ABOUT THE AGILIK

FAQ

The Agilik is a wearable, smart orthosis designed to correct crouch gait. It assists with hip and knee flexion to reduce undue strain on the wearer’s leg muscles, which can worsen gait and mobility over time.

The Agilik is designed specifically to treat crouch gait. Crouch gait is seen in some patients with cerebral palsy, spina bifida, incomplete spinal cord injury, and muscular dystrophy, but not all. Therefore, the Agilik is not designed to treat any one of the aforementioned health conditions, but specifically the gait pathology known as crouch gait.

The Agilik is unique in that it provides both assistance and resistance to its wearer to correct and support gait. It provides each individual user with the specific supportive boost they need to optimize their motion at each phase of gait. In this regard, it is both a training and mobility support device.

Most leg-based exoskeletons hold their user up and in effect, walk for the user, controlling their gait. The Agilik offers an assistive boost while allowing the wearer to retain all motor control of their legs, only offering support when the user initiates movements. In addition, the Agilik offers both knee extension AND flexion assistance (or resistance if desired for muscle strengthening).

The Agilik does not “walk for” the patient nor control their body movements. Rather, its dynamic robotic assistance works to improve users’ gait over time, helping them to extend their knees and stand more upright and if needed, to flex their knees more to prevent catching one’s foot on the ground during a step. The device is normally worn as a pair of orthoses, with one orthosis worn on each leg. The device applies up to 12 Nm to the knee joint to both flex and extend the knee.

While the conditions that may cause crouch gait, such as cerebral palsy and spina bifida, may not themselves be progressive, the long-term impact of crouch gait on the body can deteriorate mobility and ambulation throughout one’s lifespan. Crouch gait excessively strains the muscles and joints involved in walking, resulting in increased spasticity and degeneration. This damage may become so extensive that a previously ambulatory individual may come to rely on a wheelchair later in life; it is estimated that nearly half of adults with cerebral palsy use a wheelchair, while nearly 75% report experiencing pain. The Agilik is designed to mitigate these symptoms through rehabilitating crouch gait.

Yes, the more frequently the patient uses the Agilik, the better!

This depends greatly upon the amount of torque used and other factors. A person can use the Agilik for about 2 hours at the highest torque setting and non-stop walking. Most users will see battery lives of between 4-8 hours of actual walking. The Agilik’s service life is 6 years and it can be mounted on a new KAFO if growth or damage causes a new KAFO to be needed.

The patient’s orthotist and physiotherapist collaborate to tune the parameters and settings of the Agilik. Once the patient has familiarized themselves with the device and is able to walk with it in a clinical setting, their team will make the determination that they are ready to use it at home. Use of the tuned Agilik is simple and the power can be turned on and off with the touch of a button on each leg.

The Bionic Power team (or your local distributor) provides training and ongoing support for patients’ healthcare providers. These certified therapists will train their patient in the use of the Agilik. Each device comes with a detailed manual outlining instructions for use for the patient, the therapist and the orthotist, including instructions for using the Agilik App (to be used only be BPI trained therapists or doctors).

The patient’s orthotist, doctor, Bionic Power professionals, and physical therapists collaborate on the device’s customization, tuning, and implementation. An individual’s doctor may recommend the device or they may contact Bionic Power to learn more. Bionic Power then requires a description of the patient’s diagnosis to be sent by either the doctor, patient, or physiotherapist to inform their recommendation of whether the Agilik would be a good fit for the patient. In addition to a description of the diagnosis, Bionic Power requires a video of the patient walking to get a sense of their gait and the corrective support they require. Bionic Power sells the device to the patient’s orthotist who builds a custom KAFO, attaches the Agilik to the KAFO, and sells the entire system to the patient. The orthotist can also assist in facilitating insurance coverage for the device. Agilik users then work with a certified physical therapist trained in the use of the device to learn how to use the device in a clinical environment, after which they are able to take it home and integrate it into their daily routine.

THE AGILIK
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Designing the Agilik

Bionic Power designed the Agilik—its smart orthotic device—for people with crouch gait from cerebral palsy or another knee-extension-deficiency disorder. What makes it different from the other orthotics out there is that it not only helps its users to stand taller and walk stronger, giving people more autonomy, but has the potential to increase motor control as well.

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THE AGILIK
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What Crouch Gait Clinical Trials Tell Us About the Agilik

If you’re someone with cerebral palsy or spina bifida or some other knee-extension-deficiency disorder, or you’re the parent of a child with one of these conditions, you’re probably already familiar with orthotic devices. Ours – the Agilik™ – is different and we’d like to share more about our ongoing and planned clinical trials. Who knows? Maybe you’ll want to apply to participate in one of them!

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AGILIK Videos:

Video Info

This animation about the Agilik smart orthosis showcases how our device, designed for those who experience crouch gait due to spina bifida or cerebral palsy, will help users walk with increased extension, confidence, and endurance.

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Hemiparesis

Hemiparesis is a neurological motor impairment where the muscles on one side of the body are weaker than on the other. Want to learn more? Check out this article!

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About Cerebral Palsy

Cerebral palsy (CP) covers a group of disorders that affects a person’s ability to move and maintain balance and posture. It’s the most diagnosed childhood motor disability in the United States and Canada. About 10,000 American babies are born annually with CP, while each year 1,200-1,500 school-aged children are diagnosed with the disorder.

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About Spina Bifida

There are nearly 1,500 American babies born each year with the spinal birth defect spina bifida. Most of them have trouble moving and face disabilities ranging from mild to severe.

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Crouch Gait: Causes, Issues, Treatments

Crouch gait, the abnormal walking pattern often seen in children with cerebral palsy and other knee-extension-deficiency disorders, is not only painful but can often lead to worse issues as a child ages—bony deformities, degenerative arthritis, joint abnormalities. It’s best, then, to treat it early.

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A Primer on Bionic Power, the Agilik, and Wearable Devices

If you’re reading this, you might be the parent of a child with cerebral palsy. Or spina bifida, muscular dystrophy, or some kind of incomplete spinal cord injury or knee-extension-deficiency disorder. Something that has somehow compromised your child’s ability to stand, walk, and move with ease, purpose, and joy.

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Questions about CP and SB

Crouch gait (sometimes called flexed knee gait) is characterized by excessive flexion of the knee, hip and ankle during the stance phase of gait. This gait is typical of many people with CP or spina bifida, especially after puberty and growth spurts, where their muscles may not keep up with their weight gains. When a person with a typical gait is in stance (and their other leg is swinging forward), their knee extends all the way. This enables them to get some support from their skeleton itself and not just their muscles. Try standing in a crouch for a few minutes then straighten out. See how much easier it is when your legs are straight? A person with crouch gait doesn’t extend fully so is holding themselves up with muscles during all of walking, making it extra tiring and causing extra wear and tear on their knee.


Kedem, P., & Scher, D. M. (2016). Evaluation and management of crouch gait. Current opinion in pediatrics, 28(1), 55–59. https://doi.org/10.1097/MOP.0000000000000316

85 – 90% of cerebral palsy cases are congenital, meaning that the condition is present starting from birth. Cerebral palsy results from brain damage (such as perinatal stroke or oxygen deprivation) or abnormal development of the brain that can occur before, during, or after birth. When cerebral palsy develops after birth (months or even years into the lifespan while the brain is still developing), this is called acquired cerebral palsy and is much less common.


CDC. (2023, October 6). Causes and Risk Factors of Cerebral Palsy. Centers for Disease Control and Prevention. https://www.cdc.gov/ncbddd/cp/causes.html ‌

Spina bifida is a birth defect resulting from the improper formation of the spinal cord during the first month of pregnancy. A portion of the neural tube does not properly close, creating complications in the spinal cord. The severity and type of spina bifida varies greatly depending on the size. Spina bifida develops in the first few weeks of pregnancy, as this is when the neural tube forms. Certain actions, like taking folic acid and avoiding alcohol and hot tubs during pregnancy, can dramatically reduce the risk of having a baby with spina bifida.


CDC. (2020, September 1). What is Spina Bifida? Centers for Disease Control and Prevention. https://www.cdc.gov/ncbddd/spinabifida/facts.html

Cerebral palsy is not generally considered to be genetic, as it is typically caused by external factors resulting in damage to the brain. However, some genetic factors may play a small role regarding obstetrics and conditions that can complicate birth. Some obstetric genetic factors include placental disruption, premature birth, growth restriction, preeclampsia (high blood pressure during pregnancy), chorioamnionitis (inflammation of fetal membrane), and breech which may increase the risk of prenatal stroke, forming an indirect link between cerebral palsy and genetics.


Chorioamnionitis and Cerebral Palsy – Cerebral Palsy Guidance. (2022, January 7). Cerebral Palsy Guidance. https://www.cerebralpalsyguidance.com/cerebral-palsy/causes/chorioamnionitis/

Cerebral Palsy Guide. (2023, February 2). Cerebral palsy risk factors – what to watch out for. Cerebral Palsy Guide. https://www.cerebralpalsyguide.com/cerebral-palsy/causes/risk-factors/ ‌

While doctors have not yet determined with certainty the exact factors that cause spina bifida, there is a consensus that a combination of environmental, genetic, and nutritional factors (such as a family history of neural tube defects) play a significant role. For example, a family history of neural tube defects and folate deficiency could potentially increase the risk factor for spina bifida.


Spina bifida. (2021). https://www.marchofdimes.org/find-support/topics/planning-baby/spina-bifida

Spina bifida – Symptoms and causes. (2022). Mayo Clinic; https://www.mayoclinic.org/diseases-conditions/spina-bifida/symptoms-causes/syc-20377860 ‌

Cerebral palsy affects mobility by causing muscle stiffness, poor coordination, and muscle weakness, leading to difficulties in movement and motor skills. Running and walking ability varies amongst individuals with cerebral palsy. Some people may experience gait pathologies when walking or running, such as scissoring or crouch, while others may rely on a wheelchair. It is not uncommon for cerebral palsy patients who once walked unaided, to use a wheelchair later in life.


Classification of Gait Patterns in Cerebral Palsy. (2023). Physiopedia. https://www.physio-pedia.com/Classification_of_Gait_Patterns_in_Cerebral_Palsy ‌

Elisabet Rodby‐Bousquet, & Gunnar Hägglund. (2010). Use of manual and powered wheelchair in children with cerebral palsy: a cross-sectional study. BMC Pediatrics, 10(1). https://doi.org/10.1186/1471-2431-10-59 ‌

Spina bifida affects mobility by potentially causing paralysis or weakness in the lower limbs due to incomplete spinal cord development and neural tube defects. Like cerebral palsy, spina bifida can result in gait pathologies and difficulties with running and walking.


Spina bifida – Symptoms and causes. (2022). Mayo Clinic; https://www.mayoclinic.org/diseases-conditions/spina-bifida/symptoms-causes/syc-20377860

According to the US CDC, 1 in 345 children has cerebral palsy.

According to the US CDC, approximately 1427 babies with spina bifida are born in the United States each year, amounting to 1 in 2758 births. Many of these are spina bifida occulta that may go undetected for a person’s entire life, with no effect.

Cerebral palsy is technically not progressive. However, complications, such as increased spasticity, can arise from gait pathologies resulting in improper muscle use which negatively affect walking over time. Individuals’ leg muscles can stiffen over time, causing previously ambulatory patients to rely on wheelchairs and/or other mobility supports.


Cerebral Palsy Guide. (2023, February 2). Adults With Cerebral Palsy – Resources, Support and Helpful Information. Cerebral Palsy Guide. https://www.cerebralpalsyguide.com/community/cerebral-palsy-in-adults/ ‌

Spasticity. (2021, August 8). Hopkinsmedicine.org. https://www.hopkinsmedicine.org/health/conditions-and-diseases/spasticity ‌

 

 

 

 

 

The progression of spina bifida varies depending on its type. The type of neural tube defect, as well as its location on the body and its operability, determine its degree of impact on the individual and the potential for symptoms to exacerbate over time. The least severe form of the condition, spina bifida occulta, may go undetected by patients unless they experience changes in their leg muscles, incontinence, or unexplained back pain. The more severe forms, meningocele and myelomeningocele (the most severe), may result in post-operative nerve damage and sensory issues.


Spina bifida – Symptoms and causes. (2022). Mayo Clinic; https://www.mayoclinic.org/diseases-conditions/spina-bifida/symptoms-causes/syc-20377860

Cerebral palsy is often detected through clinical evaluation of a child’s movement patterns, developmental milestones, and neurological assessments. Cerebral palsy symptoms may be apparent in babies as young as under 6 months old, such as crossed or scissored legs upon being picked up. Babies with cerebral palsy may also miss mobility milestones, such as crawling; lopsided crawling and scooting on buttocks instead of crawling are two early signs of cerebral palsy.


CDC. (2023, October 6). What is Cerebral Palsy? Centers for Disease Control and Prevention. https://www.cdc.gov/ncbddd/cp/facts.html ‌

Spina bifida can be detected through prenatal screening, ultrasound, and other diagnostic tests. It is often detected in utero. For the more severe forms of the condition, the neural tube defect may be visible from the exterior of the body.


CDC. (2020, September 1). What is Spina Bifida? Centers for Disease Control and Prevention. https://www.cdc.gov/ncbddd/spinabifida/facts.html

There are many therapies and interventions which are proven to improve quality of life and manage symptoms of those with CP, but there is no cure.


CDC. (2023, October 6). What is Cerebral Palsy? Centers for Disease Control and Prevention. https://www.cdc.gov/ncbddd/cp/facts.html

Spina bifida is detectable in utero and, in some cases, operable in utero, allowing for the continuation of a pregnancy post-surgery. Neural tube defects are surgically correctable, but may cause some complications depending on the severity of the defect. Further, some preventative measures for pregnant people include avoiding extreme heat (ex: not going into hot tubs), avoiding alcohol, and taking folic acid during pregnancy. Folic acid consumption during pregnancy decreases the risk of neural tube defects by upwards of 70%.


Understanding Spina Bifida – Hydrocephalus Canada. (2022, August 15). Hydrocephalus Canada. https://www.hydrocephalus.ca/spina-bifida-info/understanding-spina-bifida/

INTERVIEWS

INTERVIEW
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Interview with Agilik Clinical Study Participant NB

NB was an NIH trial participant. She walked with the Agilik for 10 sessions. We asked her about her experience and here is she said:
BPI: Do you think using the Agilik was helpful?
NB: Using the Agilik increased the mobility in my legs. I was able to bend my knees more, have a slightly longer stride in my step, walk a little faster, and even stand a little taller.
That’s what we like to hear! The Agilik helping people Stand Taller and Walk Stronger.

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