A Phase 2 interventional study of Exoskeleton Training in Spinal Cord Injuries, sponsored by McGuire Research Institute. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-02-16.
Sponsored by McGuire Research Institute · Phase 2, Interventional, and Treatment
The purpose of the current study is to investigate the effects of powered exoskeleton (EKSO) on cardiovascular performance as measured by resting blood pressure and heart rate, peak oxygen consumption during walking, energy expenditure, whole and regional body composition assessments. The effects of exoskeleton training on walking kinematics including stand-up time, walking time, distance covered and speed of walking will also be evaluated.
Powered exoskeletons using robotic suits have recently been introduced for the rehabilitation of persons with spinal cord injury (SCI). Exoskeletons offer a unique opportunity for persons with SCI to experience standing and walking at a low metabolic cost. Evidence suggested that exoskeleton assisted walking can decrease spasticity and improve bowel movement. Training may also improve the level of physical activity as well as psychological parameters that are likely to interfere with rehabilitation outcomes. Previous studies reported that a frequency of 2-3 times per week or more for 1-2 hours may be beneficial in the rehabilitation of persons with SCI. Using exoskeletal-assisted walking to improve the level of physical activity may be appealing to persons with SCI.
Exoskeleton training for 12 weeks may enhance energy expenditure, parameters of physical activity and result only on modest effects on both cardiovascular and body composition parameters. In other words, persons with tetraplegia may have greater cardiovascular and body composition adaptations compared to persons with paraplegia. Twenty subjects will participate in a powered exoskeleton (EKSO) for one or twice a week for 12 weeks. The program will involve walking with the robotic suits for 1 hour for persons with complete (n=10) and persons with incomplete (n=10) SCI.
Exclusion Criteria:
Twenty men with complete and incomplete SCI will be enrolled in the trial.
Device: Exoskeleton Training
Twenty subjects will participate in a powered exoskeleton (EKSO) for one or twice a week for 12 weeks. The program will involve walking with the robotic suits for 1 hour for persons with complete (n=10) and persons with incomplete (n=10).
Blood Pressure (mmHg)
Resting blood pressure and post-exercise blood pressure will be measured every visit.
Time frame: 12 weeks
Walking time (minutes)
The robotic unit will measure standing up time, walking time and walking distance for every visit.
Time frame: 12 weeks
Oxygen uptake (l/min)
Oxygen uptake will be measured during sitting, standing and walking at the beginning and at the end of the training program.
Time frame: 12 weeks
Body Composition (kg)
Body composition using dual energy x-ray absorptiometry anthropometrics' will be measured during sitting, standing and walking at the beginning and at the end of the training program.
Time frame: 12 weeks
Six minute-walk Test (meter)
The test will competed at the beginning and at the end of study to measure distance.
Time frame: 12 weeks
Walking Index for Spinal Cord Injury II (WISCI II)
The test will competed at the beginning and at the end of study
Time frame: 12 weeks
Electromyography (EMG) activity of 6 muscle groups (mV)
The test will competed at the beginning and at the end of study
Time frame: 12 weeks
Mitochondrial health using near infra-red spectroscopy (seconds)
The test will competed at the beginning and at the end of study
Time frame: 12 weeks
10 meter walk Test (m/sec)
The test will competed at the beginning and at the end of study to measure speed.
Time frame: 12 weeks
Plan to share: No
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
McGuire Research Institute