Digital assessment of motor skills in infants and young boys with duchenne muscular dystrophy using wearable sensors

The National Institute of Arthritis and Musculoskeletal and Skin Diseases awarded Biosensics LLC $314,362 under the Arthritis, Musculoskeletal and Skin Diseases Research program (CFDA 93.846) on September 1, 2026, to develop digital assessment tools for motor skills in infants and young boys with Duchenne muscular dystrophy using wearable sensors.

The project addresses a critical clinical gap: current motor assessment methods (Bayley Scales of Infant and Toddler Development) cannot detect functional, real-world motor adaptations outside the clinic and cannot serve as outcome measures in clinical trials, effectively excluding infants and toddlers with DMD from cutting-edge clinical trial participation. The work will create an objective, burden-minimal assessment approach that enables earlier detection of clinically meaningful motor changes in children ages 0–4, supporting earlier initiation of disease-modifying therapies that preserve skeletal health and improve quality of life. The award runs through August 31, 2027, with performance based in Newtonville, Massachusetts. This is a Project Grant, a standard NIAMS assistance vehicle for targeted research development.

Abstract

Duchenne muscular dystrophy (DMD) - the most common inherited x-linked neuromuscular disease - is a progressive and fatal muscle-wasting disease with an estimated incidence of about 1 in 3,500 live male births worldwide. The lack of dystrophin protein results in skeletal muscle wasting and replacement with fibrotic tissue, which begins in utero and continues after birth. These pathophysiological processes result in delay in achieving motor milestones, and motor weakness can be detected during early childhood. While all disease-modifying therapies are recommended to commence at 4 years of age at this time, key DMD stakeholders unanimously agree that beginning treatment at the earliest time will better preserve skeletal health and increase longevity. Unbiased and quantitative assessment of motor abilities in infants and toddlers is paramount, not only because IT is an integral part of their clinical care, but also because IT provides the earliest "treatment" window to begin disease-modifying therapies, which can greatly improve quality-of-life. A major barrier to commencing treatment in infants and young boys (ages 0 - 4 years) with DMD is we lack the ability to detect and continuously assess clinically meaningful, functional motor adaptations objectively and with minimal burden to study participants. Some of the methodological limitations of bayley scales of infant and toddler development (bayley-III), the current used assessment, include that IT cannot detect ecologically meaningful functional "real-world" adaptations as IT can only be administered in the clinic by a qualified professional. This lack of ecological relevance means that IT cannot be considered as a potential clinical outcome measure in future clinical trials, thereby excluding this demographic age group from cutting-edge clinical trials. Bayley-III assessment also may take ~ 2 hours of testing time, a length of time, which can be physically exhausting for infants and toddlers. In this phase i sttr project, we propose pamsys™, a state-of-the-art, patented, FDA-listed wearable sensor, that can detect posture, torso/limb kinematics, as a sensitive and objective tool that overcome methodological limitations of bayley-III. Wearable sensors are unobtrusive, offer flexible evaluation of abilities in both clinical setting and in a naturalistic environment (home/daycare). First, we will test the clinical validity of pamsys™ kinematic data to quantitate the differences in motor abilities in DMD study participants (ages 0 to < 4 years), compared to age-matched neurotypical males (AIM1). Second, we will evaluate the ecological validity of pamsys™-derived measures to detect the person-centered functional adaptations in a naturalistic environment (aim 2). Last, we will conduct online focus group meeting with parents of study participants, representatives from patient advocacy groups and federal representatives, using the technology acceptance model (TAM) to understand the perception of benefit, technology acceptance and anxiety, and attitude of use.