The most common assistive device for foot drop is a piece of rigid plastic. It is called an ankle-foot orthosis, or AFO, and it works by locking the ankle in place, preventing the foot from dropping and catching on the ground. For the roughly 10 million people globally who live with this gait impairment, often a result of stroke, multiple sclerosis, or cerebral palsy, the trade-off is stark: stability for natural movement, safety for comfort. Sole 1, a project emerging from Harvard’s engineering and design labs, is betting that a sock woven with synthetic muscles and guided by artificial intelligence can break that compromise [James Dyson Award, 2025].
The Wedge of Soft Robotics
Sole 1’s core innovation is its departure from rigid mechanics. Instead of a plastic brace, the system uses soft, textile-integrated actuators,described as synthetic muscles,that contract and relax in response to sensor data. A machine learning model processes movement data in real time, orchestrating these actuators to provide dynamic support precisely when needed during the gait cycle [James Dyson Award, 2025]. The goal is a device that feels less like medical equipment and more like adaptive clothing, aiming for the comfort required for all-day wear. This soft robotic approach represents a distinct wedge into the orthotics market, challenging decades of incremental improvement on static bracing with a fundamentally different material and control philosophy.
An Academic Project in Transition
The company’s origins are firmly in academia. Its CEO and co-founder, Bradley Scott Wagman, is developing Sole 1 as part of his Master in Design Engineering thesis, a joint program between Harvard’s Graduate School of Design and its School of Engineering and Applied Sciences [Harvard Graduate School of Design, May 2025]. Public recognition has come through design and engineering awards, most notably a feature in the James Dyson Award, rather than commercial milestones or venture funding announcements [Sole 1 LinkedIn, 2025]. The available evidence paints a picture of a promising research prototype seeking a path to the clinic. The team’s composition and any institutional backing beyond the university are not detailed in public channels, placing Sole 1 squarely in the pre-seed, pre-commercialization phase where technical validation is the primary currency.
The Path to a Regulated Product
The ambition is clear, but the runway is long and lined with regulatory signposts. For Sole 1 to reach patients, it must first navigate a gauntlet of clinical and commercial hurdles that many hardware-focused health tech startups underestimate.
- Clinical validation. The AI’s gait orchestration claims require rigorous peer-reviewed studies to demonstrate safety and efficacy superior to the standard of care. A prototype winning a design award is step one; a published clinical trial is another.
- Regulatory clearance. As a device that physically assists movement, Sole 1 will almost certainly require FDA clearance, likely as a Class II medical device. This process demands substantial resources and time, often measured in years, not months.
- Manufacturing and scaling. Translating a lab-built prototype with embedded actuators and sensors into a reliable, washable, mass-producible consumer product is a profound engineering challenge with significant cost implications.
The absence of disclosed funding or commercial partnerships suggests these are future battles. The company’s success will hinge on its ability to attract capital and expertise capable of steering it through this development valley of death, not just the elegance of its initial concept.
The Patient at the End of the Gait Cycle
For all the talk of synthetic muscles and adaptive algorithms, the ultimate test for Sole 1 is in the daily life of a person with foot drop. This population, which includes survivors of stroke and individuals with neurological conditions like multiple sclerosis, currently relies on a limited toolkit. The standard ankle-foot orthosis, while effective at preventing falls, is often cited as uncomfortable, bulky, and aesthetically unappealing, which can lead to reduced wear time and social stigma. Alternative treatments include functional electrical stimulation devices, which use electrodes to stimulate nerves, but these can be costly and require precise fitting.
Sole 1’s bet is that a comfortable, sock-like device that works in harmony with the body’s natural motion could dramatically improve adherence and quality of life. It is a humane engineering challenge, aiming to restore not just mobility but also dignity. The next twelve months will be critical for the team to move from award-winning prototype to a device ready for its first controlled pilot studies, translating academic promise into tangible patient benefit.
Sources
- [James Dyson Award, 2025] Sole¹ project page | https://www.jamesdysonaward.org/en-US/2025/project/sole
- [Harvard Graduate School of Design, May 2025] Facebook post on Sole 1 and MDE student | https://www.facebook.com/HarvardGSD/posts/sole-1-developed-by-bradley-scott-wagman-mde-26-ceo-and-co-founder-alongside-vik/1439003011594925/
- [Sole 1 LinkedIn, 2025] Company post on James Dyson Award | https://www.linkedin.com/posts/sole1_sole1-jamesdysonaward-footdrop-activity-7374119303853387776-_Vfz
- [Sole 1, retrieved 2026] Company website | https://www.thesole1.com/