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

University of Calgary

Status: Completed

Conditions: Spinal Cord Injuries

Treatments: Device: Exoskeleton

Study type: Interventional

Funder types: Other

Identifiers

NCT03144830

EKSO22214

Details and patient eligibility

About

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).

Full description

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.)

Enrollment: 11 patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

Overground walking program

Experimental group

Description:

Study participant will be involved in an indoor, overground walking program using an exoskeleton wearable walking device under the supervision of a physiotherapist.

Treatment:

Device: Exoskeleton