Over 3.3 percent of all Americans live with the consequences of stroke, which often seriously impairs motor and cognitive skills. Many experts agree that the most important element in any rehabilitation program is carefully directed, well-focused, repetitive practice. Studies show virtual reality (VR) could be a valuable tool to help rewire neural pathways, but no one has productized a hardware/software solution tailored to the needs of rehab patients with a low-cost/at-scale product until the REAL Immersive System.
REAL is a simple, portable rehabilitation tool that can be used at the patient's bedside, in a therapy gym, or a mobile health location. It's an immersive VR and display system that tracks upper extremity rehabilitation exercises for adults who have symptoms related to stroke or neurodegenerative diseases. It is the first VR system that is purpose-built from the ground up for rehabilitation in a healthcare environment.
REAL uses multiple body sensors and a unique headset designed specifically for patients with limited strength and mobility. To make rehab fun, the immersive activities employ all the tricks of game design to engage the patient and keep them motivated. Because the system is wireless, the therapist can help with a patient's movement and the patient will see their avatar moving like it is their own body, which encourages development of new neural pathways.
REAL was designed by engineers and designers with decades of experience in electronics, medical device design, software development, 3D art, and game development. Evidence-based, effective therapies utilized by clinical rehabilitation experts were used to build therapy experiences within REAL.
The system is radically different from other rehab technologies because of its versatility and mobility. Its components include a VR headset, six sensors, and a tablet with an app that allows the clinician to administer and monitor the therapy session. Upon powering on, the patient is immediately immersed in VR, engaging in visual challenges guided by their therapist. Highly accurate electromagnetic sensors are used rather than the typical optical sensors, which require "line of sight" tracking. Electromagnetic tracking allows the therapist to be wherever they need to be around their patient without disrupting position tracking, creating a more stable and consistent user experience. The sensors are attached with soft neoprene bands, and in less than two minutes of set-up, the patient is working in a virtual world with their full-presence avatar.
The headset is light and comfortable, and the sensors and their attachment straps were designed expressly for patients with limited grip strength and mobility. The Happy Valley environment was designed to engage and empower older adults.
Therapists can see what the patient sees on the tablet, which they use to select various activities, adjust activity parameters, and monitor the patient's experience. Data from the patient's movement is securely saved for easy documentation, and long-term trending can guide the patient's recovery.
The US spends an estimated $34 billion per year on stroke treatment, rehabilitation, and lost productivity. In addition to more effective preventative and acute stroke care, the AHA/ASA cites the need for more effective rehabilitative services.
Patients who engage in rehabilitation with more intensity and frequency over longer time periods tend to have better outcomes. However, the CDC reports that less than a third of discharged stroke patients receive any rehab, and of those who do, frequency of use is low despite clear evidence that it's effective. There are numerous possible reasons for this. Stroke rehab needs to be performed intensively, repeatedly, and for up to a year to be most effective. Following a stroke, patients are often depressed, cognitively impaired, and unmotivated due to their new disability. Feedback mechanisms to help the patient relearn correct movement patterns are labor intensive and lack stimulation. Despite these barriers, extensive research shows that neurorehabilitation technology can dramatically enhance neuroplasticity and drive the relearning of skills impacted by damage from stroke, better than conventional therapy alone.
With VR, the rehabilitation environment can be safe, encouraging, efficient, and supportive. "Addictive" qualities of gaming can encourage compliance with a rehab plan—one of the largest barriers to successful recovery.
The inspiration for the REAL system came from a mutual friend of the presidents of Penumbra, a company specializing in solutions in the neuro and vascular interventional space, and Sixense, a company specializing in enterprise use of VR hardware and software. Their friend's wife, Deb, experienced a stroke and was coming into Sixense's offices to play VR games with her therapist. Watching her joy at interacting in this virtual environment, the companies saw the opportunity to create a life-changing technology for people recovering from strokes. Given Penumbra's extensive experience in the stroke space, joining forces with Sixense on the project was a natural partnership. Deb remained the development team's muse throughout the development process.
Neither company had experience providing solutions in the rehab environment. That's where Delve, a consultancy with extensive medical device design experience, came into the picture. Delve's engineers and designers went into the field to interview and observe physical therapists to understand their needs. Their goal was to help adapt Sixense's immersive VR technology to work in a variety of rehab settings.
Physical therapists typically work in hourlong sessions with their patients. Therapy sessions can happen in the rehab gym, at the bedside or a mobile health location. As we interviewed therapists, the team learned how important it is to be able to set up quickly in a variety of settings to maximize time with the patient, customize the experience to each patient's therapy plan, and allow for the therapist to be in physical contact with the patient throughout the session. As is the case for all medical equipment, the ability to wipe it down and keep vulnerable patients protected from infection was paramount.
Because the underlying technology to be used was undetermined at the start of the development process, Delve's engineers and designers worked in tandem. Engineers collaborated with Sixense to understand the electronic requirements for the sensors and headset, working to minimize size and weight. Designers created concepts for both the components and a means for therapists to comfortably but securely attach sensors to patients.
The overriding goal was to create a system that wouldn't force either the therapist or patient to do anything that felt unnatural. The team repeatedly placed prototypes in front of therapists to get feedback that guided development throughout the process.
There were many technical requirements to be addressed. Tracking sensors required placement of a sensing coil and battery inside a compact package that attaches to the body in an ergonomic, comfortable fashion. The organic form of the sensors was created to mimic the curves of the human body with a little valley in the center to hold the band securely and provide necessary separation of the components. Sensors are attached with soft neoprene bands designed to be easy for the therapist to place on the patient. The bands come in a set that is assigned to the patient for the duration of therapy to limit infection risk.
The headset was engineered from existing technology, which limited the amount of customization. The team focused on achieving balanced weight distribution around the head, making it more comfortable.
About 75 percent of stroke rehab patients are over age 65 and many are unfamiliar with VR technology, so minimizing the intimidation factor through design was important. Components were designed to look small, easy to grip, sleek, and integrated. The dark gray lower half reduces visual mass and the white upper half provides modern, clean design. There are no buttons, switches or physical lights. Once the sensors are strapped on, the patient can focus on interacting with the virtual world through upper body movement with the assistance of the therapist.
The final product, the REAL Immersive System addresses all the unique challenges of delivering VR physical therapy in a healthcare setting:
· It's robust enough to work in environments, particularly gyms, that include metal equipment that can interfere with a signal.
· The headset and sensors are completely untethered, making it easy to interact with the patient and deliver therapy in a variety of settings.
· Setup takes about two minutes and the whole system recharges in its carrying case within an hour.
· Unlike most VR systems that use optical sensors, which require "line of sight" tracking, REAL uses highly accurate electromagnetic sensors. Electromagnetic tracking allows the therapist to be wherever they need to be around their patient without disrupting position tracking, creating a more stable and consistent user experience.
· Sensors were designed to accommodate limited grip strength and mobility.
· Soft neoprene straps for sensors are covered by insurance as a separate item, which is helpful to healthcare providers for billing. Each patient gets their own set for the duration of therapy, which supports infection control.
· The system includes a tablet with the TherapyView app. Therapists can see what the patient sees on the tablet, which they use to select various activities, adjust activity parameters, and monitor the patient's experience.
· Data from the patient's movement during a session is securely saved for easy documentation, and long-term trending can guide the patient's recovery.
· Penumbra put an emphasis on making this technology affordable. A $1,340 monthly subscription serves multiple patients and includes training and support.
Most importantly, The REAL Immersive System makes therapy sessions fun. Any type of physical rehabilitation is difficult. That's especially true when recovering from a brain injury. Progress is typically slow and it's easy to become discouraged and depressed. REAL uses all the tricks of game design to engage the patient and keep them motivated. There are awards for achievement, progression among levels, and the Happy Valley environment is designed to tap into the basic human need to help someone else.
Patients will often quit therapy out of frustration because it's boring and they don't see progress. In Happy Valley, the patient is in control. They help vegetables grow, puts birds in nests, build houses – immersed in a world where they can see their avatar (which the brain processes as an extension of the body) making a difference. Progress still takes time and repetition, but the data collected from the sessions enables therapists to show patients their steady progress, helping them to stay motivated.
Here's real-life example from a developer of the REAL system:
"I went to get feedback from a patient. She was four months out from a stroke – in her late 40s with a child at home. She was reliant on her 70-year-old mother to get to appointments. Her left arm had almost no motor control. She seemed depressed. When she put on the system and I lifted her arm for her, she broke down sobbing. She couldn't see me in this environment, but she could 'see' her arm working normally. It gave her hope."
Penumbra believes VR rehabilitation has broader application for a variety of condition beyond stroke and brain injury. While it launched REAL in institutions, the company intends to derivatize the system for home use. With the availability of low-cost, mobile VR therapy, effective rehabilitation can become accessible to more patients. With VR, the rehabilitation environment can be safe, encouraging, efficient, and supportive. "Addictive" qualities of gaming can encourage compliance with a rehab plan—one of the largest barriers to successful recovery. More availability and improved compliance could lead to a better quality of life for many stroke survivors, easing the burden on caregivers and society in general.