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Restoring Walking With a Powered Exoskeleton After Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT02322125
Recruitment Status : Recruiting
First Posted : December 22, 2014
Last Update Posted : November 27, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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
Spinal Cord Injury Device: ReWalk

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 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
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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.


Outcome Measures

Primary Outcome Measures :
  1. Heart rate change from sitting to the end of the 6 minute walk test [ Time Frame: 6 weeks, 12 weeks, 20 weeks from beginning of 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.


Secondary Outcome Measures :
  1. 10 meter walk test [ Time Frame: 6 weeks, 12 weeks, 20 weeks from beginning of training ]
    Fastest safe walking speed for 10 meters

  2. Spinal Cord Injury - Functional Ambulation Profile (SCI-FAP) [ Time Frame: 12 weeks ]
    Time it takes to do 7 specific walking tasks: 5 meters on carpet, 5 meters on smooth ground while carrying a bag with weights, timed-up-and-go, up and down one step, up and down 4 steps, walking while opening a door, walking over and around obstacles

  3. Manual Muscle Test [ Time Frame: 12 weeks from beginning of training ]
    Standard manual muscle test of lower and upper extremities

  4. Spinal Cord Assessment Tool for Spastic reflexes (SCATS) [ Time Frame: 6 weeks, 12 weeks, 20 weeks from beginning of 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

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

  6. Cutaneomuscular reflex threshold and response [ Time Frame: 6 weeks, 12 weeks from beginning of training ]
    Surface electrical stimulation at the posterior tibial nerve (300 Hz, 5 pulses, 0.3 s duration), bilaterally, to determine the threshold for eliciting a response in the tibialis anterior muscle

  7. Sitting and standing balance [ Time Frame: 6 weeks, 12 weeks, 20 weeks from beginning of 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. The participant will also sit/stand as still as possible with eyes closed

  8. McGill Pain Questionnaire [ Time Frame: Weekly, up to 20 weeks from beginning of training ]
    Paper/pencil questionnaire regarding pain experienced over the last week

  9. Structured interview [ Time Frame: 12 weeks from beginning of training ]
    An interview to obtain the participants expectations before the training, and his/her impressions after the training

  10. Patient Health Questionnaire - 9 (PHQ-9) [ Time Frame: Biweekly, up to 20 weeks from beginning of training ]
    Paper/pencil questionnaire with 9 questions


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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
Contacts and Locations

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


Contacts
Contact: Donna Livingstone, BSc 7804922258 donna3@ualberta.ca
Contact: Caitlin Hurd, MSc 7804924858 clhurd@ualberta.ca

Locations
Canada, Alberta
University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 2G4
Contact: Donna Livingstone, BSc    7804922258    carre@ualberta.ca   
Contact: Jaynie Yang, Phd    7804922894    jaynie.yang@ualberta.ca   
Principal Investigator: Jaynie Yang, PhD         
Sub-Investigator: Richard B Stein, PhD         
Sub-Investigator: Monica Gorassini, PhD         
Sub-Investigator: John Misiaszek, PhD         
Sub-Investigator: Francois Roy, PhD         
Sponsors and Collaborators
University of Alberta
Investigators
Principal Investigator: Jaynie F Yang, PhD University of Alberta
More Information

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: November 27, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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