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

NCT03144830 | Completed

• 1 other identifier: EKSO22214
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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).

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Study Arms (1)

Overground walking program

EXPERIMENTAL

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

Interventions

Exoskeleton DEVICE

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.

Also known as: Ekso GT

Overground walking program

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

Foothills Medical Centre

Calgary, Alberta, T2N2T9, Canada

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Exoskeleton Device

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Chester Ho, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 20, 2016
• First Posted: May 9, 2017
• Study Start: June 1, 2016
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: May 16, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)