The recent introductory webinar for the Bionic Power Agilik™ smart orthosis garnered considerable interest and thoughtful questions from clinicians across the country. Below, we’ve compiled answers to some of the most common questions from the session to help you better understand how the Agilik fits into clinical practice, early clinical study outcomes, cost, access, and more.
Clinical Application & Patient Suitability
Clinicians were especially interested in how to identify appropriate patients for the Agilik. This device is designed for pediatric and select adult patients with neurological and musculoskeletal gait impairments affecting mobility and function, such as stroke, cerebral palsy, or spina bifida.
Clinical indications include:
- Knee-extension deficiency due to neuromuscular conditions
- Progressive crouch gait or fatigue with distance walking
- Quadriceps/hamstring weakness causing stance-phase instability
- Sagittal plane knee instability in ambulatory patients
- Compensatory gait strategies linked to trunk or hip overuse
- Functional decline from fatigue, limiting mobility
- Need for high-repetition gait training to support neuroplasticity
Q: You mentioned that patients must be able to walk three meters—must they be able to walk three meters without orthoses and gait aids?
Patients must be able to walk at least three meters using any mobility aid—KAFO, AFO, walkers, or crutches—even without the Agilik. This is because the Agilik does not force movement; it simply responds to the patient’s own motion, enhancing the flexion or extension they are already producing.
Q: Would you recommend a trial for a child under six?
The Instructions For Use (IFU) suggests more than five years of age and more than three feet tall. These requirements are based on biomechanics and cognitive development considerations. A trial is indicated for ‘proof of concept’ and help with determining efficacy and benefit.
Q: Would this device be suitable for an individual with cognitive delays or impairments?
It can be used by individuals with cognitive delays if they have strong caregiver support, can follow basic commands, and can express discomfort. Given the device’s application of external force, these are essential for safe use.
Q: Would this be able to accommodate patients with unique foot anatomy?
The system can also accommodate a range of anatomies through custom KAFO fabrication, though suitability must be determined on a case-by-case basis.
Q: Are there weight limits with this device?
The Agilik joint has a weight limit range between 20 and 125 kilograms, unless any other KAFO component is subject to a more stringent weight range. For patients above 70 kilograms, we recommend using a medial hinge at the knee.
Q: Is there a limitation to how much of a plantarflexion contracture the patient can present with to successfully use the Agilik?
The limit in plantarflexion contracture is a case-by-case decision. Generally, the larger the contracture, the more difficult the treatment is. Usually, contracture above -15 to -20 degrees may impede the function of the orthosis.
SPS and Bionic Power provide hands-on clinical onboarding to help determine indications and contraindications for use.
Clinical Evidence & Research
The Agilik is backed by an IRB-approved clinical study demonstrating improvements in mobility, endurance, and quality of life for pediatric patents. While still collecting exit surveys, initial clinical study results demonstrate:
- Quality of life, as measured by the EQ-5D-Y-3L, improved steadily from baseline through three months.
- Patient-reported mobility scores decreased at one month but improved by two months and remained stable through three months.
- Average TUG time increased at one month, then improved slightly and stabilized at three months.
- Average walking distance declined at one month, then gradually improved, approaching baseline, by three months.
Q: How many patients are using the device clinically?
As this is new technology, this number is limited mostly to the NIH and Hanger trials. The number of Agilik users outside of the trials is growing.
Q: What is the longest time a patient has been using the device?
A Bionic Power patient is approaching 18 months of use. A few Hanger Clinic patients will soon reach the one-year mark.
Q: From your study, how do you feel like GMFCS level IV patients did with the Agilik?
In our study, the GMFCS level IV participant demonstrated biomechanical improvements with the Agilik. However, level IV individuals may experience additional challenges depending on their assistive device. For example, walkers must provide enough clearance to accommodate the added width of the Agilik and avoid interfering with limb progression. In practice, the level IV participant (and some level III participants) chose to use the Agilik during designated ambulation periods rather than wearing it throughout the day.
Q: Do you see improvements in certain measures such as range of motion, distance walked, and endurance levels?
While our study did not systematically track measures outside of follow-up visits, patient feedback suggested improvements in walking capacity and endurance. The Two-Minute Walk Test (2MWT) served as our closest proxy for endurance. Pediatric participants initially showed a decline in distance walked, but over three months their performance gradually improved, approaching baseline levels. We did not specifically evaluate range of motion, though we anticipate that long-term use of the Agilik could contribute to improvements in this area.
More on range of motion and other biomechanical benefits can be found here.
Q: Have you done studies on adults or long-term studies?
The experience of adults is still anecdotal.
Q: Is there an ongoing research program that the pediatric population can take part in?
Yes, NIH still has an ongoing trial. Learn more here.
Device Functionality & Features
The Agilik assists or resists knee extension and flexion throughout the gait cycle. It monitors key aspects of leg movement during each step and uses this information to adjust the amount of assistance or resistance. This targeted assistance helps improve knee extension, reduce fatigue, support upright posture, and promote strength. The device also collects gait metrics like range of motion, maximum flexion, and extension and angle speed to help clinicians make data-driven care decisions.
Q: Does the brace automatically adjust the resistance when walking on level/unlevel surfaces or is that only done by the app?
The brace does not recognize terrains for now, but it does automatically modulate torque in order to reach full extension in late swing and stance without hyperextending.
Q: How much does the device weigh?
The Agilik unit is about 600 grams per leg, with less than one kilogram added for the battery pack. The weight of the KAFO structure depends on several factors.
Q: Would you be able to use the Agilik in a more restrictive gait trainer such as the Rifton Pacer or the KidWalk?
Yes, provided that the pacer is large enough to allow the patient to wear the Agilik KAFO.
Q: Can the Agilik help control hip rotation?
While the Agilik itself does not control hip rotation, it could be done via KAFO by adding a hip component if deemed appropriate.
Q: When do you recommend using a medial follower with the lateral Agilik?
When the patient's weight is more than 70 kilograms and in all other cases when the orthotist deems it appropriate.
Access, Cost, and Insurance
Many attendees asked about reimbursement pathways for the Agilik. Coverage can vary based on payer type, diagnosis, and documentation. Some Medicaid and private insurance plans have covered the device when appropriate clinical justification is provided.
Each state’s Medicaid program will make independent decisions on coverage. Optional documentation and reimbursement support is available through O&P Insight with an additional cost.
Take the Next Step
As interest in the Agilik continues to grow, SPS is excited to offer training opportunities in 2026. There will be more to come on that soon—in the meantime, complete the form below to be notified when training becomes available.
If you have additional questions, please reach out to Curt Bertram at cbertram@spsco.com.
