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

University of Calgary1 site in 1 country11 target enrollmentJune 2016

ConditionsSpinal Cord Injuries

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Spinal Cord Injuries
Sponsor: University of Calgary
Enrollment: 11
Locations: 1
Primary Endpoint: Change from baseline cardiorespiratory status throughout each of the 25 sessions
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

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.)

Registry

clinicaltrials.gov

Start Date

June 2016

End Date

February 2018

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University of Calgary

Responsible Party

Principal Investigator

Chester Ho, MD

Associate Professor

University of Calgary

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change from baseline cardiorespiratory status throughout each of the 25 sessions

Time Frame: 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

Blood pressure, heart rate and peripheral oxygen saturation and will be used to identify any cardiovascular issues of orthostatic hypotension or autonomic dysreflexia.

Secondary Outcomes

Skin integrity(At the beginning and end of each training session for 25 sessions, on average of 2 months)
Falls(From onset to cessation of each training session for 25 sessions, on average of 2 months)
Pain visual analogue scale(At the beginning and end of each training session for 25 sessions, on average of 2 months)
Borg scale of perceived exertion(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(Training sessions 1, 13 and 25 out of the 25 total sessions, on average of 2 months)
6 minute walk test(Training sessions 1, 13 and 25 of the 25 total sessions, on average of 2 months)