Restoring Walking With a Powered Exoskeleton After Spinal Cord Injury
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|ClinicalTrials.gov Identifier: NCT02322125|
Recruitment Status : Completed
First Posted : December 22, 2014
Last Update Posted : June 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injury||Device: ReWalk||Not Applicable|
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 SCI. 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 SCI.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Restoring Walking With a Powered Exoskeleton After Spinal Cord Injury|
|Study Start Date :||June 2014|
|Actual Primary Completion Date :||July 30, 2018|
|Actual Study Completion Date :||September 26, 2018|
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.
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.
- Physiological cost index ratio [ Time Frame: 12 weeks from beginning of training and 8 weeks from completing training ]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. The ration between this measure while wlaking in the Rewalk and the measure while performing the same test using a wheelchair will be calculated. (Walk/wheelchair)
- 10 meter walk test [ Time Frame: 12 weeks from beginning of training and 8 weeks from completing training ]Fastest safe walking speed for 10 meters
- Max Distance [ Time Frame: 12 weeks from beginning of training ]The maximum distance a participant could walk using the Rewalk device within one hour
- Limits of stability - sitting [ Time Frame: Baseline, 6 weeks, 12 weeks from beginning of training and 8 weeks from completing training ]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.
- Sitting sway [ Time Frame: Baseline, 6 weeks, 12 weeks from beginning of training and 8 weeks from completing training ]The participant will sit on a force plate with arms crossed on chest and eyes closed for 30 seconds. The force plate will measure the displacement of the center of pressure
- McGill Pain Questionnaire [ Time Frame: Baseline, weekly for 12 weeks, once at 8 weeks from completing training ]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) [ Time Frame: Baseline, weekly for 12 weeks, once at 8 weeks from completing training ]Response to 3 standardized tests: stretch of ankle plantarflexors, pin prick to the sole of the foot, stretch of the hip and knee flexors
- Motor evoked potentials [ Time Frame: Baseline, 6 weeks, 12 weeks from beginning of training ]Single pulse transcranial magnetic stimulation over Cz. Responses in paraspinal muscles recorded at 8 levels
- Manual Muscle Test [ Time Frame: Baseline, 12 weeks from beginning of training ]Standard manual muscle test of lower and upper extremities scored from 0-5
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02322125
|University of Alberta|
|Edmonton, Alberta, Canada, T6G 2G4|
|Principal Investigator:||Jaynie F Yang, PhD||University of Alberta|