Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, 23249, United States
NCT Number: NCT03410550
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.
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Notify Me18 year–70 year
All sexes
Interventional
Phase 2
Richmond, Virginia, 23249, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
Time frame: 12 weeks
Resting blood pressure and post-exercise blood pressure will be measured every visit.
Time frame: 12 weeks
The robotic unit will measure standing up time, walking time and walking distance for every visit.
Time frame: 12 weeks
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 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
The test will competed at the beginning and at the end of study to measure distance.
Time frame: 12 weeks
The test will competed at the beginning and at the end of study
Time frame: 12 weeks
The test will competed at the beginning and at the end of study
Time frame: 12 weeks
The test will competed at the beginning and at the end of study
Time frame: 12 weeks
The test will competed at the beginning and at the end of study to measure speed.
McGuire Research Institute
Other
Exoskeleton Training After Spinal Cord Injury
Acronym: EXTra-SCI
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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