Robotic Exoskeleton With Functional Electrical Stimulation in Acute Spinal Cord Injury

Summary

Participation Requirements

Description

The purpose of this study is to examine the effectiveness of mobility training using the Ekso robotic exoskeleton with functional electrical stimulation (FES) on neural recovery in individuals with acute spinal cord injury with American Spinal Injury Association Impairment Scale (AIS) neurologic cla...

The purpose of this study is to examine the effectiveness of mobility training using the Ekso robotic exoskeleton with functional electrical stimulation (FES) on neural recovery in individuals with acute spinal cord injury with American Spinal Injury Association Impairment Scale (AIS) neurologic classification A, B, C or D. Specifically, individuals with acute SCI in the inpatient rehabilitation setting improve their AIS score after mobility training with the Ekso-FES compared to a control intervention period? In addition, the investigators will analyze the influence of training performed early or later in acute rehabilitation phase on muscle properties, neural recovery and function. This is an investigational clinical study trialing the efficacy of the Ekso device with FES in the acute SCI population. Participants with a diagnosis of spinal cord injury classified as AIS A, B, C or D will be included. Up to ten participants will be recruited to participate in this study. This number was arbitrarily chosen as this is an investigational study and there is no previous data on the Ekso device to specifically select subject number based on a power analysis. Participants will be recruited from inpatient units at The Shirley Ryan AbilityLab. Following screening, all subjects will be required to receive medical clearance from their attending inpatient physician. Subjects will be randomized to which order they receive the Ekso intervention (A) and control (B) period (A then B or B then A). The device will be used in the lab and there will be no charge associated with use of the Ekso device. All participants involved in the investigational study/training will be screened according to general inclusion/exclusion criteria after obtaining informed consent and before using the Ekso device. Screening will include: Range of Motion (ROM): Range of motion of the joints of the upper and lower extremities will be measured using a goniometer Muscle strength testing: upper and lower extremity manual muscle testing to determine qualification for study inclusion. Modified Ashworth Scale (MAS): The Modified Ashworth Scale is a 6 point ordinal scale used to grade the amount of hypertonicity in individuals with neurological diagnoses. A score of 0 on the scale indicates no increase in tone while a score of 4 indicates rigidity. Tone is scored by passively moving the individual's limb and assessing the amount of resistance to movement felt by the examiner. Upper and lower leg length and hip measurements will be performed to determine safe fit in the exoskeleton device.

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