Clinical trial NCT03144830: Exoskeleton Use in Acute Rehab Post Spinal Cord Injury; a Safety and Feasibility Study
Official title: Exoskeleton Use in Acute Rehab Post Spinal Cord Injury; a Safety and Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2017-05-09
Enrollment: 11
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.)

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

Primary outcomes:
measure: Change from baseline cardiorespiratory status throughout each of the 25 sessions
timeFrame: 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 outcomes:
measure: Skin integrity
timeFrame: At the beginning and end of each training session for 25 sessions, on average of 2 months
measure: Falls
timeFrame: From onset to cessation of each training session for 25 sessions, on average of 2 months
measure: Pain visual analogue scale
timeFrame: At the beginning and end of each training session for 25 sessions, on average of 2 months
measure: Borg scale of perceived exertion
timeFrame: At the beginning, mid point (30 min) and end (60 min) of each training session for 25 sessions, on average of 2 months
measure: 10 meter walk test
timeFrame: Training sessions 1, 13 and 25 out of the 25 total sessions, on average of 2 months
measure: 6 minute walk test
timeFrame: Training sessions 1, 13 and 25 of the 25 total sessions, on average of 2 months
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
Study officials:
affiliation: University of Calgary
name: Chester Ho, MD
role: PRINCIPAL_INVESTIGATOR
References: