Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ReWalk training | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | End of training:12-14 weeks from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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) |
| Max Distance |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jaynie F Yang, PhD | University of Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alberta | Edmonton | Alberta | T6G 2G4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31752911 | Background | 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. | |
| 31324256 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Participants were recruited from May 2014 to September 26, 2018. Recruitment was through previous contacts, word of mouth and SCI Alberta newsletter.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All participants who completed mid point tests.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Participants who completed 12 weeks of training intervention | Posted | Mean | Standard Deviation | unit less | End of training:12-14 weeks from baseline |
|
Adverse events were collected from baseline to end of training (12 to 14 weeks from baseline).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin abrasion | Skin and subcutaneous tissue disorders | Systematic Assessment | Abrasion to skin due to friction from device |
Small number of participants suggests data should be interpreted with caution.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jaynie Yang | University of Alberta | 780-492-2894 | jaynie.yang@ualberta.ca |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 5, 2019 | Sep 27, 2021 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The maximum distance walked without a rest for up to one hour. |
| End of training:12-14 weeks from baseline |
| 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. | Baseline, Mid point-6 weeks from baseline, End training:12-14 weeks from baseline |
| 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. | Baseline, Mid-point:6 weeks from baseline, End training:12-14 weeks from baseline |
| 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. | Baseline, midpoint:6 weeks from baseline, end training:12-14 weeks from baseline |
| 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 | Baseline, midpoint:6 weeks from baseline, end training:12-14 weeks from baseline |
| 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 | Baseline, End training:12-14 weeks from baseline |
| 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
| Baseline, end training:12 -14 weeks from baseline |
| 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. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | 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. | All participants who completed >6 weeks of training | Posted | Mean | Standard Deviation | meters/second | 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) |
|
|
|
| Secondary | Max Distance | The maximum distance walked without a rest for up to one hour. | Participants who completed 12 weeks of training | Posted | Mean | Standard Deviation | meters | End of training:12-14 weeks from baseline |
|
|
|
| Secondary | 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. | Participants able to sit unsupported at baseline and 12 weeks of training | Posted | Mean | Standard Deviation | cm | Baseline, Mid point-6 weeks from baseline, End training:12-14 weeks from baseline |
|
|
|
| Secondary | 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. | Participants able to sit unsupported for greater than 22 seconds at baseline and after 12 weeks of training | Posted | Mean | Standard Deviation | cm/s | Baseline, Mid-point:6 weeks from baseline, End training:12-14 weeks from baseline |
|
|
|
| Secondary | 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. | Participants with neuropathic pain at baseline | Posted | Mean | Standard Deviation | score on a scale | Baseline, midpoint:6 weeks from baseline, end training:12-14 weeks from baseline |
|
|
|
| Secondary | 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 | Participants measured weekly for 12 weeks. P1 and P2 were measured only at baseline, 6 weeks and 12 weeks of training. P5 withdrew after 6 weeks of training | Posted | Mean | Standard Deviation | score on a scale | Baseline, midpoint:6 weeks from baseline, end training:12-14 weeks from baseline |
|
|
|
| Secondary | 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 | Participants with adequate background emg | Posted | Mean | Standard Deviation | microvolts | Baseline, End training:12-14 weeks from baseline |
|
|
|
| Secondary | 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
| Participants who completed 12 weeks of training | Posted | Mean | Standard Deviation | units on a scale | Baseline, end training:12 -14 weeks from baseline |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 5 |
| 12 |
|
Not provided
Not provided
Not provided
| D014947 | Wounds and Injuries |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|