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Restoring Walking With a Powered Exoskeleton After Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT02322125
Recruitment Status : Completed
First Posted : December 22, 2014
Last Update Posted : June 19, 2019
Sponsor:
Information provided by (Responsible Party):
University of Alberta

Brief Summary:
Powered exoskeletons have emerged recently, promising to offer walking to individuals with severe spinal cord injury who are unable to walk. We will use the ReWalk exoskeleton to train walking in individuals with chronic, severe spinal cord injury. We will determine the characteristics of individuals who most benefit from such training, and identify the neuroplasticity induced by the training. We will further determine the feasibility of the ReWalk for home and community ambulation.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Device: ReWalk Not Applicable

Detailed Description:

A prospective, pilot, cohort study design will recruit participants to train intensively for a 3 month period. The training sessions will be documented in detail, including number of steps taken, speed of walking, distance of walking. Once walking speed has plateaued, we will evaluate the feasibility of using the device in a home-like environment and in the community.

At the end of this study, we will have a good idea of the capability of the ReWalk to assist walking in those with severe SCI. We will better understand which individuals are most likely to benefit from the ReWalk. We will know how training in the ReWalk changes the neural connections between the brain and the spinal cord so that we can better guide the training protocol. Finally, we will identify limitations of the ReWalk for home and community use, so that exoskeletons can be improved in the future to maximize their benefit to people with SCI.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Restoring Walking With a Powered Exoskeleton After Spinal Cord Injury
Study Start Date : June 2014
Actual Primary Completion Date : July 30, 2018
Actual Study Completion Date : September 26, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ReWalk training
ReWalk exoskeleton training: 1.5 hr/day, 4 days/week, for 12-14 weeks (approximately 50 training sessions). Participants will progress through the following: sit-to-stand, stand-to-sit, standing balance and weight shift, walking on smooth ground, stopping, turning while walking, walking on rough ground, ascending and descending slopes, ascending and descending steps and curbs.
Device: ReWalk
Intensive training with the ReWalk to negotiate smooth ground, rough terrain indoors and outdoors, ascending and descending slopes and steps, in a home setting and in the community.




Primary Outcome Measures :
  1. Physiological cost index ratio [ Time Frame: 12 weeks from beginning of training and 8 weeks from completing training ]
    Change in heart rate from the average at rest to the average in the last two minutes of the 6 minute walk test is divided by the average speed during the last two minutes of walking. The ration between this measure while wlaking in the Rewalk and the measure while performing the same test using a wheelchair will be calculated. (Walk/wheelchair)


Secondary Outcome Measures :
  1. 10 meter walk test [ Time Frame: 12 weeks from beginning of training and 8 weeks from completing training ]
    Fastest safe walking speed for 10 meters

  2. Max Distance [ Time Frame: 12 weeks from beginning of training ]
    The maximum distance a participant could walk using the Rewalk device within one hour

  3. Limits of stability - sitting [ Time Frame: Baseline, 6 weeks, 12 weeks from beginning of training and 8 weeks from completing training ]
    While sitting/standing on a force plate, the participant will lean in 8 directions guided by a computer screen with feedback of the center of pressure.

  4. Sitting sway [ Time Frame: Baseline, 6 weeks, 12 weeks from beginning of training and 8 weeks from completing training ]
    The participant will sit on a force plate with arms crossed on chest and eyes closed for 30 seconds. The force plate will measure the displacement of the center of pressure

  5. McGill Pain Questionnaire [ Time Frame: Baseline, weekly for 12 weeks, once at 8 weeks from completing training ]
    Paper/pencil questionnaire in which participant selects words that describe current pain. Words are divide into 20 subgroups and ranked within each group. A total score is tabulated by adding the number associated with the highest ranking word from each subgroup. Score range is from 0 to 73 with higher scores indicating greater pain

  6. Spinal Cord Assessment Tool for Spastic reflexes (SCATS) [ Time Frame: Baseline, weekly for 12 weeks, once at 8 weeks from completing training ]
    Response to 3 standardized tests: stretch of ankle plantarflexors, pin prick to the sole of the foot, stretch of the hip and knee flexors

  7. Motor evoked potentials [ Time Frame: Baseline, 6 weeks, 12 weeks from beginning of training ]
    Single pulse transcranial magnetic stimulation over Cz. Responses in paraspinal muscles recorded at 8 levels

  8. Manual Muscle Test [ Time Frame: Baseline, 12 weeks from beginning of training ]
    Standard manual muscle test of lower and upper extremities scored from 0-5



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • traumatic or non-traumatic spinal cord injury ≥1 year post-injury
  • Body height between 5'3" and 6'4"
  • Body weight ≤180 lbs
  • Uses wheelchair as primary mode of mobility
  • If able to walk, walks at ≤0.4 m/s
  • Arm strength sufficient to control forearm crutches
  • Agree to attend intensive training of 1.5 hr/day, 4 days/wk for 14 weeks, plus testing pre and post training of approximately 2 weeks each

Exclusion Criteria:

  • Contractures at the hip, knee or ankle that interferes with fitting into the ReWalk
  • Fractures within the last 2 years
  • Osteoporosis in the legs (t-score ≤-3.0)
  • Severe postural hypotension
  • Severe spasticity that interferes with use of the ReWalk
  • Active pressure sores
  • Pregnancy
  • Severe head injury
  • Conditions that preclude intensive exercise (such as high blood pressure)
  • Presence of conditions contraindicated for transcranial magnetic stimulation

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): NCT02322125


Locations
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Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2G4
Sponsors and Collaborators
University of Alberta
Investigators
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Principal Investigator: Jaynie F Yang, PhD University of Alberta

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT02322125     History of Changes
Other Study ID Numbers: Pro00036789
First Posted: December 22, 2014    Key Record Dates
Last Update Posted: June 19, 2019
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by University of Alberta:
walking
locomotion
rehabilitation
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System