01

Why

The Agilik™ smart orthosis helps patients retain or increase their independence and mobility. This is especially critical in children with cerebral palsy, spina bifida and other knee-extension-deficiency disorders whose strength and endurance often deteriorate as they get older. The Agilik™ functions by assisting or resisting knee extension and flexion throughout the gait cycle. Approximately 50% of adolescents with CP who can walk, will be unable to do so in early or middle adulthood.* Our hope is to stop, or even reverse, this deterioration specifically by reducing crouch gait, increasing extension and strengthening their legs, enabling them to Stand Taller, Walk Stronger.™

  • Improve range of knee motion during walking
  • Increase walking efficiency and reduce fatigue
  • Rebuild weakened muscles
  • Enhance overall mobility and walking function

 

*Bottos, M. and Gericke, C., Ambulatory capacity in cerebral palsy: prognostic criteria and consequences for intervention. Dev Med Child Neurol, 2003. 45(11): p. 786-90.

02

WHAT

Designed as a gait rehabilitation device, the Agilik smart orthosis moves with the wearer, providing dynamic knee assistance and resistance, when needed during a patient’s gait. This helps patients with crouch gait stand more upright, gain muscle strength, and learn to walk more efficiently and with more independence. The Agilik is designed to be light, easy to doff and don, and comfortable, similar to a KAFO (knee, ankle, foot orthosis). The Agilik is not an exoskeleton intended to hold a patient up and walk for them, but instead a rehabilitation device designed to actually improve the user’s gait.

  • Non-invasive rehab solution
  • Customizable for each patient’s changing condition and their growth
  • Proven wearable technology
  • Smart system: real-time gait analysis drives assistance for flexion and extension
  • Flexible, personalized design for assisting children 5 years old and older, and small adults with body weight up to 70kg/154lbs.
  • For clinic and home rehabilitation use

03

HOW

Through the use of advanced sensors and joint motors the Agilik smart orthosis can measure knee angles, knee angular velocity, heel strike and toe off and adjust the amount of assistance during specific phases of gait, aiding the user in standing and improving knee extension. During other phases of gait, the orthosis resists against the user’s muscles to help improve strength. Our app-based interface allows therapists and researchers to control the Agilik’s torque and timing.

The device provides user gait metrics, including range of motion, maximum flexion and extension angle and speed, as well as utilization tracking (for how long and how frequently the Agilik was used), that enables therapists to make informed decisions for the therapy of their patient. Our goal is to enable users to Stand Taller, Walk Stronger.™

04

WHO

The Agilik smart orthosis is intended solely for orthotics of the lower limbs and is intended for use by ambulatory patients. The Agilik is intended for forward walking on level surfaces when the power is turned on, not for sports or aggressive use. The Agilik is indicated for patients who exhibit knee instability in the sagittal plane while bearing weight during the stance phase of their gait cycle. This includes but is not limited to patients with crouch gait from spina bifida or CP.

The Agilik is a smart orthosis which assists the flexion and/or the extension of the knee, corresponding to patient movement. The Agilik cannot initiate the movement of the joint.

05

WHERE

Bionic Power’s solution is designed for use in clinic-based rehabilitation, enabling more frequent and extensive, longer-term training and reinforcement of new gait patterns for the brain (neuroplasticity). Our ongoing trial, patient after patient, is  showing a concrete benefit in gait biomechanics as well as a “training effect” (session after session the quality of the patient’s natural gait tends to improve), leading to the interesting hypothesis that the benefits of longer-term use might be based on a sort of rewiring of the user’s brain, enabling them to achieve benefits from the gait training that last after the orthosis is removed. The exact duration, efficacy, ideal length and intensity of training are variable and based on multiple factors and should be discussed with the treating physician. You can read published papers on the trials on our Research page.

06

WHEN

The Agilik smart orthosis is coming soon! Our product (available today to clinical trials patients) is going through the registration process with regulatory agencies in the US and Canada. Production in 2022 will be limited to approximately 100 devices. Sign up to stay in the loop and get notified when we open the waiting list. If you believe the Agilik may help you or a patient under your care, contact us for more information about current and future trials.

Contact us for information about the availability of research units.

More information on ongoing trials can be found here.

07

COST

We will launch an Agilik pre-order campaign in the near future! Sign up to stay in the loop and get notified about our progress

A clinical evaluation is ongoing at the NIH in Bethesda, MD. They are actively looking for volunteers to enroll in the trial. If you believe you or your child/patient may be a good candidate and you can be in the Bethesda area, please review the study description and eligibility information here. Contact details for Dr. Bulea and Mr. Matsubara are also contained on that page.

We’re envisioning a device with the potential to dramatically improve the quality of life of patients with impaired gait. As an example, the current standard of care for children with CP and other knee-extension-deficiency disorders is an expensive combination of multiple surgeries, medications to reduce muscle tightness and pain, and physical therapy. If we are successful, the Agilik will significantly improve their quality of life at a substantially lower cost.

Costs for research uses of the Agilik are currently being discussed on a case-by-case basis.

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