Restoring Walking With a Powered Exoskeleton After Spinal Cord Injury
Restoring Walking With a Powered Exoskeleton After Complete and Sever Incomplete Spinal Cord Injury
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Alberta
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Edmonton, Alberta, Canada, T6G 2G4
- University of Alberta
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Physiological Cost Index (PCI) Ratio
Time Frame: End of training:12-14 weeks from baseline
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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) |
End of training:12-14 weeks from baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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)
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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.
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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)
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Max Distance
Time Frame: End of training:12-14 weeks from baseline
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The maximum distance walked without a rest for up to one hour.
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End of training:12-14 weeks from baseline
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Limits of Stability - Sitting
Time Frame: Baseline, Mid point-6 weeks from baseline, End training:12-14 weeks from baseline
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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.
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Baseline, Mid point-6 weeks from baseline, End training:12-14 weeks from baseline
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Sitting Sway
Time Frame: Baseline, Mid-point:6 weeks from baseline, End training:12-14 weeks from baseline
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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.
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Baseline, Mid-point:6 weeks from baseline, End training:12-14 weeks from baseline
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McGill Pain Questionnaire
Time Frame: Baseline, midpoint:6 weeks from baseline, end training:12-14 weeks from baseline
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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.
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Baseline, midpoint:6 weeks from baseline, end training:12-14 weeks from baseline
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Spinal Cord Assessment Tool for Spastic Reflexes (SCATS)
Time Frame: Baseline, midpoint:6 weeks from baseline, end training:12-14 weeks from baseline
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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
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Baseline, midpoint:6 weeks from baseline, end training:12-14 weeks from baseline
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Motor Evoked Potentials
Time Frame: Baseline, End training:12-14 weeks from baseline
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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
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Baseline, End training:12-14 weeks from baseline
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Change From Baseline in Manual Muscle Test at End of Training
Time Frame: Baseline, end training:12 -14 weeks from baseline
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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
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Baseline, end training:12 -14 weeks from baseline
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jaynie F Yang, PhD, University of Alberta
Publications and helpful links
General 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00036789
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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