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The purpose of the study is to study the safety and health effects of using the Ekso Bionics powered exoskeleton device in a home setting over a 12-36 month period.
This is a 36 month exploratory Investigational Study compliant with the NSF Human Subjects regulations (45 CFR 690) trialing a new device for the SCI populations to aid in ambulatory function in a home setting. Ekso Bionics will enable up to twelve (12) subjects with SCI to use an Ekso device in their home for a 12-month period. Qualified subjects will help Ekso Bionics determine the practical use of the device in the home environment and will enable Ekso Bionics to gather data to develop a device for use in a home environment. The study will require a trained spotter to be present at all times that the device is being used. The study will also evaluate the effectiveness of a non-medically licensed spotter to assist the subject.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Spinal Cord Injuries
Enrolling by invitation
Published on BioPortfolio: 2015-10-05T09:19:31-0400
The aim of this observational, non-controlled, non-profit study is to describe the responses to rehabilitative training with the robotic exoskeleton EKSO-GT in patients with incomplete mot...
This study is to evaluate the performance attributes and user progression of participants with motor complete and incomplete spinal cord injury (SCI) while utilizing the Ekso robotic exos...
The purpose of this trial is to determine the efficacy of spinal cord stimulation to produce an effective cough in patients with spinal cord injuries.
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Spinal cord injury (SCI) leads to rapid and profound bone loss with large decreases in bone mineral density (BMD) below the level of the lesion. Decreases in BMD of ~2% per month from the ...
To assess the survival and the predictors of mortality in patients with severe cervical spinal cord injuries DESIGN: Retrospective study PARTICIPANTS: From January 1, 2010 to May 31, 2018, 222 patient...
Spinal cord injury (SCI) is a complex chronic condition with multiple self-management requirements and a high prevalence of complications. Pressure injuries (PIs) are among the most common ones and re...
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Virtual and augmented imagery are emerging technologies with potential to reduce the severity and impact of neuropathic pain in people with spinal cord injury (SCI).
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Pathologic conditions which feature SPINAL CORD damage or dysfunction, including disorders involving the meninges and perimeningeal spaces surrounding the spinal cord. Traumatic injuries, vascular diseases, infections, and inflammatory/autoimmune processes may affect the spinal cord.
Penetrating and non-penetrating injuries to the spinal cord resulting from traumatic external forces (e.g., WOUNDS, GUNSHOT; WHIPLASH INJURIES; etc.).
A syndrome associated with damage to the spinal cord above the mid thoracic level (see SPINAL CORD INJURIES) characterized by a marked increase in the sympathetic response to minor stimuli such as bladder or rectal distention. Manifestations include HYPERTENSION; TACHYCARDIA (or reflex bradycardia); FEVER; FLUSHING; and HYPERHIDROSIS. Extreme hypertension may be associated with a STROKE. (From Adams et al., Principles of Neurology, 6th ed, pp538 and 1232; J Spinal Cord Med 1997;20(3):355-60)
Longitudinal cavities in the spinal cord, most often in the cervical region, which may extend for multiple spinal levels. The cavities are lined by dense, gliogenous tissue and may be associated with SPINAL CORD NEOPLASMS; spinal cord traumatic injuries; and vascular malformations. Syringomyelia is marked clinically by pain and PARESTHESIA, muscular atrophy of the hands, and analgesia with thermoanesthesia of the hands and arms, but with the tactile sense preserved (sensory dissociation). Lower extremity spasticity and incontinence may also develop. (From Adams et al., Principles of Neurology, 6th ed, p1269)
Reduced blood flow to the spinal cord which is supplied by the anterior spinal artery and the paired posterior spinal arteries. This condition may be associated with ARTERIOSCLEROSIS, trauma, emboli, diseases of the aorta, and other disorders. Prolonged ischemia may lead to INFARCTION of spinal cord tissue.
Spinal Cord Disorders
The spinal cord is a bundle of nerves that runs down the middle of the back which carry signals back and forth between the body and brain. It is protected by vertebrae, which are the bone disks that make up the spine. An accident that damages the verte...