exoskeletons have become available for overground ambulation in persons with paralyses due to spinal cord injury (SCI) who have intact upper extremity function and are able to maintain upright balance using forearm crutches. To ambulate in an exoskeleton, the user must acquire the ability to maintain balance while standing, sitting and appropriate weight shifting with each step. This can be a challenging task for those with deficits in sensation and proprioception in their lower extremities. This manuscript describes screening criteria and a training program developed at the James J. Peters VA Medical Center, Bronx, NY to teach users the skills needed to utilize these devices in institutional, home or community environments. Before training can begin, potential users are screened for appropriate range of motion of the hip, knee and ankle joints. Persons with SCI are at an increased risk of sustaining lower extremity fractures, even with minimal strain or trauma, therefore a bone mineral density assessment is performed to reduce the risk of fracture. Also, as part of screening, a physical examination is performed in order to identify additional health-related contraindications.Once the person has successfully passed all screening requirements, they are cleared to begin the training program. The device is properly adjusted to fit the user. A series of static and dynamic balance tasks are taught and performed by the user before learning to walk. The person is taught to ambulate in various environments ranging from indoor level surfaces to outdoors over uneven or changing surfaces. Once skilled enough to be a candidate for home use with the exoskeleton, the user is then required to designate a companion-walker who will train alongside them. Together, the pair must demonstrate the ability to perform various advanced tasks in order to be permitted to use the exoskeleton in their home/community environment.

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