Development of a novel, cost-effective gait training device utilized at home for the neurological patient population

Project Summary/Abstract In the U.S. over 5 million people are living with paralysis at an annual cost of over $200B to the healthcare industry, over half of which is due to stroke patients. It has been reported that over 25% of stroke patients identify as “non-community walkers” and almost 66% have ongoing issues with mobility in the five years following their stroke. The American Stroke Association recommends exercise therapy and gait training for stroke survivors, as the inability to walk can contribute to secondary health complications such as muscular atrophy, increased incidence of urinary tract infections, skin sores, falls, decreased bone density, presence of muscle spasticity, impaired lymphatic and vascular circulation, impaired digestive function, and reduced respiratory and cardiovascular capacities. Unfortunately, adherence to clinic-based exercise programs is poor, with up to 50% of patients stopping within 1 year, and in-patient costs for stroke rehabilitation can exceed $70,000 annually. In addition to costs, barriers such as lack of access to rehabilitation centers, limited physical abilities, and limitations in individualized rehabilitation plans all prevent patients from pursuing gait training. An in-home solution for exercise therapy and gait training would eliminate many of these barriers, however the limited options for rehabilitation devices currently on the market all have shortcomings that prevent them from meeting clinical needs. Exoskeletons are incredibly expensive, don’t offer body weight support to prevent falls during use, typically require 1-2 assistants for use, and don’t offer high volume gait training. Exoskeletons instead serve as mobility aids, rather than systems for exercise therapy or gait training. Treadmill and track systems share many of the same shortcomings. A system that offers overhead support for fall prevention is prohibitively large and expensive for home use, and 2-4 clinicians are required to facilitate manual ambulation of the patient’s legs. Additional device offerings such as ellipticals, FES bikes, etc do not provide any body weight support and thus are only meant for exercise, rather than high-dose gait training. At Healing Innovations we are developing a novel device whose value proposition is providing high-intensity gait training in the home to improve patient outcomes. Our Rise&Walk InHome (RWH) brings the benefits of clinical gait training to the home setting. The RWH offers body weight support during the sit-to-stand transition, as well as during therapy. The innovative motor and linkage system provides assisted gait training to guide the patient’s arms and legs during use. All of this is combined with an online platform to foster community engagement and allow customized therapy plans. Finally, this system is a fraction of the cost of clinical devices. Through this proposal we will finalize our device and software design through iterative development before testing the device in a pilot clinical trial to demonstrate its safety and efficacy during home use. We anticipate a large market for this device among stroke patients, and in the future we plan to rapidly expand into spinal cord injury and traumatic brain injury markets as well.