EKSO Trial: Powered Exoskeleton for Ambulation in Subjects With Spinal Cord Injury (SCI) (NCT01701388) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
EKSO Trial: Powered Exoskeleton for Ambulation in Subjects With Spinal Cord Injury (SCI)
United States40 participantsStarted 2012-05
Plain-language summary
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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Participants must:
* have a spinal cord injury SCI between C7-S1.
* be between 18-65 years of age.
* be able to physically fit into the exoskeletal device.
* be able to tolerate upright standing for a minimum of 30 minutes.
* have joint range of motion (ROM) within normal functional limits for ambulation.
* have sufficient upper body strength to balance themselves using the walker while wearing the exoskeleton.
* have a different neurological weakness than SCI but fit the other inclusion criteria above
Exclusion Criteria:
* Height below 62 inches or above 74 inches
* Weight above 220 lbs.
* Joint contractures of any extremity that limits normal ROM during ambulation with assistive devices.
* Any medical issue that precludes full weight bearing and ambulation (e.g. orthopedic injuries, pain, severe spasticity)
* Skin issues that would prevent wearing the device.
* Cognitive and/or communicative disability (e.g. due to brain injury). Patients must be able to follow directions well and demonstrate learning capability.
* Significant Osteoporosis: Osteoporosis will be graded based on the T score that indicates a person's bone mineral content and is graded as follows: (14)
T +1: Normal bone density:
* T -1 to -2.5: Low bone density of osteopenia
* T -2.5 to -3.0: osteoporosis
* T \<-3.0: Severe osteoporosis
* If the patient has severe osteoporosis and a T score of \<-3, participation in the study will be considered based upon their physicians recommendatio…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in 6 Minute Walk Test from baseline in distance, rate of perceived exhaustion (RPE), and oxygen uptake
Timeframe: Testing Day 1 - 3 and follow up testing Week 6 and Week 12.
2
Change in 10 meter walk test from baseline in gait speed
Timeframe: Testing Day 1 - 3 and follow up testing Week 6 and Week 12