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This funding opportunity announcement (FOA) issued by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH) invites SBIR Phase I applications to design, build, and test novel orthotics that capitalize on the plasticity of the neuromuscular and skeletal systems in growing children to reduce musculoskeletal abnormalities and improve function in children with disabilities.  Applicants are expected to use state-of-the-art biomechanical modeling and materials to revolutionize the field of orthotics for pediatric populations (birth through 21 years of age). 
 

Abnormalities in musculoskeletal development are common in children with disabilities, such as cerebral palsy and spina bifida, and represent a significant and growing proportion of the burden of disability in the U.S. These abnormalities include impaired muscle tone and decreased voluntary muscle contraction, which can limit weight-bearing activities and contribute to the development of contractures and distortions of skeletal geometry, e.g. scoliosis.  Orthotics are the most commonly prescribed medical device for children with a wide range of developmental, orthopedic, and neurological conditions (i.e., plagiocephaly, scoliosis, cerebral palsy, spina bifida, club foot, Down syndrome, muscular dystrophy, and others). They are used to correct bone alignment, reduce contracture/spasticity, restrict or assist movement, and reduce pain. Unfortunately, as many as 50% of prescribed medical devices are not used in this population because the child outgrows them, refuses to use them, or finds them unhelpful. This number may be partly reflective of the minimal innovation in the clinical orthotics field. Orthotics prescribed today have changed little in the past forty years; they are, in general, esthetically unpleasing, rigid plastic and metal devices that restrict clothing and shoe choices. The clinical orthotics field has seen little of the innovative research that has revolutionized the prosthetics field in recent years. However, advances in material science, sensor technology, actuation, and rapid prototyping makes reinvigorating the orthotics field a possibility today. In parallel with these hardware technology developments, the last twenty years has brought advances in musculoskeletal modeling and computational power which allows for subject-specific models with individual variation in skeletal geometries to be created. This may be of particular importance given that orthotics are largely used in conjunction with other therapies, including botulinum toxin type A injections, physical and occupational therapy, and surgical interventions. These models may be used to inform the design of next generation orthotics to capitalize on the plasticity of the developing nervous and musculoskeletal systems while accounting for some of these other variables.

This FOA addresses two themes from the NICHD Scientific Vision: ameliorating childhood disabilities and the role of plasticity in both the nervous and musculoskeletal systems in developing therapies. Moreover, the NIH Blue Ribbon Panel on Medical Rehabilitation in their June 7, 2012 presentation to the National Advisory Child Health and Human Development Council highlighted musculoskeletal rehabilitation as an area where the National Center for Medical Rehabilitation Research (NCMRR) at NICHD should place a larger focus.

NICHD invites Phase I SBIR applications that incorporate appropriate input from developmental pediatricians, physical and occupational therapists, orthotists, materials scientists, and/or engineers to use state-of-the-art materials, manufacturing, and modeling techniques to design, build, and test novel orthotics to promote improved musculoskeletal development in children with disabilities. Innovations may lie in the materials, design, fabrication, use or other aspects of the orthoses; however the goal of these orthotics should be to improve function in activities of daily living.

Areas of interest include but are not limited to:

• Orthotics for lower limb, upper limb, head, neck, or trunk.
• Use of smart textiles and materials, in particular those with increased transparency, comfort, adaptability, and flexibility.
• Use of advanced fabrication technology, including rapid prototyping, 3-D printing, etc. 
• Orthotics may treat existing structural or functional abnormalities, or may act to prevent the occurrence of secondary abnormalities. Designs should account for and promote healthy growth of the child.
• Designs may be passive or active, but should be appropriate to the needs being addressed.
• Modular or component based designs, where appropriate, are encouraged.
• Specific diagnoses include but are not limited to: plagiocephaly, scoliosis, cerebral palsy, spina bifida, club foot, muscular dystrophy, and Down syndrome.
• Specific impairments include but are not limited to: bone deformation and alignment, hypertonia (spasticity), hypotonia (weakness), paralysis, and pain.

While NICHD through NCMRR is committed to prosthetics research and continues to accept applications under the omnibus SBIR solicitation, applications for prosthetics are not applicable for this FOA.