EKSO Trial: Powered Exoskeleton for Ambulation in Subjects With Spinal Cord Injury (SCI) (EKSO)
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|ClinicalTrials.gov Identifier: NCT01701388|
Recruitment Status : Active, not recruiting
First Posted : October 5, 2012
Last Update Posted : January 6, 2020
This study seeks to test the safety and efficacy of the Esko device in SCI population and in populations with similar neurological weakness to the SCI population. The device can currently stand from a seated position, walk, and turn and sit down. Our hypothesis are as follows:
- Hypothesis 1: We hypothesize that the Ekso subject will significantly improve balance while wearing the device as noted by subject's ability to safely achieve standing balance for 30 sec without loss of balance.
- Hypothesis 2: We hypothesize that the Ekso subject will display improved ability to safely ambulate 10 meters to be assessed using the 10 meter walk test.
- Hypothesis 3: We hypothesize that the Ekso subject will display improved weight shift in both static and dynamic activities as determined by a trained physical therapist.
- Hypothesis 4: We hypothesize that the Ekso subject will verbalize improved success with training of the device as noted by subjective questionnaires that will be assessed following each training session.
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injuries or Similar Neurological Weakness||Device: Ekso exoskeleton||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Investigational Study of the Ekso Powered Exoskeleton for Ambulation in Individuals With Spinal Cord Injury (or Similar Neurological Weakness)|
|Actual Study Start Date :||May 2012|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||September 2020|
Experimental: Ekso Safety and Efficacy
Observational study on the first time use of a robotic exoskeleton.
Device: Ekso exoskeleton
The participants will receive 1 - 40 training sessions. The sessions will be 1 hour of device use including balance training, gait training and sit to and from stand training with rolling walker and/ or forearm crutches.
Other Name: Ekso by Eksobionics
- Change in 6 Minute Walk Test from baseline in distance, rate of perceived exhaustion (RPE), and oxygen uptake [ Time Frame: Testing Day 1 - 3 and follow up testing Week 6 and Week 12. ]The goal is to cover as much ground as possible over 6 minutes, the distance is measured with a measuring wheel. The instructions are "Walk continuously if possible, but do not be concerned if you need to slow down or stop to rest." At the end of 6 minutes the participant is asked to rate their exertion level on a Borg Scale of 6 - 20 points. The maximal oxygen consumption (VO2 MAX) data is collected during the test every 10 seconds
- Change in 10 meter walk test from baseline in gait speed [ Time Frame: Testing Day 1 - 3 and follow up testing Week 6 and Week 12 ]Measure the time in second for and individual to walk 10 meters. The test is performed using a "flying start," patient walks 10 meters (33 ft) and the time is measured when the leading foot crosses the start line and the finish line. The instructions are: " Please walk this distance as fast as you safely can when I say go."
- Ratio of number of steps/walking time [ Time Frame: Testing Day 1 - 3 and follow up testing Week 6 and Week 12. ]The data will be collected from the Ekso statistics mode [data provided by the machine]
- 2 Minute Walk Test [ Time Frame: Testing Day 1 and follow up testing Week 6 and Week 12 ]Individual walks for 2 minutes and the distance is measured, start timing when the individual is instructed to "Go,"stop timing at 2 minutes, assistive devices can be used and documented from test to test, if physical assistance and/or tethering is required it will be recorded as well. The test should be performed at the fastest safest speed possible.
- Walk time to stand time ratio on a particular assistive device [ Time Frame: Testing Day 1 and follow up testing Week 6 and Week 12 ]The data will be collected from the statistics section of the Ekso. As patients progress from a rolling walker assistive device to the forearm crutches the ratio will be collected and compared to the initial and then final sessions with that particular device.
- Psychosocial Impact of Assistive Device Scale (PIADS) [ Time Frame: Day 1- 3 after the first trial of the Ekso, follow up testing on Week 6 and Week 12 ]
The PIADS is a 26-item, self-report questionnaire designed to assess the effects of an assistive device on functional independence, well-being, and quality of life.
The PIADS can be used to assess the impact of any assistive device (AD), prosthesis or medical procedure. It can be used to evaluate the impact of ADs over time and to match the devices with consumers. With its excellent psychometric properties, the PIADS fills a missing link in the assessment of ADs as well as in the examination of their acceptance and abandonment.
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): NCT01701388
|United States, Illinois|
|Rehabilitation Institute of Chicago|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Arun Jayaraman, PhD||RIC/Northwestern|