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

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03144830
• Other study ID #: EKSO22214
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: February 2018

Study information

• Verified date: May 2019
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Device:
• Exoskeleton
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.

Locations

Country	Name	City	State
Canada	Foothills Medical Centre	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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