Restoring Walking With a Powered Exoskeleton After Spinal Cord Injury
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02322125|
Recruitment Status : Active, not recruiting
First Posted : December 22, 2014
Last Update Posted : May 30, 2018
|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|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||October 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.
- Heart rate change from sitting to the end of the 6 minute walk test [ Time Frame: 6 weeks, 12 weeks, 20 weeks from beginning of 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.
- 10 meter walk test [ Time Frame: 6 weeks, 12 weeks, 20 weeks from beginning of training ]Fastest safe walking speed for 10 meters
- Spinal Cord Injury - Functional Ambulation Profile (SCI-FAP) [ Time Frame: 12 weeks ]Time it takes to do 7 specific walking tasks: 5 meters on carpet, 5 meters on smooth ground while carrying a bag with weights, timed-up-and-go, up and down one step, up and down 4 steps, walking while opening a door, walking over and around obstacles
- Manual Muscle Test [ Time Frame: 12 weeks from beginning of training ]Standard manual muscle test of lower and upper extremities
- Spinal Cord Assessment Tool for Spastic reflexes (SCATS) [ Time Frame: 6 weeks, 12 weeks, 20 weeks from beginning of 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: 6 weeks, 12 weeks from beginning of training ]Single pulse transcranial magnetic stimulation over Cz. Responses in paraspinal muscles recorded at 8 levels
- Cutaneomuscular reflex threshold and response [ Time Frame: 6 weeks, 12 weeks from beginning of training ]Surface electrical stimulation at the posterior tibial nerve (300 Hz, 5 pulses, 0.3 s duration), bilaterally, to determine the threshold for eliciting a response in the tibialis anterior muscle
- Sitting and standing balance [ Time Frame: 6 weeks, 12 weeks, 20 weeks from beginning of 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. The participant will also sit/stand as still as possible with eyes closed
- McGill Pain Questionnaire [ Time Frame: Weekly, up to 20 weeks from beginning of training ]Paper/pencil questionnaire regarding pain experienced over the last week
- Structured interview [ Time Frame: 12 weeks from beginning of training ]An interview to obtain the participants expectations before the training, and his/her impressions after the training
- Patient Health Questionnaire - 9 (PHQ-9) [ Time Frame: Biweekly, up to 20 weeks from beginning of training ]Paper/pencil questionnaire with 9 questions
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|