Flyband-peds: evaluating biomechanics of integrated exoskeleton footwear for pediatric charcot-marie-tooth disease

The National Institute of Child Health and Human Development awarded Results Group, LLC $305,904 on August 1, 2026, under the Child Health and Human Development Extramural Research program (CFDA 93.865) to develop and test FLYBAND-PEDS, an exoskeleton-integrated high-top sneaker designed for pediatric patients with Charcot-Marie-Tooth disease.

FLYBAND-PEDS embeds a thin-walled, motorless exoskeleton within sneaker construction layers to provide ankle-foot orthosis-level support while maintaining comfort, minimizing visual distinction from standard footwear, and reducing interference with daily activity and freedom of motion. The Phase I effort includes decentralized gait study testing of pediatric prototypes and human-factors interviews with families, where multiple members often carry CMT diagnoses. This award addresses a documented 10-year gap between disease onset and initiation of current bracing treatment, aiming to enable earlier intervention that reduces maladaptive gait patterns and supports attainment of developmental growth milestones.

Results Group developed working prototypes through prior NIDILRR funding and reported positive responses from children with CMT and healthcare specialists during preliminary testing. The award runs through July 31, 2027, with place of performance in Glastonbury, Connecticut. Results Group is a small disadvantaged business with demonstrated federal experience in exoskeleton-integrated rehabilitation technologies across military and civilian health applications.

Abstract

Motive labs is developing a new pediatric brace known as flyband-peds that addresses the current 10-year GAP in the start of bracing treatment for children with charcot-marie-tooth (CMT) disease. CMT is a genetic disease, frequently impacting more than one member of a family. Losses in leg and foot strength lead to changes in walking, reducing daily activity and increasing risk of not meeting developmental growth targets. This cascade can lead to reduced resilience to CMT symptoms across the adult lifespan. Flyband-peds exoskeleton footwear enables earlier intervention, aiming to reduce maladaptive gait and the risk of not attaining growth milestones. We have developed working flyband-peds prototypes through a grant from the national institute for disability, independent living, and rehabilitation research (nidilrr). In preliminary interviews, children with CMT report that braces can be uncomfortable, bulky, high cost, interfere with freedom of motion, and have a medical aesthetic that makes them feel different from their counterparts who do not wear braces. By embedding a thin- walled, no-motor exoskeleton within the construction layers of a high-top sneaker, we aim to provide comparable support to an entry-level ankle foot orthosis (AFO) while being significantly more comfortable, less intrusive to daily activity, and in a form factor that does not require children to look different than their counterparts. Our prototype shoe has been received with enthusiastic responses by children with CMT and healthcare specialists. In this phase i effort, we propose to test these pediatric prototypes in a decentralized gait study and conduct human-factors interviews with families who often have more than one family member with CMT. We are confident in our ability to produce and test these prototypes given our demonstrated success in building other footwear and exoskeleton systems. To execute our gait study, we have identified a contract partner with an extensively validated portable gait analysis system that enables US to recruit participants in a decentralized format, coordinating our data acquisition to coincide with CMT clinic days at massachusetts general hospital and other CMT centers of excellence. Our experience extracting actionable design insights from end-user interviews will ensure that our commercial-ready flyband-peds will meet the needs of american families. Gathering our primary endpoints of TOE clearance and gait speed will enable US to evaluate flyband-peds performance, establish its effect size, and design an appropriately powered future phase II clinical study. Because the exoskeleton is hidden within high-top shoes, our production strategy allows US to decrease costs by leveraging footwear manufacturing scale and supply chains. As a class 1 medical device, flyband-peds does not require a 510(k) and may be sold direct-to-consumer and also through reimbursement to ensure that families have broad accessibility which is critical for children who routinely outgrow their footwear and braces. In the long term, flyband-peds will present an accessible alternative to bracing, enabling earlier intervention in disease progression with the aim of reducing compensatory gait and maintaining resilience across the lifespan.