Walking Systems and Braces

Overview of Orthoses

Orthoses and braces are tools common in rehabilitation, though somewhat less than in years past. This is due in part to cost cutting, limited clinical expertise and reduced time in rehab. There is also a general feeling among many users that orthoses are cumbersome and appear too bionic or “disabled” looking.

An orthosis might be used for positioning a hand, arm or leg, or to magnify or enhance function. It can also be as simple as a splint or as a complex as functional electrical stimulation (FES) brace for ambulation in paraplegics.

Below are several options for orthoses and emerging devices.

Wrist-hand Orthosis

Wrist-hand orthosis (WHO) transfers force from an active wrise to paralyzed fingers. This offers a grasping function for those with cervical injuries (generally between C4-C7). The WHO, also called a tenodesis splint, has been modified and simplified over the years, sometimes with the addition of batteries for power.

Ankle-foot Orthosis

Ankle-foot orthosis (AFO) is commonly used in people who have experienced strokes, multiple sclerosis, and incomplete spinal cord injury to assist the ankle and allow the foot to clear the ground during the swing phase of walking. There are many varieties, most have a molded heel cup that extends behind the calf.

Knee-ankle-foot Orthosis

Knee-ankle-foot orthosis (KAFO) allows someone living with paralysis (usually L3 and above) to stabilize the knee and ankle. While it’s very hard work, people using KAFO’s, even those with no hip flexion, can take steps by swinging their legs while supported by forearm crutches. There are many types of KAFOs, including plastic and metal braces.

Reciprocating Gait Orthosis

Reciprocating gait orthosis (RGO), which originated in Canada for children with spina bifida, consist of a pair of KAFOs with solid ankles, locking the knee joints, and legs and thigh straps. Each leg of the brace is attached to a pelvic unite with a hip joint, supporting hip flexion and extension. A steel cable assembly joins the two hip joints to limit step length.

By rotating the torso, the user shifts the weight to the forward leg; this permits the opposite leg to move forward. This kind of walking is stable and balanced, but slow and requires a great deal of energy.

Clinicians have added FES to the RGO to assist walking.

Parastep

A parastep is a “neuroprothesis,” a device that affects both the structure of the body ( as a brace) and the nervous system (substitute for damaged nerves). It is a portable FES system that facilitates reciprocal walking by stimulating leg muscles on cue. The movement is a bit robotic, but independent and functional for short periods of time.

Most people with spinal cord injuries between T4 and T12 can use a Parastep, which requires a physical therapy regime of 32 training sessions. The device is covered by Medicare for qualified users. For more information, reach out to Sigmedics.

Exoskeleton

Exoskeletons and the role they are playing in both the rehabilitative care and home life of people living with paralysis became an important emerging technology only a few years ago. Essentially, exoskeletons are battery powered bionic legs, with small motors on the joints.

Companies suggest exoskeleton devices will do more than give users eye-to-eye contact with others. Health benefits may include better bone density and reduced pain. There is anecdotal evidence that robotic walking helps bowel and bladder function.

Exoskeleton Manufacturers

In June 2014, the Food and Drug Administration (FDA) approved the ReWalk Personal System for use in the home and in the community. It is the first exoskeleton device to be approved by the FDA. According to the company, the ReWalk: “Provides user-initiated mobility through the integration of a wearable brace support, a computer-based control system and motion sensors.”

ReWalk affords people living with paraplegia with the opportunity to both stand and walk independently, but the cost could be prohibitive for some — a recent article claimed the price of owning one of these devices is close to $70,000. ReWalk comes from Israel and Europe.

Ekso Bionics is currently testing its robotic exoskeletons at rehabilitation centers around the globe. According to the company, the device is intended for supervised use in a clinical setting by individuals with various levels of paralysis.

Ekso’s most recently-reported findings, from September 2012, were culled from a clinical trial of 13 individuals, 12 with paraplegia, and one with quadriplegia. The study found that walking and standing in Ekso’s device was feasible, and that improvements in function were made by training with the device. The company reported that walking speed and distance, fluidity, gait, and balance all improved. Ekso Robotic Exoskeletons are not currently approved for personal use in the United States.

The Parker Indego® is a “powered lower limb orthosis enabling people with mobility impairments to walk and participate in over-ground gait training.” The Indego was recently awarded FDA clearance to market and sell the exoskeleton for clinical and personal use in the United States (Indego is already commercially available in Europe). The company intends to commercially launch the device in the United States in the coming months.

In October 2015, Parker announced that it would supply Indego devices for a four-year U.S. Department of Defense-funded study of the tangible economic and rehabilitation benefits of exoskeletons.

In July 2014, the company tested an Indego device at the Shepherd Center in Atlanta, Georgia — it was the first time that it had ever been used by an individual living with quadriplegia — Cole Sydnor.

The Hybrid Assistive Limb (HAL), developed by Japanese robot maker Cyberdyne, is moving through the medical device approval processes.

Resources

If you are looking for more information or have a specific question, our Information Specialists are available business weekdays, Monday through Friday, toll-free at 800-539-7309 from 9am to 8pm ET.

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