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Robotic Exoskeleton With Functional Electrical Stimulation in Acute Spinal Cord Injury
The purpose of this study is to examine the effectiveness of mobility training using the Ekso robotic exoskeleton with functional electrical stimulation (FES) in persons affected by spinal cord injury; designated AIS classification A, B, C, or D. Traditionally, a person with an American Spinal Injury Association Impairment Scale (AIS) "A" injury, walking training is not performed. Even with AIS B, C and D injuries, although walking training may be appropriate, a person may not walk as much as needed to see an improvement due to environmental and staff limitations. The Ekso is a tool to give walking training to patients. The investigators aim to see if utilizing these technologies will affect recovery; specifically in sensation and muscle activity below the level of the injury as well as the ability to walk. The Ekso is a wearable, battery- operated exoskeleton that assists with walking. The Ekso has motors at the hip and knee joints to provide assistance that may be needed with walking. All motion is initiated either through body weight shifts or the use of an external controller. The Ekso robotic exoskeleton has been approved by the Food and Drug Administration as a powered exercise device for rehabilitative purposes such as this study. Currently, the Ekso is approved for people with spinal cord injuries from T4-L5 given bilateral arm strength of 4/5. With injuries from C7-T3, individuals must have AIS classification of D with bilateral arm strength of 4/5. For this study, it is possible that Ekso GT will be used outside of the current FDA approval if the injury level is C7-T3 and the person is classified as an AIS A, B or C injury level. Functional electrical stimulation (FES) will be used in conjunction with the robotic exoskeleton. FES involves using surface electrodes placed on the skin like a sticker over key leg muscles that will be stimulated in the normal walking pattern as a person walks in the device.
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