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Spinal Cord InjuryNCT02322125

Restoring Walking With a Powered Exoskeleton After Spinal Cord Injury

A study testing ReWalk in people with Spinal Cord Injury, run by University of Alberta at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 (SCI). Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Spinal Cord Injury
What is being tested?
ReWalk
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteCanada
Study dates
Jun 2014to 26 Sep 2018
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • Pregnancy
  • Severe head injury
  • Conditions that preclude intensive exercise (such as high blood pressure)
  • Presence of conditions contraindicated for transcranial magnetic stimulation

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • University of Alberta

    Edmonton, Alberta, T6G 2G4

Other trials in Canada

About this study

Official title: Restoring Walking With a Powered Exoskeleton After Complete and Sever Incomplete 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.

Read the 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 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.

Being tested
ReWalk
Keywords
walking, locomotion, rehabilitation
Medical subject headings
Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ReWalkDevice

    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.

Study groups in NCT02322125
Study groupRoleWhat they receive
ReWalk trainingExperimentalReWalk 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.
Receives: Device: ReWalk

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Physiological Cost Index (PCI) Ratio

    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)

    Measured: End of training:12-14 weeks from baseline

Secondary outcomes (8)

  1. 10 Meter Walk Test

    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.

    Measured: 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)

  2. Max Distance

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

    Measured: End of training:12-14 weeks from baseline

  3. Limits of Stability - Sitting

    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.

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

  4. Sitting Sway

    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.

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

  5. McGill Pain Questionnaire

    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.

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

  6. Spinal Cord Assessment Tool for Spastic Reflexes (SCATS)

    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

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

  7. Motor Evoked Potentials

    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

    Measured: Baseline, End training:12-14 weeks from baseline

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

    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

    1. palpable or visible contraction
    2. active movement, gravity eliminated
    3. active movement, against gravity
    4. active movement, against some resistance
    5. active movement, against full resistance

    Measured: Baseline, end training:12 -14 weeks from baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2014 (estimated)
  2. Study startJun 2014
  3. Primary completion20 Aug 2018
  4. Study completion26 Sep 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02322125
Sponsor's protocol ID
Pro00036789
Status last verified
Oct 2021
First submitted
17 Dec 2014
Last updated
14 Oct 2021
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Khan AS, Livingstone DC, Hurd CL, Duchcherer J, Misiaszek JE, Gorassini MA, Manns PJ, Yang JF. Retraining walking over ground in a powered exoskeleton after spinal cord injury: a prospective cohort study to examine functional gains and neuroplasticity. J Neuroeng Rehabil. 2019 Nov 21;16(1):145. doi: 10.1186/s12984-019-0585-x.

    PubMed 31752911

  • Manns PJ, Hurd C, Yang JF. Perspectives of people with spinal cord injury learning to walk using a powered exoskeleton. J Neuroeng Rehabil. 2019 Jul 19;16(1):94. doi: 10.1186/s12984-019-0565-1.

    PubMed 31324256

Questions about this trial

What is this clinical trial studying?

A study testing ReWalk in people with Spinal Cord Injury, run by University of Alberta at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Physiological Cost Index (PCI) Ratio (time frame: End of training:12-14 weeks from baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02322125, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2021.

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