Exoskeletal-Assisted Walking in SCI Acute Inpatient Rehabilitation
United States32 participantsStarted 2019-09-30
Plain-language summary
The purpose of this research study is to test the effect of early exoskeletal-assisted walking (EAW) training (combined into regular acute inpatient rehabilitation (AIR)) on improving functional recovery and reducing pain and inflammation. Powered exoskeletons are a technology that offer standing and walking for certain persons with spinal cord injury (SCI) who meet the using indication of the device and have been used in the chronic SCI population with positive benefits in ability to move, daily function (such as bathing and dressing), body composition (such as lean and fat tissue mass), and quality of life (QOL). Despite the potential for EAW to promote functional recovery and reduce secondary medical complications (such as urinary tract infections and pain), no reports exist on the use of exoskeletons in AIR.
Who can participate
Age range
18 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
* Age 18 years or greater
* Height between 5'2" and 6'2" (1.6 meters to 1.9 meters)
* Weight less than 220 pounds (100 kilograms)
* Hip: 5 degrees of extension; 110 of flexion
* Knee: Full extension to 110 of flexion
* Ankle: at least 0 of dorsiflexion to 25 of plantarflexion
* Are eligible for locomotor training as part of inpatient rehabilitation
* Independent with static sitting balance
* Sufficient function upper extremity strength to manage walking aid (front-wheeled walker, platform walker, or crutches)
* Able to follow directions
Exclusion Criteria
* Uncontrolled cardiovascular conditions (i.e. heart failure, angina, hypertension)
* Inability to stand upright due to orthostatic hypotension
* Any form of progressive SCI as defined by the physician, such as cancers
* Body characteristics that do not fit within exoskeleton limits
* Upper leg length discrepancy \> 0.5" or lower leg discrepancy \>0.75"
* Skin integrity issues in areas that would contact the device or that would likely be made worse by device use
* Pregnancy
* Colostomy
* Mechanical ventilation
* Non-English Speaking
* The participant is able to walk better with exoskeleton assistance at baseline
* Any other issue that might prevent safe standing or walking
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 Spinal Cord Independence Measure (SCIM) Version III Scores
Timeframe: Baseline and before discharge from acute inpatient rehabilitation (average 2-3 weeks)