Back to resultsRestoring Walking With a Powered Exoskeleton After Spinal Cord Injury
Primary Purpose
Spinal Cord Injury
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
ReWalk
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injury focused on measuring walking, locomotion, rehabilitation
Eligibility Criteria
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
Sites / Locations
- University of Alberta
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ReWalk training
Arm Description
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.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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.
Max Distance
The maximum distance walked without a rest for up to one hour.
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.
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.
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.
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
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
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
palpable or visible contraction
active movement, gravity eliminated
active movement, against gravity
active movement, against some resistance
active movement, against full resistance
Full Information
NCT ID
NCT02322125
First Posted
December 17, 2014
Last Updated
October 13, 2021
Sponsor
University of Alberta
1. Study Identification
Unique Protocol Identification Number
NCT02322125
Brief Title
Restoring Walking With a Powered Exoskeleton After Spinal Cord Injury
Official Title
Restoring Walking With a Powered Exoskeleton After Complete and Sever Incomplete Spinal Cord Injury
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
August 20, 2018 (Actual)
Study Completion Date
September 26, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. 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 (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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
Keywords
walking, locomotion, rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ReWalk training
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
ReWalk
Intervention Description
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 Measure Information:
Title
Physiological Cost Index (PCI) Ratio
Description
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)
Time Frame
End of training:12-14 weeks from baseline
Secondary Outcome Measure Information:
Title
10 Meter Walk Test
Description
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.
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)
Title
Max Distance
Description
The maximum distance walked without a rest for up to one hour.
Time Frame
End of training:12-14 weeks from baseline
Title
Limits of Stability - Sitting
Description
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.
Time Frame
Baseline, Mid point-6 weeks from baseline, End training:12-14 weeks from baseline
Title
Sitting Sway
Description
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.
Time Frame
Baseline, Mid-point:6 weeks from baseline, End training:12-14 weeks from baseline
Title
McGill Pain Questionnaire
Description
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.
Time Frame
Baseline, midpoint:6 weeks from baseline, end training:12-14 weeks from baseline
Title
Spinal Cord Assessment Tool for Spastic Reflexes (SCATS)
Description
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
Time Frame
Baseline, midpoint:6 weeks from baseline, end training:12-14 weeks from baseline
Title
Motor Evoked Potentials
Description
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
Time Frame
Baseline, End training:12-14 weeks from baseline
Title
Change From Baseline in Manual Muscle Test at End of Training
Description
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
Time Frame
Baseline, end training:12 -14 weeks from baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaynie F Yang, PhD
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2G4
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31752911
Citation
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.
Results Reference
background
PubMed Identifier
31324256
Citation
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.
Results Reference
derived
Learn more about this trial
Restoring Walking With a Powered Exoskeleton After Spinal Cord Injury
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