By Frank Long
The lower extremities provide the power behind some of the most important tasks in human physiology, including the ability to walk, run, swim, or pedal. Protecting and promoting the functional ability of the lower extremities is a vital part of maintaining good health and quality of life, whether an individual is affected by stroke-related paresis or ankle pain caused by an athletic injury. Braces and orthoses designed to provide support and stability to the lower extremities can help address some of these issues—especially those of the foot and ankle—by providing a nonsurgical assist that may improve gait or enable an individual to continue to participate in a favorite activity.
Manufacturers across the country have been busy improving the design features of braces and orthoses, and representatives from several of those manufacturers share the latest developments in this Physical Therapy Products Q&A. These products range from low-cost, off-the-shelf braces to functional electrical simulation devices used to treat foot drop to lightweight and flexible ankle foot orthoses (AFOs). Taking part in this Q&A is Ryan Petruska, Marketing Manager, Active Ankle; James C. Button, CEO, Allard USA Inc; Joel Behnke, Sr Director, Marketing, Bioness Inc; and Tom Kuelbs, Orthotics Market Manager, Ottobock North America.
Describe the newest brace/orthotic your company offers to the PT market. Explain whether its development was driven by customer demand or an advance in technology.
Ryan Petruska: Most of the bracing that the company focuses on are ankle supports, but supports for wrist, knee, elbow, and other body parts are offered as well. The newest ankle brace that the company currently offers to the PT market is the Eclipse. The Eclipse I is a single upright ankle brace designed to provide superior mobility, while the Eclipse II is a dual upright ankle brace designed to provide the maximum protection available in a rigid ankle brace through its solid u-shaped design. The development for these two new ankle braces stemmed from the customer demand for an ankle brace that provided the appropriate mix of protection and mobility.
James C. Button: On October 1, 2016, Allard USA introduced its newest ankle-foot orthosis (AFO), the Ypsilon flow. A technological innovation, the Ypsilon flow was developed by Allard in response to customer demand for a lighter weight, less rigid AFO providing maximum range of motion and flexibility for those seeking to be more active. The Ypsilon flow has a lower heel height, lower profile strut, and sleeker foot bed design with a less pronounced forefoot rise, enabling users to wear a greater variety of shoes.
Joel Behnke: The L300 Go System, intended to treat adult and pediatric foot drop and/or thigh weakness in adults using functional electrical stimulation (FES), received FDA clearance in January 2017. L300 Go builds upon the global success of the L300 Foot Drop System and L300 Plus System with numerous advancements, including the introduction of 3D motion detection of gait events, multi-channel stimulation, and a mobile iOS application to track user activity. Development was driven primarily by the need to improve clinical efficiency and reduce setup time, as well as the significant technology advances since the original L300 was made commercially available.
Tom Kuelbs: Ottobock’s family of WalkOn ankle foot orthoses was developed to help those with drop foot to be more mobile, safe, and independent. WalkOns are fabricated from advanced prepreg carbon composite material and help users with dorsiflexion weakness walk more naturally. WalkOn AFOs are lightweight, low profile, and extremely tough. And their dynamic design provides a more physiological and symmetrical gait, offering fluid rollover and excellent energy return.
What functions and features do PTs most tell you they want from braces and/or orthotics?
Ryan Petruska: What we hear mostly from physical therapists is that they are looking for a brace that provides the appropriate level of support and mobility. Most importantly, this brace has to provide a comfortable fit for patients.
James C. Button: In an independent study of 123 patients with mixed neuromuscular diagnoses conducted recently by The Ohio State University Wexner Medical Center Department of Neurology, the most common reasons given for preferring ToeOFF and BlueROCKER AFOs “were that the braces were lighter in weight, cooler to wear, assisted at push-off during ambulation and allowed them to wear a normal-sized shoe.” This study is published in the February 2017 issue of Muscle & Nerve.
The following companies provide products to treat ankle injuries, foot drop, and other aspects of stroke and neurological rehabilitation:
Allard USA Inc
GAITRite/CIR Systems Inc
Motorika Medical Ltd
Joel Behnke: As the value-based healthcare revolution takes hold, the importance of clinical efficiency becomes a predictor of technology utilization. Clinicians mandate quick set-up times, repeatable results, and solutions that are backed by medical evidence. With the introduction of 3D motion detection and multi-channel capabilities, the treating clinicians have a solution to easily set-up the L300 Go and optimize simulation settings depending on clinical presentation. Clinicians also demand insight into how their patients are using the medical equipment to ensure compliance and promote long-term outcomes. Integrating activity tracking keeps patients motivated and ensures transparency on compliance while in the community.
Tom Kuelbs: Physical therapists have told us they want lower extremity AFOs that will help users to restore or maintain their range of motion and provide a safe and more natural gait pattern. Additionally, orthotic solutions need to support their patients’ goals as well as be easy to use and durable.
What is the cost range of the bracing and/or orthotic products your company offers? What type of reimbursement (if any) is available for them?
Ryan Petruska: The cost range for most of our ankle bracing ranges from $20 to $50, depending on the type of bracing and support needed. These are not eligible for reimbursement.
James C. Button: Allard AFOs are typically offered by O&P practitioners for $850 to $1,200, depending upon the accessories, modifications, and
necessary customized fitting required for the individual patient. Fitting by a trained and certified orthotist/prosthetist will ensure the wearer benefits from optimal performance, comfort, and longevity from Allard AFOs. Medicare, Medicaid, and private insurance companies provide reimbursement at rates that depend on the location and insurer.
Joel Behnke: Bioness offers a range of lower extremity products to meet diverse patient presentations. Product configurations are based on clinical need with cost ranging from $540 to $13,880. The lower extremity product range is reimbursed by the Veterans Administration, where Bioness technologies have been implemented in more than 80 locations across the country. Additionally, specific configurations of the lower extremity product line have reimbursement available through CMS for incomplete spinal cord injury. Reimbursement through commercial insurance is superior and covers a large base of patients with more diverse diagnoses, including stroke and multiple sclerosis.
Tom Kuelbs: WalkOns are reimbursed by insurers and government agencies.
For what conditions can your company’s braces/orthotics be used?
Ryan Petruska: The Eclipse line assists in faster rehabilitation following an ankle injury. Both Eclipse I and II are rigid braces offering the highest level of preventative support.
James C. Button: The conclusion of the independent Ohio State University study published in the February 2017 issue of Muscle & Nerve is, “The overwhelming majority of ambulatory neuromuscular patients with distal leg weakness will benefit from off-the-shelf ToeOFF or BlueROCKER carbon fiber AFOs.” Diagnoses include Charcot-Marie-Tooth disease, stroke, multiple sclerosis, muscular dystrophy, cancer, peripheral neuropathy, spinal, and other nerve damage.
Joel Behnke: The L300 Go is intended for adults and pediatrics with foot drop and/or adults with thigh weakness as a result of an upper motor neuron injury or disease, which includes stroke (CVA), spinal cord injury, traumatic brain injury, multiple sclerosis, cerebral palsy, etc. The L300 has been shown to have statistically significant benefits during the continuum of care, acute to chronic.
Tom Kuelbs: WalkOns are ideal for patients with a variety of conditions and levels of paresis or paralysis, including those with weak dorsiflexion, slight knee extension impairment, post-stroke, traumatic brain injury, multiple sclerosis, neuromuscular atrophy, peroneal paralysis, Charcot-Marie-Tooth disease, and partial foot amputation. PTP