ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03144830
Recruitment Status : Recruiting
First Posted : May 9, 2017
Last Update Posted : May 9, 2017
Sponsor:
Information provided by (Responsible Party):
Chester Ho, MD, University of Calgary

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).

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Device: Exoskeleton Not Applicable

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.)


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Exoskeleton Use in Acute Rehab Post Spinal Cord Injury; a Safety and Feasibility Study
Study Start Date : June 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Overground walking program
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
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.
Other Name: Ekso GT



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Skin integrity [ Time Frame: At the beginning and end of each training session for 25 sessions, on average of 2 months ]
    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.

  2. Falls [ Time Frame: From onset to cessation of each training session for 25 sessions, on average of 2 months ]
    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.

  3. Pain visual analogue scale [ Time Frame: At the beginning and end of each training session for 25 sessions, on average of 2 months ]
    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.

  4. Borg scale of perceived exertion [ 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 ]
    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.

  5. 10 meter walk test [ Time Frame: Training sessions 1, 13 and 25 out of the 25 total sessions, on average of 2 months ]
    Time in seconds it takes a subject to walk a distance of 10 meters.

  6. 6 minute walk test [ Time Frame: Training sessions 1, 13 and 25 of the 25 total sessions, on average of 2 months ]
    Total distance a participant is able to walk in 6 minutes will be measured.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03144830


Contacts
Contact: Chester Ho, MD (403) 944 2061 chester.ho@ahs.ca
Contact: Kyle McIntosh, MScPT (403) 944 5358 kyle.mcintosh@ahs.ca

Locations
Canada, Alberta
Foothills Medical Centre Recruiting
Calgary, Alberta, Canada, T2N2T9
Contact: Kyle J McIntosh, MScPT    403-944-5358    kyle.mcintosh@ahs.ca   
Sponsors and Collaborators
University of Calgary
Investigators
Principal Investigator: Chester Ho, MD University of Calgary

Responsible Party: Chester Ho, MD, Associate Professor, University of Calgary
ClinicalTrials.gov Identifier: NCT03144830     History of Changes
Other Study ID Numbers: EKSO22214
First Posted: May 9, 2017    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System