Exoskeleton Use in Acute Rehab Post Spinal Cord Injury; a Safety and Feasibility Study

Study Overview
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Brief Summary
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This study will examine the safety and feasibility of using an exoskeleton in subjects who are less than 6 months post spinal cord injury (SCI).

Detailed Description
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Study participants with acute SCI (<6 months post injury) will be involved in an indoor, overground walking program. Locomotor training will include 90 minute sessions (including time to don and doff the device) for 30 training hours (90 minutes, 2-3 times weekly for 8 weeks.)

Official Title
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Exoskeleton Use in Acute Rehab Post Spinal Cord Injury; a Safety and Feasibility Study

Conditions
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Spinal Cord Injuries

Intervention / Treatment
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* Device: Exoskeleton


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals aged 15 and older with acute SCI (<6 months post) Etiology of SCI can be traumatic or non traumatic Includes motor complete (AIS A,B) and motor incomplete (AIS C,D) at C7 or below. Participants must be able to follow 2 step commands Participants must be deemed medically stable by responsible physician or physiatrist Spine considered stable by surgeon Surgical wound is approximated and surrounding tissue appears healthy Participant does not require supplemental Oxygen Participant is able to have any IV or other lines disconnected. Must meet manufacturer's requirements for use of Ekso GT: Exclusion Criteria: Range of motion (ROM) restrictions that would prevent a patient from achieving a normal, reciprocal gait pattern, or would restrict a patient from completing normal sit-to-stand or stand-to-sit transitions Spinal instability Untreated deep vein thrombosis (DVT) Decreased standing tolerance due to orthostatic hypotension Significant osteoporosis that prevents safe standing or may increase the risk of fracture caused by standing or walking Uncontrolled spasticity - score of 3 or higher on modified Ashworth Scale Uncontrolled Autonomic Dysreflexia (AD) Skin integrity issues on contact surfaces of the device or on surfaces that would prohibit sitting (sacrum, greater trochanter, proximal tibia) Upper leg length discrepancy greater than half an inch (> .5) or lower leg discrepancy greater than three-quarters of an inch (>.75) Cognitive impairments resulting in motor planning or impulsivity concerns Pregnancy

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Overground walking program<br>Study participant will be involved in an indoor, overground walking program using an exoskeleton wearable walking device under the supervision of a physiotherapist. | Device: Exoskeleton<br>* This is an open study and so all participants involved with be using the exoskeleton to determine the safety and feasibility of its use during the acute rehabilitation phase.<br>* Other names: Ekso GT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline cardiorespiratory status throughout each of the 25 sessions | Blood pressure, heart rate and peripheral oxygen saturation and will be used to identify any cardiovascular issues of orthostatic hypotension or autonomic dysreflexia. | Every 15 minutes during each training session including: pre and post initial stand, at 15 minute intervals during training and at the end of each of the 25 total sessions, on average of 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin integrity | A visual inspection of areas of significant weight bearing and skin/machine interface will take place at the beginning and end of each training session to monitor for skin breakdown or compromise. | At the beginning and end of each training session for 25 sessions, on average of 2 months | 
| Falls | Any incidence of falls will be recorded and the participant will be evaluated for injury by unit medical staff or on site emergency staff if warranted. | From onset to cessation of each training session for 25 sessions, on average of 2 months | 
| Pain visual analogue scale | Participants draw an intersecting line on a 10 cm line (scale) in order to rate their amount of subjective pain. The distance on the 10 cm line is measured from the left side (no pain) and turned into a numerical value. | At the beginning and end of each training session for 25 sessions, on average of 2 months | 
| Borg scale of perceived exertion | Subjects are shown the Borg scale of perceived exertion and are asked to choose the number/descriptor that best aligns with their current level of exertion at 0, 30 and 60 minutes. | At the beginning, mid point (30 min) and end (60 min) of each training session for 25 sessions, on average of 2 months | 
| 10 meter walk test | Time in seconds it takes a subject to walk a distance of 10 meters. | Training sessions 1, 13 and 25 out of the 25 total sessions, on average of 2 months | 
| 6 minute walk test | Total distance a participant is able to walk in 6 minutes will be measured. | Training sessions 1, 13 and 25 of the 25 total sessions, on average of 2 months |