What is Ekso GT™?
Ekso GT™ is a robotic exoskeleton used by therapists in rehabilitation settings to help individuals with any amount of lower extremity weakness to stand up and walk, either with the help of the device or as a tool to help them to learn to walk again on their own. Walking is achieved by the user’s weight shifts or the push of a button to activate sensors in the device which initiate the steps. Battery-powered motors drive the legs, replacing deficient neuromuscular function.
Who is it for?
The Ekso robotic exoskeleton is for patients with lower-extremity weakness, paralysis or hemiparesis due neurological disease or injury such as stroke, spinal cord injuries, Multiple Sclerosis, Guilain Barre Syndrome. The user needs sufficient upper extremity strength to balance with crutches or a walker, and must also be between 5'2" - 6'2" (150-190 cm) tall, weigh no more than 220 lbs (100 kg), and have hips no wider than 18". Sufficient trunk, upper extremity, or lower extremity strength to provide balance and forward momentum for proper ambulation and manage an assistive device. Ability to manage weight transfers and sitting balance. Ability to follow basic instructions and to communicate in some manner understood to the operator if they are in distress or pain. Ability to support majority of body weight on arms.
How do you know if you are eligible to use an Ekso robotic exoskeleton?
Interested parties should first contact their nearest Ekso Center at www.eksobionics.com. In order to be eligible to walk in an Ekso suit, the patient needs to first obtain a medical release from their physician. Then, a comprehensive physical evaluation is conducted by an Ekso Certified Physical therapist, which typically takes one hour. During this evaluation, the therapist examines key requirements for use including range of motion, muscle strength and spasticity and autonomic dysflexia, sufficient cognitive ability, ability to communicate, standing tolerance and spinal stability.
How is it used?
An Ekso suit provides rehabilitation, over ground gait training, and upright, weight bearing exercise under the supervision of a trained physical therapist. The suit is strapped over the users´ clothing with easy adjustments to transition between patients in as little as five minutes. Today, the Ekso robotic exoskeleton is used primarily in a clinic or rehabilitation setting under the supervision of a physical therapist. We also have a number of individuals in the US and Europe who own and are using their own Ekso suits daily for their personal rehab and wellness programs with great success… either with private therapists, or in some cases, under an IRB study with a trained lay spotter.
Are there multiple indications for use?
1. For people with some motor ability intact, the Ekso suit helps patients re-learn proper step patterns and weight shifts using a task-based platform which many clinicians believe may important for people who have the potential to re-learn to walk again; for example after a stroke or an incomplete spinal cord injury.
2. For people with complete lower extremity paralysis from a spinal cord injury, the Ekso suit gets them up and walking; there are anecdotal reports from users that they experience a reduction in secondary complications resulting from life in a wheelchair; such as depression, neuropathic pain, bowel and bladder complications, and so forth. There are clinical studies underway to further explore these reports - see next question.
What evidence is there for this device?
There is a rapidly growing body of evidence that the Ekso robotic exoskeleton may safely help to reduce neuropathic pain, spasticity, and improve quality of life with no adverse events. For a more complete overview please see our Clinical Research Summary. If you would like to become part of our group of centers conducting research or participate as an individual in our IRB study please contact email@example.com
What makes Ekso GT robotic exoskeleton an ideal tool for gait training?
Everyone walks in first session, the learning curve is quite user specific and can depend on many factors. Usually, individuals begin using a walker and progress to crutches.
Provides 0-100% assist to either leg (variable assist) based on both device assessment of patient need and therapist input (adaptive assist). -Stepping requires lateral & forward weight shift (and optional user initiation) putting the user in control of stepping and stopping.
Highest injury level inclusion, complete SCI, incomplete SCI, Stroke and other neurological conditions
Provides therapist with real time, in session performance data and ability to adjust gait parameters via handheld device as well as internal online remote connection to factory for performance diagnostics and troubleshooting. (Pulse)
No skin issues - complete soft goods kit to enable user comfort and safety, allowing a more customized fit, allows users to use own shoes. --In and out of suit in 5 minutes, two sets of rechargeable batteries for continued use.
The device weighs 50 pounds (23 kg) but the user doesn’t support the weight of the device as it is transferred into the ground through the exoskeleton
When will this suit be available as a personal mobility device?
Ekso Bionics remains focused on the clinical and rehab markets, with the belief that this is the most valuable application for the technology today, as well as being a critical path to developing a viable consumer application, when the time and technology is appropriate, for personal mobility in the community.
Why is Ekso GT™ robotic exoskeleton considered a Class I Medical device?
Our robotic exoskeleton is deemed low risk because it's intended to be used in a medical facility under the supervision of a physical therapist.
What do the different FDA classification levels mean?
FDA classifies medical devices based on the risks associated with the device. Devices are classified into one of three categories—Class I, Class II, and Class III.
1. Class I devices are deemed to be low risk and are therefore subject to the least regulatory controls. For example, dental floss is classified as Class I device.
2. Class II devices are higher risk devices than Class I and require greater regulatory controls to provide reasonable assurance of the device’s safety and effectiveness. For example, X-ray machines, infusion pumps, surgical drapes/needles are classified as Class II devices.
3. Class III devices are generally the highest risk devices and are therefore subject to the highest level of regulatory control. Class III devices must typically be approved by FDA before they are marketed. For example, replacement heart valves are classified as Class III devices.
4. "De Novo " Devices of a new type that FDA has not previously classified based on risk are “automatically” or “statutorily” classified into class III by operation of section 513(f)(1) of the FD&C Act, regardless of the level of risk they pose. This is because, by definition, a new type of device would not be within a type that was on the market before the 1976 Medical Device Amendments or that has since been classified into class I or class II.