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Completed

NCT Number: NCT03144830

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

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).

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Key information

Conditions

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

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Foothills Medical Centre

Calgary, Alberta, T2N2T9, Canada

About this study

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.)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Ekso GT

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 9, 2017
Registry last updated
May 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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