Back to resultsExoskeleton Use in Acute Rehab Post Spinal Cord Injury; a Safety and Feasibility Study
Primary Purpose
Spinal Cord Injuries
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Exoskeleton
Sponsored by
About this trial
This is an interventional health services research trial for Spinal Cord Injuries
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
Sites / Locations
- Foothills Medical Centre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Overground walking program
Arm Description
Study participant will be involved in an indoor, overground walking program using an exoskeleton wearable walking device under the supervision of a physiotherapist.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
10 meter walk test
Time in seconds it takes a subject to walk a distance of 10 meters.
6 minute walk test
Total distance a participant is able to walk in 6 minutes will be measured.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03144830
Brief Title
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
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
June 2016 (undefined)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
February 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Calgary
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Overground walking program
Arm Type
Experimental
Arm Description
Study participant will be involved in an indoor, overground walking program using an exoskeleton wearable walking device under the supervision of a physiotherapist.
Intervention Type
Device
Intervention Name(s)
Exoskeleton
Other Intervention Name(s)
Ekso GT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline cardiorespiratory status throughout each of the 25 sessions
Description
Blood pressure, heart rate and peripheral oxygen saturation and will be used to identify any cardiovascular issues of orthostatic hypotension or autonomic dysreflexia.
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
Secondary Outcome Measure Information:
Title
Skin integrity
Description
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.
Time Frame
At the beginning and end of each training session for 25 sessions, on average of 2 months
Title
Falls
Description
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.
Time Frame
From onset to cessation of each training session for 25 sessions, on average of 2 months
Title
Pain visual analogue scale
Description
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.
Time Frame
At the beginning and end of each training session for 25 sessions, on average of 2 months
Title
Borg scale of perceived exertion
Description
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.
Time Frame
At the beginning, mid point (30 min) and end (60 min) of each training session for 25 sessions, on average of 2 months
Title
10 meter walk test
Description
Time in seconds it takes a subject to walk a distance of 10 meters.
Time Frame
Training sessions 1, 13 and 25 out of the 25 total sessions, on average of 2 months
Title
6 minute walk test
Description
Total distance a participant is able to walk in 6 minutes will be measured.
Time Frame
Training sessions 1, 13 and 25 of the 25 total sessions, on average of 2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chester Ho, MD
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Foothills Medical Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N2T9
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Exoskeleton Use in Acute Rehab Post Spinal Cord Injury; a Safety and Feasibility Study
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