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Completed

NCT Number: NCT02322125

Restoring Walking With a Powered Exoskeleton After Spinal Cord Injury

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 (SCI). 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.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alberta

Edmonton, Alberta, T6G 2G4, Canada

About this study

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 spinal cord injury. 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 spinal cord injury.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • non-progressive spinal cord injury ≥1 year post-injury
  • Body height between 5'3" and 6'4"
  • Body weight ≤82 kg
  • 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

Treatment and study plan

ReWalk

Device

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 outcomes

  1. Physiological Cost Index (PCI) Ratio

    Time frame: End of training:12-14 weeks from baseline

    PCI is defined as the 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 to give a measure of heartbeats/minute.

    The ratio between this measure while walking in the Rewalk and the same measure while performing the test using a wheelchair will be calculated. (Walk/wheelchair)

Secondary outcomes

  1. 10 Meter Walk Test

    Time frame: End of training (at 12 weeks for 10 participants and 6 weeks for 1) and at follow-up (2-3 months from end of training)

    Walking is timed over a 10 m section while the participant walks in the ReWalk in a 40 m hallway at the fastest safe speed possible.

  2. Max Distance

    Time frame: End of training:12-14 weeks from baseline

    The maximum distance walked without a rest for up to one hour.

  3. Limits of Stability - Sitting

    Time frame: Baseline, Mid point-6 weeks from baseline, End training:12-14 weeks from baseline

    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 sum of the maximum fore-aft and left right excursions was calculated. The changes from baseline to mid point of training, the end of the training phase (12 weeks) were calculated.

  4. Sitting Sway

    Time frame: Baseline, Mid-point:6 weeks from baseline, End training:12-14 weeks from baseline

    Participants will sit on a force plate with feet unsupported, arms crossed over the chest and eyes closed. The trajectory of the center of pressure is measured for a maximum of 30 seconds or until balance is lost.

  5. McGill Pain Questionnaire

    Time frame: Baseline, midpoint:6 weeks from baseline, end training:12-14 weeks from baseline

    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, midpoint:6 weeks from baseline, end training:12-14 weeks from baseline

    Response to 3 standardized tests: stretch of ankle plantarflexors, pin prick to the sole of the foot, stretch of the hip and knee flexors scored from 1 to 3. The scores form both lower extremities were summed (total score: no spasticity = 0; maximum spasticity = 36

  7. Motor Evoked Potentials

    Time frame: Baseline, End training:12-14 weeks from baseline

    Single pulse transcranial magnetic stimulation is delivered over the vertex to induce motor evoked potentials in the back extensor muscles. Electrical responses in paraspinal muscles were recorded at 8 levels spanning the injury. The peak to peak amplitude of the response was averaged over rials with background muscle contraction of 10 to 40 microvolts

  8. Change From Baseline in Manual Muscle Test at End of Training

    Time frame: Baseline, end training:12 -14 weeks from baseline

    Five muscle groups in each lower extremity (hip flexors, knee extensors, ankle dorsiflexors, extensor of the big toe, and ankle plantarflexors) were tested as per the American Spinal Injury Association Impairment scale. Each muscle group was scored on a scale ranging from 0-5, where 0/5 indicates no muscle activity and is the lowest score and is considered to be a worse outcome. A score of 5/5 indicates normal strength and is considered the better outcome. The scores for all 10 muscle groups were summed so that the maximum score is 50. Change from baseline in Manual Muscle Test to end of training was calculated.

    0= total paralysis

    • palpable or visible contraction
    • active movement, gravity eliminated
    • active movement, against gravity
    • active movement, against some resistance
    • active movement, against full resistance

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Official study title

Restoring Walking With a Powered Exoskeleton After Complete and Sever Incomplete Spinal Cord Injury

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Dec 22, 2014
Registry last updated
Oct 14, 2021

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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