ReStore Exo-Suit Publications Demonstrate Improved Walking Outcomes Versus Conventional Stroke Therapy

 Your stroke hospital should have already evaluated this against these other 92 posts on exoskeletons. But I bet nothing was done and you don't have a functioning stroke hospital! A functioning hospital is up-to-date on all things stroke. If you know about it before they do means PURE INCOMPETENCY!

The latest here:

ReStore Exo-Suit Publications Demonstrate Improved Walking Outcomes Versus Conventional Stroke Therapy

ReWalk Robotics Ltd. (DBA Lifeward)

Randomized clinical trial demonstrates significant improvements in walking ability for patients receiving therapy with the ReStore Exo-Suit as compared to a matched control group receiving conventional stroke therapy.

Additional study demonstrates that the improvements in walking speed and distance following high-intensity gait training with the ReStore Exo-Suit were maintained by individuals post-stroke 4 weeks after the intervention had concluded.

Combined results highlight the clinical value of the ReStore Exo-Suit and its related breakthrough propulsion-augmenting technologies within the Lifeward product development pipeline.

MARLBOROUGH, Mass. and YOKNEAM ILLIT, Israel, March 08, 2024 (GLOBE NEWSWIRE) --  ReWalk Robotics Ltd. (DBA Lifeward™), (Nasdaq: LFWD) (“Lifeward” or the “Company”), a global market leader delivering life-changing solutions to revolutionize what is possible in rehabilitation, recovery, and the pursuit of life’s passions in the face of physical limitation or disability, today highlighted two recent research publications that demonstrate the effectiveness of the unique propulsion training capabilities of the ReStore Exo-Suit for post-stroke rehabilitation.

“We are encouraged by the tremendous clinical value we see in the ReStore Exo-Suit technology and its ability to retrain and augment propulsion for individuals recovering from stroke,” stated Larry Jasinski, CEO at Lifeward. “We believe these recent studies can broaden the use of robotic therapy in the rehabilitation of patients post-stroke and speak to the potential value of the next generation of products for home use in our development pipeline which are based upon the same ReStore technology. We expect that the experience and infrastructure that we have developed for establishing Medicare coverage of the ReWalk Exoskeleton will also facilitate patients’ access to our future technologies. In parallel, we continue to work actively with CMS to determine a final payment amount for the ReWalk Personal Exoskeleton using the current pricing information we submitted in November 2023.”

The most recent publication, from the University of Pécs in Hungary, titled “Investigation of the Effectiveness of the Robotic ReStore Soft Exoskeleton in the Development of Early Mobilization, Walking, and Coordination of Stroke Patients: A Randomized Clinical Trial” examined key walking metrics for two groups of post-stroke patients, randomized to either a conventional therapy program or a program which included training with the ReStore Exo-Suit. The ReStore intervention group demonstrated significant improvements compared to the control group, including a 56% increase in 10-meter walking speed, and a 68% improvement in 6-minute walking distance, and the improved performance was demonstrated to persist at the post-intervention follow up assessment.

A second study from Boston University was presented in an abstract titled “Durable Improvements in Post-Stroke Walking Speed and Distance Following High-Intensity Training with Soft Robotic Exosuits.” This study demonstrated that a 4-week program of intensive gait training with the ReStore Exo-Suit for individuals post-stroke (N=25) resulted in clinically meaningful increases in walking speed (average: 0.17 m/s) and walking distance (34.4 m) which endured a month after the individual had completed the training program. These improvements in speed and distance were accompanied by significant improvements in propulsion mechanics of the paretic limb.

To learn more about the Lifeward mission and product portfolio, please visit GoLifeward.com.

About Lifeward
Lifeward designs, develops, and commercializes life-changing solutions that span the continuum of care in physical rehabilitation and recovery, delivering proven functional and health benefits in clinical settings as well as in the home and community. Our mission at Lifeward is to relentlessly drive innovation to change the lives of individuals with physical limitations or disabilities. We are committed to delivering groundbreaking solutions that empower individuals to do what they love. The Lifeward portfolio features innovative products including the ReWalk Exoskeleton, the AlterG Anti-Gravity systems, the ReStore Exo-Suit, and the MyoCycle FES Systems.

Founded in 2001, Lifeward has operations in the United States, Israel, and Germany. For more information on the Lifeward product portfolio, please visit GoLifeward.com.

ReWalk®, ReStore® and Alter G® are registered trademarks of ReWalk Robotics Ltd. (DBA Lifeward) and/or its affiliates.

The ReWalk ReStore™ soft robotic exosuit: a multi-site clinical trial of the safety, reliability, and feasibility of exosuit-augmented post-stroke gait rehabilitation

The best part of this was the increase in walking in unassisted use after training. Can't tell from this if it prevents ankle rolling.

The ReWalk ReStore™ soft robotic exosuit: a multi-site clinical trial of the safety, reliability, and feasibility of exosuit-augmented post-stroke gait rehabilitation

• Louis N. Awad,
• Alberto Esquenazi,
• Gerard E. Francisco,
• Karen J. Nolan &
• Arun Jayaraman 

Journal of NeuroEngineering and Rehabilitation volume 17, Article number: 80 (2020) Cite this article

• 1 Altmetric
• Metrics details

Abstract

Background

Atypical walking in the months and years after stroke constrain community reintegration and reduce mobility, health, and quality of life. The ReWalk ReStore™ is a soft robotic exosuit designed to assist the propulsion and ground clearance subtasks of post-stroke walking by actively assisting paretic ankle plantarflexion and dorsiflexion. Previous proof-of-concept evaluations of the technology demonstrated improved gait mechanics and energetics and faster and farther walking in users with post-stroke hemiparesis. We sought to determine the safety, reliability, and feasibility of using the ReStore™ during post-stroke rehabilitation.

Methods

A multi-site clinical trial (NCT03499210) was conducted in preparation for an application to the United States Food and Drug Administration (FDA). The study included 44 users with post-stroke hemiparesis who completed up to 5 days of training with the ReStore™ on the treadmill and over ground. In addition to primary and secondary endpoints of safety and device reliability across all training activities, an exploratory evaluation of the effect of multiple exposures to using the device on users’ maximum walking speeds with and without the device was conducted prior to and following the five training visits.

Results

All 44 study participants completed safety and reliability evaluations. Thirty-six study participants completed all five training days. No device-related falls or serious adverse events were reported. A low rate of device malfunctions was reported by clinician-operators. Regardless of their reliance on ancillary assistive devices, after only 5 days of walking practice with the device, study participants increased both their device-assisted (Δ: 0.10 ± 0.03 m/s) and unassisted (Δ: 0.07 ± 0.03 m/s) maximum walking speeds (P’s < 0.05).

Conclusions

When used under the direction of a licensed physical therapist, the ReStore™ soft exosuit is safe and reliable for use during post-stroke gait rehabilitation to provide targeted assistance of both paretic ankle plantarflexion and dorsiflexion during treadmill and overground walking.

Trial registration

NCT03499210. Prospectively registered on March 28, 2018.

Use of the robot assisted gait therapy in rehabilitation of patients with stroke and spinal cord injury

These 11 pages told me nothing useful, NO PROTOCOL. But there is an email address for your doctor to fail to communicate with the researcher so your doctor can stay in the dark about translating research into interventions.   Everyone in stroke talks about what might be helpful, but never delivers on protocols. Survivors are screwed until they are in charge.

Use of the robot assisted gait therapy in rehabilitation of patients with stroke and spinal cord injury

Difficulty in walking is a major feature of neurological disease, and loss of mobility is the activity of daily living on which patients place the greatest value. The impact on patients is enormous, with negative ramifications on their participation in social, vocational, and recreational activities. In current clinical practice the gait restoration with robotic device is an integral part of rehabilitation program. Robot therapy involves the use of a robot exoskeleton device or end-effector device to help the patient retrain motor coordination by performing well-focused and carefully directed repetitive practice. The exoskeleton, as an assistive device, is also an external structural mechanism with joints and links corresponding to those of the human body. These robots use joint trajectories of the entire gait cycle and offer a uniform (more or less) stiff control along this trajectory. In this field the new powered exoskeleton ReWalk (Argo Medical Technologies Ltd) was developed to have an alternative mobility solution to the wheelchair and rehabilitation treatment for individuals with severe walking impairments, enabling them to stand, walk, ascend/descent stairs and more. The end-effector-based robot is a device with footplates placed on a double crank and rocker gear system. Alternatives to powered exoskeletons are devices that use movable footplates to which the patient’s feet are attached. All devices include some form of body weight support. Prominent goals in the field include: developing implementable technologies that can be easily used by patients, therapists, and clinicians; enhancing the efficacy of clinician’s therapies and increasing the ease of activities in the daily lives of patients. Key words: Rehabilitation - Stroke - Spinal cord injuries - Robotics - Orthothic devices.
Corresponding author: P. Sale, IRCCS San Raffaele Pisana, Via della Pisana 235, 00163 Rome, Italy. E-mail: patrizio.sale@gmail.com
 

Marlborough robotics company develops stroke rehabilitation device

Since this is only going to be available in the clinic or hospital, what is the number of hours of use needed to recover proper gait? If that number is not available it hasn't been tested thoroughly.  Or are you willing to let them do a slapstick job and get away with it? 

Marlborough robotics company develops stroke rehabilitation device

MARLBOROUGH - When ReWalks Robotics Inc. began selling its Rewalk exoskeleton device in the United States in 2014, its goal was to help spinal cord injury patients regain use of their legs.
With its newly introduced product, the ReStore Soft Exo-Suit, the Israeli company is looking to upgrade the stroke rehabilitation process for those learning to walk and run again.
The Restore Exo-Suit was officially cleared by the Food and Drug Administration in late June and the company, which has headquarters in Marlborough, has high hopes Restores will begin popping up in clinics throughout the world.
“We want to see it everywhere,” said Andy Dolan, Vice President of Marketing at ReWalk Robotics Inc. “It’s a business goal and a clinical goal to see as many patients to use it as possible.”
The suit is made up of multiple parts.
The Restore’s internals, including its electrical components and gears, is stored in a Waist Pack on a belt worn by the patient. Running down the patient’s lower half are cables that attach to the patient’s legs. Placed on either of the patient’s calves is a removable wrap decked out with a number of force and motion sensors.
Often during therapy, patients are outfitted with restrictive braces that limit their range of movement, according to Kathleen O’Donnell, ReWalk Senior Product, and Clinical Manager.
What sets this product apart from other stroke rehabilitation devices, is that it allows patients to have more dynamic assistance in moving forward and helps them regain movement of their ankles, she said.
Using the included handheld device, clinicians can pick one of three therapy modes, including Assist, Slack and Brace. The application also keeps data of the patient’s gait - the pace and manner in which they walk.

“This allows them to really practice some functional activities,” she said. “They cannot just be good at walking forward on a treadmill in a straight line, but they can really practice maneuvering around objects, starting and stopping and really get to a higher level of function after the recovery.”
In Assist mode, clinicians can directly assist the patient in moving forward. Using the motion sensor placed on the patient’s calf wrap, the app can identify in real time the amount of assistance needed in helping the patient move forward.
Slack Mode, on the other hand, allows for a more hands-off experience that allows the patient to move more freely without much assistance.
Brace Mode tightens and locks in the wrap’s cables to more directly assistance the patient’s movement.
The suit, which starts at around $30,000, won’t be available to purchase by individuals, but instead will be sold directly to clinics.
The company hopes to sell to potentially hundreds of thousands of clinics, given the large number of people that suffer from strokes each year and the product’s competitive price point, Dolan said.
Worldwide more than 15 million people suffer from a stroke each year, according to the World Stroke Organization. And In the United States, more than 795,000 people have a stroke every year, according to the Center for Disease Control and Prevention.

Additionally, more than half of stroke survivors over the age of 65 in the United States suffer from a mobility related issue, the CDC said.
The ReStore didn’t start its life inside the walls of a Rewalk Robotics meeting room or facility, however. It was born out of a project developed out of Harvard University’s Wyss Institute For Biologically Inspired Engineering, according to O’Donnell.
In 2013 a group out of the Institute, which included O’Donnell, started work adapting technology that had been developed by The Defense Advanced Research Projects Agency (DARPA) to help soldiers walking long distances carry large loads.
The Institute wanted to make the technology work in a medical setting, and after meeting with different clinics throughout Boston, the stroke rehabilitation issue presented itself.
“We fundamentally were not in the business of helping people use their ankle again - that wasn’t something clinicians were able to focus on,” she said.
At the same time, ReWalk Robotics was looking to expand its market base, Dolan said.
In 2016, the Institute entered a business agreement with ReWalk to bring the product to market. As part of that deal, O’Donnell moved over from the Institute and now works at ReWalk Robotics full-time.

O’Donnell said that the company sees the ReStore ExoSuit has a platform it plans to develop over time.
“Now that the Wyss team has a solid understanding of all the complexities involved with interfacing with the human body, detecting different types of gait (and) when you should apply assistance and how much you should apply, it’s really exciting to see that there is so much potential,” she said.
Cesareo Contreras writes about environmental issues and technology for the Daily News. He can be reached at 508-626-3957or ccontreras@wickedlocal.com. Follow him on Twitter @cesareo_r.

ReWalk Completes Critical Design Review Processes of Restore System for Move to Clinical Studies

Your stroke hospital should have already evaluated this against these other 92 posts on exoskeletons.

The latest here:

ReWalk Completes Critical Design Review Processes of Restore System for Move to Clinical Studies

MARLBOROUGH, Mass. and YOKNEAM ILIT, Israel, Oct. 16, 2017 /PRNewswire/ -- ReWalk Robotics Ltd. (Nasdaq: RWLK) ("ReWalk") announced today completion of all internal processes to initiate clinical studies and the initial production of its "soft suit" exoskeleton design for stroke patients.  Called "Restore," the new system is the first product in the company's expansion into new technologies that will serve mobility-challenged patient communities.  This design is targeted to serve the stroke rehabilitation community.
This lightweight design of the Restore system was specifically configured for stroke survivors who face mobility issues.  The system is designed to provide real-time adjustable walking assistance for stroke patients in a compact, light, modular soft exosuit structure.  It utilizes some of the key features from structural exoskeleton designs in assisting rehabilitation, with the advancement of being able to achieve these goals without the size, structure and expense of current designs. 
"Achieving successful laboratory testing and design review processes with the Restore system is a milestone that advances our efforts for commercialization," said ReWalk CEO Larry Jasinski.  "The potential of these soft suit designs to expand the utilization of robotic technologies initially with stroke patients in rehab—and in the future for community use—is meaningful. Research into applications, such as multiple sclerosis and Parkinson's Disease is the next horizon."
How It Works: the Restore transmits power to key joints of the legs with cable technologies, powered with software and mechanics that are similar to the technologies used in the ReWalk exoskeleton system for individuals with spinal cord injury. The cables are connected to fabric-based designs that attach to the legs and foot, thus lending the name "soft suit." 
Anticipated delivery of a commercial Restore soft suit is targeted for 2018.   ReWalk plans to commercialize use of the Restore system in Europe and the United States after receiving CE and FDA clearance, respectively, to market the device. The company intends to apply for CE and FDA clearances in mid-2018; CE and FDA clearance applications will be submitted as clinical and laboratory testing are completed in the coming months.
For more information on the Restore soft suit exoskeleton, please visit: www.rewalk.com.
About ReWalk Robotics Ltd.ReWalk Robotics Ltd. develops, manufactures and markets wearable robotic exoskeletons for individuals with spinal cord injury. Our mission is to fundamentally change the quality of life for individuals with lower limb disability through the creation and development of market leading robotic technologies. Founded in 2001, ReWalk has headquarters in the U.S., Israel and Germany. For more information on the ReWalk systems, please visit www.rewalk.com.
ReWalk® is a registered trademark of ReWalk Robotics Ltd. in Israel.

Rewalk Robotics is building a “soft exoskeleton” to rehabilitate stroke patients

Ask your doctor how this compares to these 4 posts on soft exosuit, and these 5 posts on soft robotics.

Your doctor not knowing one damn thing about any of these is worth a call to the hospital president asking why such incompetency is allowed. Not knowing this stuff means your doctor is coasting thru their job rather than keeping up-to-date.

Rewalk Robotics is building a “soft exoskeleton” to rehabilitate stroke patients

I almost guarantee this picture is not a stroke survivor, see shoelaces. I do wonder if a one handed stroke survivor could get this stuff on.

The Boston-based company that was first to provide robotic legs to paralyzed veterans in the U.S., Rewalk Robotics Ltd., has a new product in development that you won’t see this week at CES. The device is a “soft exoskeleton,” designed to help people who have lower limb disability but who have not severed their spinal cord or otherwise become paraplegic.
According to Rewalk CEO Larry Jasinski, “Many people who have had a stroke can stand up but cannot lift their feet well or cannot put their legs down or propel the leg on their own to walk. If you could help them move their legs, but not have to put a big structure around them, it would be a very attractive option.”
The new product will help Rewalk broaden its market, addressing patients recovering from a stroke, or dealing with everything from the effects of old age to diseases that impair their mobility like MS and Parkinson’s disease. The soft exoskeleton could be utilized by these patients, either long-term or as part of a rehab process.
Today, Rewalk’s soft exoskeleton prototype looks more like something a rock climber might wear than Transformer parts. Its main elements are: a belt and fanny pack with motors and a computer within, cables that extend down the legs, knee braces to keep them in place and sensor-laden footplates that can fit into a sneaker or other soft shoe.
The waist belt weighs about eight pounds and the cables, braces and footplates add about two more pounds to the total weight, at this point. Rewalk acquired the initial technology design from the Wyss Institute at Harvard, which had begun developing a “biologically inspired smart suit,” the Medexo, with funding from the U.S. Defense Advanced Research Projects Agency (DARPA) back in 2014. DARPA has long had an interest in technology that can be applied to help soldiers or medics walk farther, or for longer, and carry more weight in the field.
Jasinski tells TechCrunch that one reason for the tech transfer deal was that Harvard researchers had a great design, but needed to marry it with expertise around motors, gears and software to make it work in the real world. Rewalk had done all that with its earlier systems, and had also figured out how to work with the FDA and the VA to get its devices approved for veteran benefits reimbursements.
Here’s how the new technology helps a patient to walk on their own, Jasinski explained: “Think about a bicycle. You have cables that transfer force down a line to close a brake down on the bike’s tires. This uses the same principal but is obviously more complex. One cable runs along the outside part on the front of your leg and another on the back. The motor and gear are on your waist attached to the cables. A lightweight brace worn on your calf keeps the cables in place. The computer and our software will tell the motor to turn just enough to lift the cable, pull it and get you ground clearance, then propel your foot forward. Sensors in a footplate in your shoe send data to the computer to let it know everything about your position and when you are walking.”
Rewalk will begin clinical studies of its soft exoskeletons in the back half of 2017. The company seeks to make the device available in 2018, pending FDA approvals. The soft exoskeleton will initially have power sufficient to move the legs, or be constantly walking, for two hours at a stretch.
The company will seek distribution again through the VA health system and private sector rehab centers that already pay for “gait training” systems for stroke patients. Later, the product could be adapted for those with diseases like MS, which strikes more women than men and usually is diagnosed in a person’s late 20s or early 30s, or Parkinson’s.
“If you had a stroke, and you were laying in a hospital bed for 10 days, theoretically you could lose 10% to 20% of your muscle mass,” Jasinski said. If you could use this in recovery, you’d have a much better chance at regaining your mobility in full is the hope. With MS and Parkinson’s we think about using this to walk more, and put off later-stage developments.”
Featured Image: rewalk.com

ReWalk Exoskeleton Must be Covered by Insurer, Says Medical Review Organization

Our fucking failures of stroke associations should be following up with all the other exoskeletons out there and making sure they are covered. That is a joke since it will NEVER occur.
These 67 exoskeleton posts. These 354 walking posts.
Your doctor can correlate the intersection of these posts, I'm not being paid for this, they are.

ReWalk Exoskeleton Must be Covered by Insurer, Says Medical Review Organization

This week, ReWalk Robotics Ltd., a company that designs exoskeletons for use by paraplegics, announced that an independent medical review organization ruled that a U.S. health insurance provider is responsible for reimbursing a patient for a ReWalk Personal exoskeleton system.
The news comes after the health insurance provider initially denied the patient coverage.
While official details are scant from ReWalk, the company did mention that the beneficiary is a surgeon, who, after suffering a spinal cord injury, makes use of a wheelchair 11 hrs per day.
“The ruling by the independent medical organization marks an important moment for exoskeletons being accepted as protocol technology for those with spinal cord injury,” said ReWalk’s CEO Larry Jasinksi. “Health benefit providers have historically been hesitant to acknowledge the clinical benefits in their case assessments. This ruling, and subsequent coverage and reimbursement will help ReWalk in our efforts to facilitate greater patient access to the device.”
According to Motherboard, the ReWalk costs $69,500. The device was approved for marketing by the U.S. Food and Drug Administration (FDA) in June 2014. At the time, the Centers for Disease Control and Prevention estimated that around 200,000 people suffered from spinal cord injury in the U.S.
The ReWalk isn’t the only exoskeleton recently receiving media attention. The company SuitX recently unveiled their model for the Phoenix, which costs around $40,000. The research behind the device was funded by the Defense Advanced Research Projects Agency (DARPA).
However, ReWalk has stated that its model is the only exoskeleton currently approved for market by the FDA. Under the approval, it can be used in rehabilitation and personal settings.
According to ReWalk, the Personal model is capable of walking speeds up to 1.6 mph, helps improve bowel and bladder function, and decreases body fat and pain, among other things.
In December 2015, the U.S. Dept. of Veteran Affairs set a national policy, and agreed to pay for ReWalk exoskeletons for eligible veterans with spinal cord injuries.

 

Woman in Bionic Suit Runs Marathon

A real life use of ReWalk. So ask your doctor when their clinic will have this or these other possibilities.
Woman in Bionic Suit Runs Marathon

Bionic suit allows Vietnam vet to walk again

Is this better than Cyberdyne Hal from Japan? Your doctor better know the answer.

Bionic suit allows Vietnam vet to walk again