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Orthotics

Orthotics is the branch of healthcare that involves the science and practice of evaluating, measuring, designing, fabricating, assembling, fitting, adjusting, and servicing orthoses—custom-fabricated or custom-fitted medical devices designed to support, align, prevent, or correct deformities and dysfunctions in the neuromuscular and musculoskeletal systems.^[1]^[2] These devices, also known as braces or splints, limit or assist motion in specific body segments, stabilize weakened parts, and enhance overall function for individuals with conditions such as injuries, arthritis, neurological disorders, or congenital deformities.^[3]^[4] The origins of orthotics trace back to ancient civilizations, where rudimentary splints and supports were used to treat fractures and deformities, with archaeological evidence from ancient Egypt including wooden splints used on a fractured femur of a mummy dating to circa 2750 BC. Significant advancements occurred during the 19th and 20th centuries, driven by wartime needs and epidemics like polio; for instance, the invention of the Thomas splint in 1876 revolutionized lower limb treatment.^[5] The modern era of orthotics emerged in the early 1970s, transitioning from craft-based methods to a clinical specialty incorporating advanced materials like plastics, carbon fiber, and lightweight metals, alongside evidence-based designs to improve patient outcomes.^[6]^[7] Orthotic devices are classified by rigidity and anatomical application: soft orthotics provide cushioning and pressure relief using materials like foam or gel, ideal for diabetic foot care or ulcer prevention; semi-rigid orthotics offer moderate support with plastics or composites to control motion in conditions like plantar fasciitis; and rigid orthotics use durable materials such as carbon fiber for structural correction in severe deformities.^[8] By body region, common types include foot orthoses (insoles for alignment), ankle-foot orthoses (AFOs for stability post-stroke), knee-ankle-foot orthoses (KAFOs for lower limb weakness), spinal orthoses (braces for scoliosis), and upper limb orthoses (splints for wrist or elbow support).^[9] Applications span rehabilitation, pain management, and preventive care, reducing injury risk in athletes, improving gait in neurological patients, and mitigating arthritis progression by redistributing biomechanical stresses.^[4]^[10] Orthotics are provided by certified orthotists, healthcare professionals trained through graduate programs combining clinical evaluation, biomechanics, and fabrication techniques, often working in multidisciplinary teams with physicians and physical therapists.^[11]^[12] Recent innovations, including 3D printing and smart sensors for real-time adjustments, continue to enhance efficacy, with ongoing research emphasizing personalized, evidence-based interventions to optimize mobility and quality of life.^[13]

Fundamentals

Definition and Scope

Orthotics are medical devices designed to support, align, prevent, or correct musculoskeletal deformities and abnormalities, thereby enhancing bodily function and mobility.^[14] The term derives from the Greek "ortho," meaning "straight" or "correct," combined with the suffix "-tic," indicating something pertaining to, reflecting their role in straightening or aligning body structures.^[15] These external appliances, often rigid or semi-rigid, address weaknesses or deformities in body parts such as limbs, the spine, or joints, and are applied to manage conditions ranging from congenital issues to acquired injuries.^[16] The primary purposes of orthotics include biomechanical correction to optimize movement patterns, pain relief through load distribution and joint stabilization, injury prevention by mitigating abnormal stresses on tissues, and support for rehabilitation to facilitate recovery and restore function.^[17]^[18] For instance, they can redistribute forces during weight-bearing activities to reduce strain on vulnerable areas, thereby alleviating discomfort and promoting healing in therapeutic contexts.^[19] Orthotics differ from prosthetics, which replace absent or surgically removed body parts such as limbs, whereas orthotics provide supplementary support to existing anatomy without substitution.^[11] They also extend beyond simple footwear inserts, which primarily offer cushioning for the feet, by encompassing devices for the entire body, including upper limbs, torso, and neck.^[8] Key concepts in orthotics include static orthoses, which immobilize or support without permitting motion across affected joints, and dynamic orthoses, which allow or assist with movement to encourage flexibility and function.^[20] Additionally, orthotics are categorized as custom-fabricated for precise individual fit based on assessments or off-the-shelf prefabricated options for general use.^[21] Common examples include braces for spinal alignment, splints for joint protection, and insoles for foot support.^[22]

Historical Development

The origins of orthotics trace back to ancient civilizations, where early forms of supportive devices were crafted from available materials to aid mobility and correct deformities. In ancient Egypt, around 2400 BCE, supportive footwear and prosthetic-like aids made from leather were used, as depicted in hieroglyphics and evidenced by archaeological finds such as wooden and leather toes attached to mummified remains dating to approximately 1000 BCE. Similarly, Greek physicians like Hippocrates described the use of metal and leather supports for limb stabilization in the 5th century BCE, marking some of the earliest documented applications of orthotic principles.^[23]^[24]^[25] During the medieval period, significant advancements emerged in Europe, particularly through the work of French surgeon Ambroise Paré in the 16th century. Paré, often regarded as the father of modern orthotics, developed iron braces and corsets to treat spinal deformities like scoliosis, incorporating perforated designs for breathability and adjustability; these devices were detailed in his 1575 writings and represented a shift toward more structured metal supports for long-term use.^[26]^[27] The 19th and 20th centuries brought further innovations driven by medical and material progress. In the 1850s, Dutch military surgeon Anthonius Mathijsen introduced plaster of Paris casts by impregnating linen bandages with gypsum, revolutionizing immobilization for fractures and deformities during conflicts like the Crimean War. Post-World War II, the adoption of rubber components for cushioning and early plastics like thermoplastics in the 1960s enabled lighter, more flexible orthoses, such as ankle-foot designs, improving patient comfort and functionality. Professional standardization also advanced in the 1950s, with the American Board for Certification in Orthotics, Prosthetics & Pedorthics issuing the first orthotist certifications in 1951 to ensure practitioner competency. The polio epidemics of the mid-20th century, peaking in the 1950s, spurred widespread use of leather-and-steel leg braces to support weakened limbs, affecting thousands and highlighting the need for durable lower-limb orthotics.^[28]^[29]^[30]^[26] In the post-2000 era, digital technologies transformed orthotic fabrication. Computer-aided design and manufacturing (CAD/CAM) systems, first explored in the 1980s but widely integrated after 2000, allowed for precise scanning and customization of devices, reducing production time and improving fit accuracy. The 2010s marked the advent of 3D printing for orthoses, with early clinical applications around 2010 enabling rapid prototyping of custom supports using additive manufacturing techniques. These developments have been influenced by demographic shifts, including aging populations, driving market growth; the global prosthetics and orthotics sector, valued at approximately USD 6.56 billion in 2024, is projected to expand due to increased demand for mobility aids among the elderly.^[31]^[32]^[33]

Professionals and Processes

Role of Orthotists

An orthotist is a healthcare professional specifically educated and trained to assess, design, fabricate, fit, and manage orthotic devices to address musculoskeletal and neuromuscular impairments. In the United States, certification is typically obtained through organizations such as the American Board for Certification in Orthotics, Prosthetics & Pedorthics (ABC) or the Board of Certification/Accreditation (BOC), which ensure practitioners meet standardized competencies in orthotic patient care without differences in core tasks or duties between the two bodies. Internationally, the International Society for Prosthetics and Orthotics (ISPO) recognizes Category I practitioners as fully qualified for independent clinical practice in orthotics.^[34]^[35]^[36] Training to become an orthotist generally requires a bachelor's degree in orthotics and prosthetics or a related field, followed by a specialized master's degree and a one-year residency program accredited by the National Commission on Orthotic and Prosthetic Education (NCOPE). The residency provides hands-on clinical experience in orthotic management, preparing candidates for certification exams administered by ABC or BOC. Under ISPO standards, Category I training equates to a bachelor's-level education with integrated clinical components, enabling full-scope practice globally.^[37]^[38]^[39] Orthotists play a central role in patient care by conducting comprehensive evaluations, including medical history reviews, physical examinations, and gait analyses to determine functional needs and orthotic suitability. They collaborate closely with physicians and rehabilitation teams to develop customized treatment plans, fabricate or select appropriate devices, and perform fittings to optimize outcomes. Ongoing responsibilities include patient education on device use, monitoring progress through follow-up visits, and making adjustments to ensure efficacy and comfort.^[40]^[41]^[42]^[43] Ethical practice is fundamental to the profession, guided by codes such as the ABC Code of Professional Responsibility, which mandates orthotists to prioritize patient needs, document medical necessity for treatments, and use reasonable efforts to promote adherence through education and supportive care. This includes avoiding over-prescription by ensuring orthoses are justified by clinical evidence and patient goals, thereby fostering trust and compliance while preventing unnecessary interventions. In humanitarian and global contexts, ISPO-aligned guidelines further emphasize equitable access and culturally sensitive care to enhance patient engagement.^[44]^[45]^[46] Recent developments underscore the profession's value, as the 2025 Medicare Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) fee schedule implements a 2.4% net increase for non-competitive bidding orthotic services, reflecting adjustments for inflation and productivity to support clinical delivery.^[47]^[48]

Prescription and Fitting

The prescription of orthotics begins with a comprehensive initial assessment, including a detailed physical examination, gait analysis, and review of the patient's medical history to identify functional impairments and biomechanical issues.^[8] Imaging such as X-rays or MRI may be employed if underlying structural abnormalities, like fractures or joint instability, are suspected, ensuring the prescription addresses specific pathologies.^[49] Goal-setting follows, where clinicians collaborate with the patient to define objectives, such as enhancing stability for balance disorders or promoting mobility for ambulatory limitations, tailored to the individual's vocational and daily activity demands.^[50] Device selection then occurs, choosing between prefabricated or custom orthotics based on the assessment, with custom options preferred for complex deformities requiring precise biomechanical correction.^[51] The fitting process commences post-prescription with capturing the patient's anatomy through casting, digital scanning, or foam impressions to create a mold that replicates the foot or limb contours accurately.^[49] During fabrication, adjustments are made to align with therapeutic goals, followed by a trial wear session where the orthotist evaluates fit, comfort, and function, making iterative modifications such as padding additions or strap tensions to prevent pressure points.^[52] Patients receive instructions on proper donning, doffing, and wear schedules, with follow-up visits to refine the device for optimal efficacy and to monitor skin integrity.^[53] Outcomes of orthotic prescriptions are evaluated using standardized metrics to quantify improvements in function and quality of life, such as the Functional Independence Measure (FIM), which assesses independence in daily activities on a 7-point scale across motor and cognitive domains.^[54] Other common tools include the 10-Metre Walk Test for gait speed and the Physiological Cost Index for energy expenditure, which have demonstrated large effect sizes in clinical studies of lower limb orthoses.^[55] These measures guide adjustments and long-term monitoring, ensuring the orthotic meets patient-specific goals.^[56] Common challenges in orthotic prescription and fitting include patient non-compliance, often due to discomfort, ill fit, or inconvenience, which can be mitigated through targeted education on benefits, wear protocols, and troubleshooting.^[57] Contraindications encompass skin allergies to materials like latex or metals, which may provoke contact dermatitis, necessitating alternative hypoallergenic components or pre-use patch testing.^[58] Additional barriers involve functional mismatches or skin irritation from friction, addressed via customized designs and regular follow-ups to enhance adherence rates.^[59] Regulatory oversight for orthotics in the United States falls under the FDA, with most devices classified as Class I, exempt from premarket notification, including simple insoles (product code QMA) intended for general support.^[60] Custom braces and more complex orthoses, such as ankle-foot devices, are typically Class I or II with special controls to ensure safety and effectiveness, as outlined in 21 CFR Part 888, with no substantive classification changes reported in 2025 guidelines.^[61] Compliance with these regulations mandates proper labeling, adverse event reporting, and quality system adherence during prescription and fitting.^[62]

Classification Systems

Functional Categories

Orthotics are classified into functional categories based on their primary biomechanical roles, which determine how they interact with the body to achieve therapeutic outcomes such as immobilization, motion facilitation, load reduction, or injury prevention.^[9] This approach emphasizes the device's purpose in supporting or correcting movement patterns, distinct from anatomical or material-based groupings.^[63] Static orthoses are designed to immobilize joints or body segments, preventing motion to promote healing or stability. These devices lack moving parts and apply rigid support to maintain a fixed position, commonly used in scenarios requiring rest for tissues, such as splints for fracture healing where bone alignment must be preserved during recovery.^[9] By restricting all movement across the targeted joint, static orthoses reduce stress on injured structures and facilitate controlled recovery phases.^[64] Dynamic orthoses, in contrast, permit controlled motion while providing assistance or resistance, enabling functional activities without complete immobilization. Incorporating elements like springs, elastic bands, or hinges, these devices support natural biomechanics during tasks such as walking; for instance, spring-loaded ankle-foot orthoses aid in gait training by assisting dorsiflexion in individuals with weakened muscles.^[9] This category enhances patient engagement in rehabilitation by balancing support with mobility, often improving outcomes in neuromuscular conditions through gradual motion restoration.^[64] Relief orthoses focus on reducing mechanical load or pressure on specific tissues to alleviate pain or prevent further damage, redistributing forces away from vulnerable areas. Materials like polyurethane foams or custom-molded inserts are employed to offload weight, as seen in total contact orthoses for ulcer healing that minimize shear and peak pressures on the plantar surface.^[65] These devices prioritize comfort and tissue preservation, with studies showing reductions in peak plantar pressures in high-risk populations when using accommodative designs.^[65] Prophylactic orthoses aim to prevent injuries by enhancing joint stability and absorbing impact during high-risk activities, particularly in athletic contexts. Functional knee braces, for example, limit excessive valgus loading to reduce the incidence of medial collateral ligament strains in contact sports, with some studies reporting relative risk reductions of up to 58% in knee ligament injuries among braced athletes compared to controls.^[66] These orthoses provide external reinforcement without impeding performance, making them essential for injury risk mitigation in dynamic environments, though overall evidence remains mixed.^[66] The classification of orthotics by function has evolved significantly since the 1970s, transitioning from craft-based descriptive systems developed by organizations like the International Society for Prosthetics and Orthotics (ISPO) to standardized international frameworks. Early ISPO efforts laid groundwork for global consistency.^[67] By the 1980s and 1990s, these were formalized into ISO standards, including ISO 8549 for terminology^[68] and ISO 9999 for assistive product classification, emphasizing biomechanical roles.^[69] Modern iterations, such as ISO 13404-1 (2024) for lower limb orthoses^[70] and ISO 22523 for requirements and test methods for external orthoses,^[71] incorporate rigorous performance metrics to ensure devices meet clinical efficacy through load-bearing and motion analysis protocols. This progression has enhanced interoperability, quality assurance, and evidence-based prescribing in orthotics practice.

Anatomical Classifications

Orthotics are classified anatomically according to the primary body regions they support, facilitating targeted interventions for region-specific impairments while bridging to more detailed functional and manufacturing considerations. This approach organizes devices by anatomical location, such as the lower limbs, upper limbs, spine, cranium, and hybrid systems spanning multiple areas, to address localized biomechanical needs like stability, alignment, or protection.^[72]^[73] Lower limb orthotics primarily emphasize weight-bearing support to enhance gait, balance, and load distribution, often prescribed for conditions involving muscle weakness or joint instability. Ankle-foot orthoses (AFOs), for instance, represent a key example; in a study of stroke patients, AFOs were prescribed to approximately 43%.^[74] These devices are commonly used, reflecting the high incidence of lower extremity disorders such as osteoarthritis and neurological impairments.^[75]^[33] In contrast, upper limb orthotics prioritize fine motor assistance, supporting precise movements in the hands, wrists, and arms to aid tasks requiring dexterity, such as grasping or manipulation, due to the upper extremities' specialized role in coordinated function.^[20] Spinal orthotics focus on alignment for posture correction, stabilizing the vertebral column to counteract deformities and maintain structural integrity during upright activities. These devices apply corrective forces to the torso, often addressing conditions like kyphosis or early scoliosis progression.^[76] Cranial orthotics, meanwhile, serve dual purposes of protection and shaping, particularly in pediatric applications where custom helmets remodel abnormal skull contours, such as in deformational plagiocephaly, by guiding natural growth patterns.^[77] Hybrid systems integrate support across multiple anatomical regions in full-body orthoses, designed for severe, multifaceted conditions like advanced scoliosis, building on foundational designs such as the Milwaukee brace to provide comprehensive stabilization from the cervical spine to the pelvis.^[78]^[79] This classification underscores how anatomical targeting enables orthotics to complement functional roles, such as immobilization or mobility aid, without overlapping into specialized fabrication details.^[80]

Manufacturing Techniques

Design Principles

Orthotic design is fundamentally grounded in biomechanical principles that ensure effective support, stability, and functionality while minimizing adverse effects on the body. Central to this is load distribution, where orthoses are engineered to redistribute forces across anatomical structures to prevent localized pressure points and reduce injury risk; for instance, in lower limb orthoses, forces are balanced to support weight-bearing without overloading joints or soft tissues.^[81] Joint alignment is another core principle, achieved by positioning the orthosis to maintain or correct anatomical axes, often employing three-point pressure systems to control angular motion and stabilize joints like the ankle or knee.^[82] Lever systems further enhance stability by acting as mechanical arms that generate corrective forces, such as in spinal orthoses where pressure equals total force divided by the contact area, allowing precise angular corrections without excessive bulk.^[81] These principles collectively optimize gait, posture, and energy efficiency, drawing from musculoskeletal biomechanics to mimic natural joint mechanics.^[83] Customization methods in orthotic design prioritize patient-specific adaptations to achieve optimal fit and performance. Traditional plaster casting captures detailed anatomical contours by molding wet plaster directly onto the body segment, providing a precise negative impression for fabrication, though it can be time-intensive and uncomfortable.^[84] Digital scanning has emerged as a non-invasive alternative, using 3D laser or photogrammetry techniques to generate accurate surface models in minutes, enabling virtual modifications before production.^[85] Advanced simulations, such as finite element analysis (FEA), further refine designs by modeling stress distribution and deformation under simulated loads, predicting potential failure points and ensuring biomechanical compatibility without physical prototypes.^[86] These methods integrate to produce orthoses tailored to individual pathologies, such as varus alignment corrections in ankle-foot orthoses. Quality standards ensure orthotic safety and reliability, with ISO 10993-1 serving as the primary framework for biocompatibility evaluation of medical devices, including orthotics, by assessing cytotoxicity, sensitization, and irritation risks based on contact duration and material composition.^[87] For external orthoses, this involves risk-based testing to confirm non-toxicity and tissue compatibility, particularly for skin-contacting devices.^[88] Durability testing complements this by subjecting dynamic orthoses to cyclic fatigue protocols under regulatory requirements like those in 21 CFR Part 890, simulating extended use to ensure structural integrity.^[89] These standards, enforced through regulatory bodies like the FDA, guarantee that orthoses withstand mechanical demands while posing minimal biological risks. Iterative design processes incorporate prototyping and patient feedback to refine orthotic efficacy. Initial prototypes, often created via 3D printing from digital scans, allow for rapid physical testing and adjustments based on wear trials, where patients provide input on comfort, fit, and functional limitations.^[90] This feedback loop enables sequential modifications, such as altering leverage points or padding, to better align with biomechanical goals and user needs, reducing revision rates and enhancing long-term adherence.^[91] As of 2025, artificial intelligence (AI) tools are increasingly incorporated into CAD software to predict stress distributions and optimize designs for individual anatomies, further enhancing personalization.^[13] For example, certain integrations of computer-aided design (CAD) software with 3D printing, such as LutraCAD with Raise3D printers, have been reported to reduce production times by approximately 50% compared to traditional methods, streamlining orthotic production through automated modeling and simulation tools that eliminate manual drafting errors and accelerate customization workflows.^[92]

Materials and Fabrication Methods

Orthotics are fabricated using a range of materials selected for their mechanical properties, biocompatibility, and suitability for patient-specific applications. Thermoplastics, such as polypropylene, are widely employed for their rigidity and ability to be molded into supportive structures, providing the necessary stiffness for lower limb orthoses while maintaining flexibility under load.^[93]^[94] Composites like carbon fiber reinforced polymers offer lightweight strength and enhanced energy return, increasingly adopted in dynamic orthoses; for instance, materials such as ProComp®, which infuses carbon fibers between polypropylene layers, improve stiffness without adding significant weight, contributing to a growing market segment projected at $500 million in 2025.^[95]^[96] Soft materials, including ethylene-vinyl acetate (EVA) foams and Poron polyurethane, serve as padding and cushioning layers to distribute pressure and enhance comfort during prolonged wear.^[93]^[97] Fabrication methods for orthotics balance precision, customization, and efficiency. Traditional thermoforming involves heating thermoplastic sheets and vacuum-forming them over positive casts of the patient's anatomy, a cost-effective technique valued for its simplicity and scalability in producing rigid shells.^[98] Additive manufacturing via 3D printing enables direct production from digital scans, allowing for complex geometries and patient-specific designs like custom insoles, with material waste reduced to less than 5% compared to subtractive processes.^[99]^[100] CNC milling, a subtractive method, carves orthotic components from solid blocks of material such as foams or composites, offering high precision for prototypes but generating more waste than 3D printing.^[101] Metals like aluminum or titanium are occasionally used in durable components for their strength, though their added weight can compromise wearability, while silicone interfaces provide hypoallergenic skin contact to prevent irritation.^[102] Sustainability trends in orthotics fabrication have gained momentum since 2020, with the emergence of recyclable bioplastics and biodegradable alternatives aimed at reducing environmental impact from disposable devices. These materials, including plant-based polymers, are being integrated into liners and supports to facilitate end-of-life recycling, aligning with broader efforts in medical equipment to minimize plastic waste.^[103]^[104] Cost considerations vary significantly by production approach: off-the-shelf orthotics typically range from $50 to $200, leveraging standardized thermoforming for affordability, whereas custom-fabricated devices, often involving 3D printing or CNC milling, cost $500 to $3,000 due to labor-intensive personalization and advanced materials.^[105]^[106]^[107]

Lower Limb Orthoses

Orthoses for Paralysis and Neuromuscular Conditions

Orthoses for paralysis and neuromuscular conditions in the lower limbs are designed to compensate for muscle weakness, spasticity, or loss of motor control, enabling improved mobility and preventing secondary complications such as joint deformities. These devices, including ankle-foot orthoses (AFOs) and more comprehensive systems like hip-knee-ankle-foot orthoses (HKAFOs), support weight-bearing and facilitate gait patterns that mimic natural locomotion.^[108] Assessment begins with muscle strength grading using the Medical Research Council (MRC) scale, which evaluates power from 0 (no contraction) to 5 (normal strength against full resistance). This 0-5 scale helps clinicians determine the extent of paralysis or weakness in key lower limb muscles, such as the tibialis anterior and gastrocnemius, guiding orthosis selection. Gait analysis, often involving observational or instrumented methods, identifies abnormalities like drop foot, characterized by inadequate dorsiflexion during swing phase, leading to toe drag or foot slap. In neuromuscular conditions, this analysis quantifies asymmetries in step length, cadence, and ground reaction forces to tailor orthotic interventions.^[109]^[110] Common types include reciprocating gait orthoses (RGOs), which are HKAFO variants using cable or linkage systems to promote alternating leg movement for individuals with thoracic-level spinal cord injuries (T1-T12). In a multicenter study of 74 patients with complete traumatic spinal cord injuries, RGOs enabled functional gait in 31 participants at six months post-training, with usage influenced by younger age, higher lesion levels, and stair-climbing ability. Hybrid systems combining functional electrical stimulation (FES) with orthoses deliver timed electrical impulses to paralyzed muscles while mechanical bracing provides stability, enhancing standing and walking in paraplegic patients. These FES-orthosis hybrids have shown potential to restore reciprocal gait patterns, though challenges like skin irritation and device weight persist.^[111]^[112] Functional elements such as hinges ensure knee-ankle coordination by locking the knee in extension during stance for stability and allowing flexion in swing for clearance. Automatic hinge mechanisms in leg orthoses achieve this through friction or spring-loaded designs that resist flexion under load but permit free movement otherwise. Carbon fiber struts, often posterior in AFOs, provide energy storage by flexing during mid-stance and releasing stored elastic energy to assist push-off, reducing metabolic cost compared to rigid alternatives.^[113]^[114] These orthoses address conditions like poliomyelitis, multiple sclerosis (MS), and stroke, where lower motor neuron damage or central nervous system lesions impair dorsiflexion and plantarflexion control. For instance, AFOs in polio survivors prevent equinus deformities by maintaining neutral ankle alignment, while in MS and stroke patients, they counteract spasticity-induced plantar flexion contractures that limit range of motion. In stroke cases with mild contractures (under 10 degrees), posterior shell AFOs have been shown to improve dorsiflexion during gait without exacerbating stiffness.^[115] Clinical outcomes demonstrate enhanced mobility, with studies reporting 20-30% increases in walking speed for users of dynamic AFOs or FES hybrids in neuromuscular paralysis.^[116] For example, FES-assisted drop foot systems improved speed by 25% in pilot tests among stroke and SCI patients, alongside gains in step length and cadence.^[116] Overall, these interventions boost energy efficiency and functional independence, though long-term adherence depends on user training and device customization.^[116]^[117]

Relief and Support Orthoses

Relief and support orthoses for the lower limbs primarily aim to alleviate pressure on vulnerable tissues, facilitate wound healing, and stabilize joints under load, particularly in conditions where mobility is preserved but tissue integrity is compromised. These devices distribute weight away from high-pressure areas, such as the plantar surface of the foot or medial knee compartment, using rigid or semi-rigid structures to promote recovery without restricting overall function. Common indications include diabetic foot ulcers, where offloading prevents further tissue breakdown, and post-injury swelling, such as ankle sprains or soft tissue trauma, where support minimizes edema and aids gradual return to weight-bearing. Unlike dynamic orthoses for motor deficits, these focus on protective stabilization for stressed but intact musculoskeletal structures. Key types encompass ulcer healing orthoses like total contact casts (TCCs), which encase the foot and leg to achieve even pressure distribution across the entire plantar surface, reducing peak forces by up to 50% compared to standard footwear. TCCs are a gold standard for neuropathic diabetic foot ulcers, with randomized controlled trials demonstrating healing rates of 70-90% within 6-12 weeks, significantly outperforming removable offloading devices in both speed and completeness of closure. Foot orthoses for arch support, often custom-molded insoles, elevate and cushion the medial longitudinal arch to counteract collapse in flatfoot or pes planus, indicated for chronic arch strain or preventive support in high-risk populations. Systematic reviews indicate limited evidence that these orthoses may reduce foot pain and improve function in adults with flatfoot, though benefits are most pronounced when customized to individual biomechanics.^[118] Ankle-foot orthoses (AFOs) designed for varus or valgus relief incorporate medial or lateral uprights and T-straps to correct angular deformities, thereby unloading the affected ankle compartment during stance phase. These are prescribed for valgus instability post-injury or varus alignment in early osteoarthritis, helping to maintain neutral positioning and reduce joint stress. For the knee, unloader braces apply a three-point force system to shift load from the medial compartment in osteoarthritis, achieving a 10-20% reduction in medial peak pressure and adduction moment, as evidenced by biomechanical studies and randomized trials showing sustained pain relief over 3-6 months. Modular designs in these orthoses, featuring adjustable straps and interchangeable components, allow for progressive weight-bearing protocols, enabling clinicians to incrementally increase support as healing advances and patient tolerance improves.

Soft and Prophylactic Braces

Soft and prophylactic braces represent a category of flexible lower limb orthotics designed primarily for mild support, injury prevention, and early rehabilitation, utilizing materials like neoprene and elastic fabrics to provide compression without significantly impeding natural joint motion.^[119] Common types include neoprene knee sleeves, which encase the knee for warmth and stability; elastic ankle wraps, which offer adjustable compression around the ankle; and prophylactic anterior cruciate ligament (ACL) braces tailored for athletic activities, featuring lightweight hinges or straps to mitigate valgus stresses during dynamic movements.^[120]^[66] These devices are typically available over-the-counter (OTC) in standardized sizes, allowing users to select based on limb circumference measurements for optimal fit, though proper sizing is crucial to avoid slippage or inadequate support.^[121] These braces find primary applications in post-surgical rehabilitation and the prevention of overuse injuries in active populations. In post-ACL reconstruction recovery, neoprene knee sleeves facilitate gradual return to function by enhancing joint awareness and reducing perceived instability during daily activities and light exercises.^[122] For overuse conditions such as shin splints—medial tibial stress syndrome common in runners—soft calf or shin supports provide targeted compression to alleviate periosteal irritation and promote tissue recovery without halting training entirely.^[123] Prophylactic ACL braces are particularly employed in contact sports like football and soccer to safeguard against non-contact ligament strains, while elastic ankle wraps serve as preventive measures for individuals with prior sprains during sports or occupational tasks involving repetitive foot impacts.^[124]^[66] The benefits of these braces center on non-restrictive support that enhances proprioception—the body's sense of joint position—and controls swelling through gentle compression, thereby supporting rehabilitation without the bulk of rigid alternatives. Neoprene sleeves, for instance, improve joint position sense in fatigued states, particularly benefiting those with baseline proprioceptive deficits by providing cutaneous feedback that refines neuromuscular control.^[120] Compression from elastic materials aids edema reduction in post-injury phases, potentially accelerating recovery timelines, while the flexibility preserves range of motion essential for therapeutic exercises.^[122] Evidence from meta-analyses supports their prophylactic value, with bracing and taping reducing ankle sprain incidence by 50-70% in at-risk athletes, attributed to mechanical restriction of excessive inversion.^[125] Similarly, soft orthoses have demonstrated efficacy in lowering tibial stress fracture rates in military recruits by up to 50% through distributed load absorption.^[123] For prophylactic knee bracing in sports, systematic reviews indicate variable but potential reductions in medial collateral ligament injuries by 50% in some cohorts, though results for ACL protection remain inconsistent across studies.^[66] Despite these advantages, soft and prophylactic braces have notable limitations, particularly in addressing severe deformities or high-load scenarios where greater structural control is required. Their compressible materials, such as neoprene, flatten over time with repeated use, diminishing support and necessitating more frequent replacements, making them less suitable for profound misalignments like advanced flatfoot or significant joint instability.^[121] OTC versions rely on user-selected sizing, which may lead to suboptimal fit if limb measurements are imprecise, potentially exacerbating rather than alleviating symptoms in complex cases. Guidelines recommend measuring the affected area at its widest point and consulting sizing charts from manufacturers to ensure efficacy, but professional evaluation is advised for persistent issues.^[121] Overall, these braces excel in preventive and mild rehabilitative roles but should be complemented with targeted exercises for long-term outcomes.

Upper Limb Orthoses

Shoulder and Arm Supports

Shoulder and arm supports encompass a range of orthotic devices aimed at stabilizing the proximal upper limb, particularly the shoulder girdle and humerus, to promote healing, reduce pain, and restore function following injury or pathology. These orthoses typically target the glenohumeral joint and surrounding structures, providing immobilization or controlled motion to address instability or weakness. Unlike distal upper limb devices, they emphasize gross stability for weight-bearing and daily activities, often integrating with broader functional support strategies in rehabilitation. Key types include the figure-of-8 clavicle brace, which encircles the shoulders in a crossed pattern to approximate fractured clavicle ends and maintain alignment during healing. This design is particularly suited for midshaft clavicle fractures, where conservative management is preferred in non-displaced cases. Another prominent type is the shoulder immobilizer, a padded sling-like device that secures the arm against the torso, commonly used for rotator cuff injuries to minimize tension on repaired tendons and prevent re-injury during the acute phase. For conditions involving restricted motion, abduction splints position the arm in slight elevation to counteract adhesions, as seen in adhesive capsulitis. These orthoses serve critical functions such as post-fracture alignment to ensure proper bone union without surgical intervention and abduction support for frozen shoulder to facilitate gradual range-of-motion gains through sustained stretch. In rotator cuff pathology, immobilizers reduce shear forces on the joint, aiding tissue repair while allowing limited pendular exercises to maintain circulation. Overall, they mitigate excessive glenohumeral translation and support scapular positioning to alleviate biomechanical stress. Design features prioritize patient comfort and efficacy, incorporating adjustable Velcro straps for individualized tension and sizing to accommodate swelling fluctuations. Padded axillary interfaces, often made from foam or gel, distribute pressure evenly to prevent nerve compression, skin breakdown, or brachial plexus irritation during prolonged wear. Lightweight thermoplastic or fabric composites enhance compliance by balancing rigidity with breathability. Indications for shoulder and arm supports primarily include traumatic injuries like clavicle fractures and rotator cuff tears, as well as degenerative conditions such as glenohumeral arthritis, where inflammation compromises joint integrity. These devices are frequently prescribed in post-operative scenarios or for non-surgical management of instability, with trauma accounting for a substantial portion of upper limb orthotic applications in clinical practice. Clinical outcomes demonstrate efficacy in pain management and functional recovery; for instance, studies on hemiplegic shoulder pain post-stroke indicate that orthoses significantly reduce subluxation-related discomfort and are well-tolerated with extended use. In adhesive capsulitis trials, abduction splinting combined with stretching yielded notable pain relief and improved abduction range by up to 30 degrees on average, enhancing daily activities without adverse effects. For rotator cuff repairs, immobilizers have shown comparable healing rates to slings while supporting early rehabilitation, with pain scores decreasing in over 50% of patients within weeks.

Hand and Wrist Orthoses

Hand and wrist orthoses encompass a range of devices tailored to immobilize, support, or mobilize the distal upper extremity, addressing conditions that impair grip, dexterity, and comfort. These orthoses are essential for managing inflammatory, traumatic, and neurological disorders by maintaining optimal alignment, reducing pain, and facilitating recovery. Unlike proximal upper limb supports, they emphasize precision in the carpal and metacarpal regions to preserve fine motor function.^[126] Common types include the cock-up splint, which positions the wrist in neutral extension to alleviate median nerve compression in carpal tunnel syndrome (CTS). This design minimizes tunnel pressure during rest or activity, promoting symptom reduction without restricting forearm motion. For rheumatoid arthritis (RA), resting pan splints support the hand in a functional posture—wrist slightly extended, metacarpophalangeal joints flexed, and thumb abducted—to counteract ulnar deviation and prevent joint deformities during inactive periods. These splints are typically worn at night or during flare-ups to manage swelling and stiffness.^[126]^[127]^[128] In terms of functions, thumb spica orthoses immobilize the thumb metacarpal and wrist to treat De Quervain's tenosynovitis, isolating the abductor pollicis longus and extensor pollicis brevis tendons to reduce inflammation and support healing. Dynamic splints, equipped with outriggers and elastic bands, enable controlled extension or flexion following tendon repairs in zones V-VI of the hand, encouraging early active motion while guarding against rupture or adhesions. These functional orthoses balance protection with rehabilitation to optimize long-term outcomes.^[129]^[130]^[131] Fabrication of hand and wrist orthoses often involves thermoplastic molding, where low-temperature materials like Orfit or Aquaplast are heated to 65-75°C and contoured directly onto the patient's limb for a precise, lightweight fit that accommodates individual anatomy. This method ensures biocompatibility and adjustability, with materials selected based on rigidity needs—firmer for immobilization, more resilient for dynamic applications. Static-progressive splints, constructed with adjustable hinges or turnbuckles, deliver serial stretching for contractures by incrementally positioning the wrist or fingers at end-range, typically over 4-6 weeks to regain motion without surgery.^[132]^[133]^[134]^[135] Indications for these orthoses span post-surgical scenarios, such as after carpal tunnel release or tendon grafting, where they protect incisions and promote scar remodeling for 2-4 weeks. In neurological contexts, like stroke-related hemiplegia, static orthoses maintain anti-spastic positioning to prevent flexor synergies and joint shortening, often integrated briefly with arm supports for holistic upper limb care. Soft variants may complement these for prophylactic use in early RA or overuse prevention.^[136]^[137]^[20] Clinical evidence supports their efficacy, particularly for CTS, where night splinting in neutral position yields approximately 70% symptom relief in mild cases, as outlined in 2025 guidelines emphasizing conservative management before escalation. Randomized trials confirm cock-up splints reduce pain and improve function over 4-6 weeks, with moderate evidence from APTA, AAOS, and AAN recommendations. For RA and post-stroke applications, orthoses demonstrate pain mitigation during use, though long-term functional gains vary by compliance and intervention duration.^[138]^[139]^[140]^[127]

Spinal and Thoracic Orthoses

Cervical and Thoracic Supports

Cervical and thoracic supports encompass a range of orthotic devices designed to stabilize the upper spine, addressing trauma-related injuries and postural deformities such as kyphosis. These orthoses primarily target the cervical (neck) and thoracic (upper back) regions to restrict excessive motion, support healing, and maintain alignment following events like whiplash, fractures, or spinal cord injuries. By limiting flexion and extension, they reduce stress on injured tissues and promote natural recovery processes without invasive intervention.^[81]^[141] Common types include the Philadelphia collar for cervical support and thoracic extension braces for upper back conditions. The Philadelphia collar, a rigid orthosis, is widely used for whiplash injuries and stable cervical fractures, providing immobilization to prevent further damage during the acute phase. Thoracic extension braces, such as the Taylor brace, are indicated for kyphosis and vertebral body fractures in the thoracic spine, extending support to the lumbar region when necessary to counteract forward curvature and promote hyperextension. These devices function by constraining rotational, lateral, and anterior-posterior movements, thereby facilitating fracture healing and reducing the risk of non-union in trauma cases.^[81]^[142]^[143] Design features emphasize rigidity and comfort for effective long-term use. Cervical collars like the Philadelphia model typically consist of foam-lined rigid plastics molded into a two-piece structure that encircles the mandible, occiput, and chest, offering adjustable fit through Velcro straps. Thoracic braces often employ four-panel systems with posterior aluminum or plastic stays and anterior sternal supports, allowing customization for body size and progressive weaning as healing advances. These materials provide biomechanical stability while minimizing skin irritation, with semi-rigid variants incorporating breathable fabrics for extended wear in posture correction scenarios. However, prolonged use may lead to muscle weakening or skin issues, necessitating monitoring and combination with physical therapy.^[81]^[144]^[145] Indications for these supports include acute spinal cord injuries, post-operative stabilization after cervical fusion or thoracic procedures, and conservative management of postural kyphosis in older adults. They are particularly beneficial in trauma settings to immobilize unstable segments and in non-traumatic cases to alleviate chronic strain from poor posture. For instance, post-whiplash patients benefit from collars to limit motion and support ligamentous healing, while kyphotic individuals use extension braces to redistribute loads and prevent progression.^[81]^[141]^[146] Clinical outcomes demonstrate benefits in pain management and spinal alignment, though evidence is mixed for some applications. While traditionally used, recent studies suggest rigid cervical collars provide limited benefits for pain and disability in whiplash-associated disorders compared to early mobilization, with mixed evidence on improvements in neck range of motion and posture after 6-12 weeks.^[147] Thoracic orthoses for kyphosis have been associated with reduced thoracic kyphotic angles by up to 10-15 degrees and enhanced back extensor strength, leading to better balance and decreased fall risk in elderly patients. Overall, these devices yield substantial pain relief—often reported as moderate to significant reductions—and improved functional alignment, supporting their role in both acute trauma recovery and chronic posture correction.^[144]^[148]^[149]^[150]

Lumbar and Sacroiliac Orthoses

Lumbar and sacroiliac orthoses are specialized devices designed to provide support and stability to the lower spine and pelvic region, primarily addressing conditions affecting the lumbar vertebrae and sacroiliac joints. These orthoses work by restricting excessive motion, enhancing proprioception, and redistributing mechanical loads to alleviate pain and promote healing. They are commonly prescribed for acute and chronic lower back issues, with lumbosacral corsets and sacroiliac joint belts representing key variants tailored to specific anatomical needs. However, prolonged use may lead to muscle weakening or skin issues, necessitating monitoring and combination with physical therapy.^[141] Lumbosacral corsets, often constructed from elastic fabrics with rigid stays, encircle the lower abdomen and back to limit flexion and rotation while increasing intra-abdominal pressure. This mechanism unloads the intervertebral discs, particularly in cases of disc herniation, by elevating hydrostatic pressure within the abdominal cavity to counter compressive forces on the spine. For instance, these corsets can reduce disc pressure by up to 30-50% during forward bending, supporting conservative management of herniated discs. Sacroiliac joint belts, narrower and positioned around the pelvis, focus on compressing the sacroiliac joints to stabilize the pelvic girdle, especially beneficial for pregnancy-related pain where ligament laxity exacerbates instability.^[151]^[152]^[153] Design features of these orthoses vary by rigidity and application. Hyperextension braces, such as the Jewett orthosis, incorporate anterior and posterior sternal and pubic pads to promote thoracic-lumbar hyperextension, effectively immobilizing the spine in a neutral or extended position. The Jewett brace is particularly suited for stable compression fractures of the thoracolumbar junction, preventing further vertebral collapse by countering flexion forces. In contrast, softer designs like flexible SI belts use adjustable Velcro straps for targeted pelvic compression without restricting overall mobility. These elements ensure biomechanical control while accommodating daily activities.^[154]^[155]^[156] Indications for lumbar and sacroiliac orthoses include sciatica associated with lumbar radiculopathy, where they reduce nerve root irritation through postural support, and osteoporosis-related vertebral compression fractures, aiding in pain control and fracture stabilization. They are also indicated for sacroiliac joint dysfunction, including pregnancy-induced pelvic girdle pain, affecting 20-70% of pregnant individuals, depending on diagnostic criteria.^[144]^[157]^[158]^[159] Evidence from recent systematic reviews supports short-term benefits, with lumbar orthoses providing pain relief of up to 50% in acute low back pain episodes and improving functional outcomes like mobility within 4-6 weeks. For SI belts, randomized trials show potential reductions in pregnancy-related pelvic pain intensity, though evidence is mixed and long-term benefits are unclear. However, long-term efficacy remains limited, as recent reviews (as of 2024) indicate no significant prevention of pain recurrence beyond 6 months and potential muscle weakening with prolonged use, emphasizing their role as adjuncts to physical therapy rather than standalone treatments.^[160]^[161]^[153]^[162]

Cranial and Head Orthoses

Helmet Therapy for Deformities

Helmet therapy, also known as cranial orthosis or molding helmet therapy, is a non-invasive treatment primarily used to correct deformational plagiocephaly and other positional cranial asymmetries in infants, where the skull develops a flattened or asymmetrical shape due to prolonged pressure on one area during early development.^[163] This condition affects up to 1 in 5 infants and is distinct from craniosynostosis, as it results from external forces rather than premature suture fusion.^[164] The therapy leverages the rapid skull growth in infants under 12 months, applying gentle, targeted pressure to redirect bone development toward a more symmetrical shape.^[77] Two main types of devices are employed: custom-molded helmets and dynamic orthotic bands. Custom-molded helmets, such as cranial remolding orthoses (CROs), are fabricated from lightweight plastics like polypropylene and are precisely shaped using 3D scans of the infant's head to create openings that allow growth in flattened areas while restricting expansion elsewhere.^[165] Dynamic bands, exemplified by the Dynamic Orthotic Cranioplasty (DOC) Band, are adjustable, semi-rigid devices made from materials like polyethylene that apply corrective forces through tension straps, making them suitable for moderate cases where less intensive molding is needed.^[166] Both types are prescribed after initial conservative measures, such as repositioning and tummy time, fail to resolve moderate to severe asymmetry, as recommended by the Congress of Neurological Surgeons (CNS).^[167] The treatment process typically begins with a clinical assessment between 4 and 6 months of age, when skull growth is most malleable, involving 3D scanning or plaster casting to capture the head's contours for device customization.^[168] The orthosis is then fitted, and the infant wears it for 23 hours per day—removable only for bathing and cleaning—for a duration of 3 to 6 months, depending on the severity of the deformity and response to therapy.^[169] Progress is monitored through regular clinic visits, often biweekly, to adjust fit as the head grows and ensure optimal pressure distribution.^[170] AAP guidance emphasizes early intervention to maximize outcomes, with studies showing significant head shape improvements when initiated before 6 months.^[171] For instance, one cohort achieved a mean reduction in cranial vault asymmetry index (CVAI) from 9.8% to 5.4% post-treatment.^[172] However, the efficacy of helmet therapy remains debated, with some randomized controlled trials finding no significant advantage over conservative repositioning alone.^[173] While generally safe, helmet therapy carries risks primarily related to skin health, including irritation, redness, or minor pressure sores in up to 96% of users due to prolonged contact and moisture buildup.^[174] These issues are mitigated through daily cleaning with mild soap, barrier creams, and vigilant monitoring during adjustment visits every two weeks to prevent escalation.^[175] No serious complications like infections or growth restriction have been widely reported in clinical reviews.^[176] As of 2025, advancements in materials have introduced lightweight composites and 3D-printed designs, which enhance comfort and compliance for extended wear compared to traditional models.^[177] These innovations, including improved ventilation and customizable semi-rigid elements, are increasingly adopted for milder cases, building on established protocols while minimizing discomfort.^[178]

Protective Head Gear

Protective head gear in orthotics encompasses non-therapeutic devices designed primarily to prevent injuries from external impacts or falls, rather than to correct deformities. These include rigid helmets for high-risk occupational and recreational activities, as well as softer alternatives for medical vulnerability. Common types feature hard-shell helmets for cyclists, which typically consist of a polycarbonate outer shell with internal foam liners to absorb shock during collisions, and similar designs for construction workers, where reinforced hard hats protect against falling objects and overhead hazards. For individuals with conditions like epilepsy, soft caps or padded helmets provide cushioning during seizures to minimize head trauma from sudden falls, often using flexible materials like polyethylene foam for comfort and full coverage including the chin and ears.^[179]^[180]^[181] Performance standards ensure these devices meet minimum safety thresholds, with ASTM F1446 outlining test methods for impact resistance, including drop tests to measure acceleration limits on an instrumented headform. Padding materials, such as expanded polystyrene (EPS) foam, are integral to energy absorption; upon impact, the foam deforms to dissipate force, significantly reducing transmitted acceleration to the head in controlled tests. In applications like sports, such helmets have demonstrated significant efficacy, with a Norwegian case-control study finding that bicycle helmet use reduced the risk of head injuries by 60%, including concussions from rotational and linear forces. Medically, post-craniotomy shields—custom or adjustable padded helmets—protect surgical sites during recovery, allowing safe mobility while preventing secondary impacts that could compromise healing.^[182]^[183]^[184] Despite these benefits, protective head gear faces limitations that can affect usability. Heat buildup is a primary concern, as enclosed designs trap body heat and reduce airflow, leading to discomfort, fatigue, and headaches during prolonged wear in warm environments, with studies showing notable temperature increases inside non-ventilated helmets. Compliance issues are particularly pronounced in children, where poor fit or perceived discomfort results in inconsistent use; one analysis of U.S. bicycle accidents revealed that over 80% of involved children were unhelmeted, often due to social and fitting barriers. Regulations aim to mitigate such drawbacks, with the U.S. Consumer Product Safety Commission (CPSC) enforcing its bicycle helmet standard to include impact and retention requirements, while industry trends incorporate ventilation features in certified designs to enhance comfort without compromising protection.^[185]^[186]^[179]

Emerging Applications

Technological Advances

Recent advancements in 3D printing have revolutionized orthotics by enabling on-demand custom production, allowing for rapid fabrication of personalized devices directly from digital scans. This technology facilitates the creation of intricate, patient-specific designs that traditional methods cannot achieve as efficiently, reducing production times from weeks to hours. For instance, 3D printing has been shown to cut production costs by 60-70% through minimized material waste and labor, making orthotics more accessible.^[187] Smart orthotics integrate embedded sensors to provide real-time gait monitoring, enhancing user feedback and clinical oversight. These devices, such as ankle-foot orthoses (AFOs) equipped with inertial measurement units, transmit data on ankle angles and moments wirelessly to mobile applications, allowing orthotists to adjust treatments dynamically. Examples include the Smart AFO system, which streams sagittal plane gait metrics in real time via Bluetooth, supporting remote monitoring for conditions like drop foot. IoT-enabled smart orthoses further enable continuous tracking of movement patterns, improving adherence and outcomes in rehabilitation.^[188]^[189]^[190] Robotic exoskeletons represent a major leap in powered orthotic systems, particularly for individuals with paralysis, by providing motorized assistance for ambulation. The ReWalk Personal Exoskeleton, first approved by the FDA in 2014 for spinal cord injury patients, enables standing and walking through hip and knee actuation controlled by body shifts. In 2025, the ReWalk 7 Personal Exoskeleton received FDA clearance and began sales, featuring improved battery life and cloud connectivity for better user experience. Prototypes, such as those demonstrated by ReWalk in 2023, incorporate AI for autonomous decision-making including terrain detection and adaptive gait modulation. Ongoing developments aim to enhance safety and natural movement in real-world settings, with clinical trials showing improved mobility metrics.^[191]^[192]^[193] Artificial intelligence is transforming orthotic design through predictive modeling, which analyzes patient data like scans and biomechanics to generate personalized fits. AI algorithms process 3D foot models and gait patterns to optimize device geometry, ensuring precise alignment and comfort without extensive trial-and-error. Platforms like Footprint.AI use smartphone-based assessments to create custom orthotics in minutes, leveraging machine learning for predictive sizing and material selection. This approach has been applied in wrist splints and lower limb devices, where AI from single-image inputs predicts fitting parameters with high accuracy.^[194]^[195]^[196] The orthotics sector is experiencing significant market growth, projected to reach USD 13.3 billion by 2035, fueled by innovations in composite materials and tele-rehabilitation integration. Advanced composites enhance device lightness and durability, while tele-rehab platforms allow remote adjustments via sensor data, expanding access in underserved areas. This expansion reflects a compound annual growth rate of approximately 5.7% from 2025 onward, driven by rising demand for personalized and tech-enabled solutions.^[197]^[198]^[199]

Specialized Uses in Sports and Pediatrics

In sports, custom orthotic insoles are widely used by runners to mitigate impact forces during high-intensity activities. Thermoplastic polyurethane (TPU) custom foot orthoses have been shown to reduce vertical loading rates by approximately 12% at both low and high running speeds compared to control conditions or ethylene-vinyl acetate (EVA) orthoses, thereby lowering the risk of overuse injuries such as stress fractures.^[200] Prophylactic knee braces, designed for athletes in contact sports like soccer and basketball, help prevent anterior cruciate ligament (ACL) tears by modulating knee movements in the coronal and transverse planes, reducing ACL strain during dynamic activities.^[201] Pediatric orthotics emphasize growth-accommodating designs to support developing musculoskeletal systems. For adolescent idiopathic scoliosis, the Boston brace—a rigid thoracolumbar sacral orthosis—prevents curve progression in about 73% of cases with initial Cobb angles between 20° and 40°, often achieving curve stabilization or modest reduction of around 13° on average after treatment.^[202]^[203] In treating congenital clubfoot, the Ponseti method employs serial long-leg casts followed by abduction orthotic bracing to gradually correct foot deformities, yielding success rates greater than 90% in maintaining correction when adhered to through early childhood.^[204] Adaptations for pediatric users prioritize lightweight materials to enhance mobility and compliance, such as carbon fiber ankle-foot orthoses (AFOs) that provide slimline support while allowing natural gait progression in active children.^[205] In athletes, these devices can improve running economy by reducing oxygen consumption at moderate intensities, potentially enhancing endurance performance metrics like sustained speed.^[206] Recent evidence underscores orthotics' role in injury prevention; for instance, prophylactic knee bracing has reduced medial collateral ligament (MCL) injuries by up to 50% in collegiate athletes compared to non-braced controls.^[207] In youth sports, custom orthotics contribute to lower extremity injury reductions of 20-30% by optimizing biomechanics during repetitive motions.^[208] Accessibility remains a challenge, particularly in developing regions where high costs limit orthotic provision; in sub-Saharan Africa, device expenses often exceed annual household incomes, restricting utilization among eligible patients, particularly children, despite proven efficacy.^[209]

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Orthotic Evaluation and Fitting - The National Sports Medicine Institute
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Lower Limb Orthotics Outcome Measures Toolkit Summary
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This part sets forth the classification of orthopedic devices intended for human use that are in commercial distribution.
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Upper Limb Orthotic Devices - Musculoskeletal Key
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Prophylactic knee braces have been reported to decrease peak tension magnitudes and impulse responses on knee ligaments.
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[PDF] An Orthotic Odyssey
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Introduction to Orthotics - Physiopedia
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ISO 8549-1:2020(en), Prosthetics and orthotics — Vocabulary
definitions of foot orthotics, head orthosis and soft orthosis have been added to the list of areas of orthotic practise (see 3.1); · a definition of the head ...
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[PDF] Use and abandonment rates of assistive devices/orthoses in ...
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Prosthetics and Orthotics Market Size to Hit USD 13.94 Bn by 2034
The global prosthetics and orthotics market size is estimated at USD 9.21 billion in 2025 and is anticipated to reach around USD 13.94 billion by 2034, ...
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Introduction to Spinal Orthotics - Physiopedia
A spinal orthosis is an external aid that is used to correct and support the spine. The spine is a complex anatomical structure and is key to our function.
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Helmet Therapy for Your Baby | Johns Hopkins Medicine
Helmet molding therapy, or cranial orthosis, is a type of treatment in which a baby is fitted with a special helmet to correct the shape of the skull. · Helmet ...
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Milwaukee brace - Physiopedia
The Milwaukee brace is used for conservative treatment of postural disorders. Its aim is to keep the body upright and prevent progression of the curve.Missing: hybrid | Show results with:hybrid
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Custom Spinal Orthoses - Orthomerica Products, Inc.
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Orthotics can be classified into the following types: static, static-progressive, or dynamic. In the early acute stages of burn rehabilitation, orthotics are ...
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[PDF] Spinal Orthoses: Principles, Designs, Indications, and Limitations
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Biomechanics for Cerebral Palsy Orthotics - Physiopedia
Orthotists use 3 point pressure in most orthotic designs to control angular movement. The three-point force system permits angular change or control over a ...
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The Biomechanics of Spinal Orthoses for Adolescent Idiopathic ...
Dec 8, 2024 · Notably, the fundamental mechanical principle for the orthotic treatment of AIS is mainly about the application of the controlling force. The ...
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Comparing the Advantages Of All Custom Orthotic Casting Methods
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A Review on 3D Scanners Studies for Producing Customized Orthoses
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Finite Element Analysis and a Pilot Study | ACS Omega
Jan 24, 2021 · Foot molds were created from both plaster casting and 3D scanning/printing methods. Custom foot orthoses were then fabricated from each mold.
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[PDF] Use of International Standard ISO 10993-1, "Biological evaluation of ...
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Biocompatibility assessment of biomaterials used in orthopedic ...
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ISO 22675:2016(en), Prosthetics — Testing of ankle-foot devices ...
This International Standard primarily specifies a cyclic test procedure for ankle-foot devices and foot units of external lower limb prostheses, distinguished ...
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Sep 8, 2023 · With 3D printing, designers and clinicians can rapidly iterate through various designs and make real-time adjustments based on patient feedback.
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Orthotic Shell Materials | Forward Motion
Aug 28, 2023 · Common orthotic shell materials include thermoplastics like Polypropylene, Nylon, and HMW plastics, and elastomers like EVA, Poron, and Cork.
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Jun 8, 2023 · In the realm of orthotics, Copolymer and Polypropylene are two of the most common thermoplastics employed. Polypropylene (Polypro) is renowned ...
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[PDF] Plastics for Orthotics & Prosthetics
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Three-dimensional Printing in Orthopaedic Surgery: Current...
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Prosthetics & Orthotics Market Size & Share 2025-2032
Carbon fiber remains the cornerstone of high-performance sockets and braces owing to its exceptional strength and stiffness, yet foam-based liners and silicone- ...
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Orthoses for Management of Neuromuscular Impairment - Physiopedia
The literature supports the use of AFO in neuromuscular impairments by demonstrating improved gait, functional mobility, and energy efficiency.
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Apr 27, 2025 · 0: No muscle activation. 1: Trace muscle activation, such as a twitch, without achieving full range of motion.Missing: orthotics | Show results with:orthotics
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Mechanism and Design Analysis of Articulated Ankle Foot Orthoses ...
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a multicenter study of their use by spinal cord injured patients
Objective: Use of reciprocating orthosis (RGO, ARGO, HGO) by 74 patients with complete traumatic spinal cord injury was studied. Lesion levels ranged from ...
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Functional walking ability of paraplegic patients - PubMed
FES and hybrid orthoses offer considerable potential for restoring standing and walking abilities in persons with SCI. However, improvements in their ...
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An automatic hinge system for leg orthoses - ResearchGate
Aug 7, 2025 · This paper describes a new automatic hinge system for leg orthoses, which provides knee stability in stance, and allows knee-flexion during ...
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Nov 15, 2023 · The study hypothesized that the CFC strut acts as an energy storage component during the terminal stance phase and then releases stored energy ...
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(PDF) Effect of AFO Design on Walking after Stroke: Impact of Ankle ...
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Mar 25, 2020 · Pilot test results showed an improved walking speed (25%), increased cadence (7.96 step/min), increased step length (7 cm), and a good foot ...
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Specialised orthotic care to improve functioning in adults with ...
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This review suggests that knee sleeves can effect functional improvements to knee problems. However, further work is needed to confirm this hypothesis.
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Jun 10, 2022 · Wearing knee sleeves may improve the individual's knee-related confidence [19,20,21]. Results of laboratory studies suggest that using such ...<|separator|>
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Preventing and treating lower extremity stress reactions ... - PubMed
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The use of orthoses in the treatment of carpal tunnel syndrome ... - NIH
Immobilization of the wrist in the splint (orthosis) is the most effective, initial method of conservative treatment of carpal tunnel syndrome (CTS).
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Splints and Orthosis for treating rheumatoid arthritis - PMC - NIH
Splints/orthoses for the treatment of rheumatoid arthritis include rigid or flexible wrist orthoses, static or dynamic finger orthoses, and specialized shoes ...
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Static progressive splinting - Journal of Hand Therapy
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The brace used to treat a compression fracture of the spine is designed to keep you from bending forward. It holds the spine in hyperextension (meaning more ...
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Nov 12, 2018 · Conclusion: The addition of the denneroll cervical orthotic to a multimodal program positively affected CMCPS outcomes at long term follow up.
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Oct 13, 2022 · This study investigates thoracic hyper kyphosis (THK) rehabilitation using the Denneroll™ thoracic traction orthosis (DTTO).
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Braces | University of Maryland Medical Center
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Aug 25, 2022 · The sacroiliac belt demonstrated significantly higher user satisfaction and similar effectiveness compared to the lumbar orthosis.
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Baby Helmet Therapy: Parent FAQs - HealthyChildren.org
Aug 31, 2020 · Helmet therapy (also called helmet orthosis) is a treatment that's prescribed to help mold the baby's skull into shape.
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For optimal effectiveness, it is recommended that helmet or band therapy begin by five months of age. The length of therapy depends on the individual case, but ...
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Cranial Remodeling - Medical Clinical Policy Bulletins - Aetna
The headband or helmet is custom made and custom fitted to the infant's head and is designed to actively guide the growth of the skull to a more normal shape.
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Baby Helmet Therapy — How does it Work? - Cranial Technologies
Infant helmet therapy, or cranial remolding orthosis, is a type of remolding therapy that treats plagiocephaly (flat head syndrome) in infants.
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A cranial remolding orthosis is a baby helmet that corrects deformational plagiocephaly (also known as flat head syndrome).
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Deformational plagiocephaly: Sorting out the diagnosis, optimal ...
Feb 1, 2023 · Skull growth rate decreases after 12 months of age, and helmet therapy becomes less effective. The typical duration of treatment is two to ...
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Impact of severity and therapy onset on helmet therapy in positional ...
Mean initial CVAI was 9.8%, which reduced to 5.4% after helmet treatment. Group 1 (<24 weeks) showed the highest absolute and relative rate of correction.
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Complications associated with molding helmet therapy for positional ...
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Complications associated with molding helmet therapy for positional ...
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Evidence-Based Care of the Child With Deformational ...
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3-D Printed Patient-Specific Cranial Helmet Market Research Report ...
... weight reduction, and aesthetic customization. Semi-rigid and soft helmets are gaining traction as well, particularly for mild cases or for use in infants ...
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Pediatric Cranial Remolding Helmet 2025 to Grow at XX CAGR with ...
May 17, 2025 · Recent innovations focus on improving ventilation, reducing weight, and incorporating features for easier cleaning and hygiene.
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CPSC Bicycle Helmet Standard
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Apr 11, 2024 · OSHA regulates head protection for general industry, construction, and maritime and requires employers to ensure affected workers wear ...
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Lightweight, hard-foam helmets provide good protection. They may come in a wide variety of styles that can be customized for individuals with seizures. Custom- ...
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May 15, 2024 · By distributing the force, EPS foam helps to minimize the impact on the wearer's head, reducing the risk of injury. This mechanism makes EPS ...What Is EPS Helmet? · Advantages of EPS Helmets · How to Mould EPS Helmet
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In a case-control study from Norway, helmet use reduced the risk of any head injury by 60% (adjusted OR: 0.40 (CI: 0.30 – 0.55)), of head contusions and ...
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Current helmets often cause heat buildup, discomfort, and fatigue, particularly in hot climates, leading to non-compliance in their use. Overheating arises ...
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Social Disparities in Helmet Usage in Bicycle Accidents Involving ...
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Ultimate Guide to Orthotic 3D Printing 2025: Complete Healthcare ...
Production Time: Traditional methods require 2-3 weeks vs 24 hours with 3D printing; Cost Reduction: 3D printing reduces production costs by 60-70%; Accuracy ...
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Smart AFO - App Store
The App allows orthotists to wirelessly stream sagittal ankle angle and sagittal moment gait data from sensors in the Smart AFO device in real-time via ...
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Deep Learning and IoT-Based Ankle–Foot Orthosis for Enhanced ...
Nov 14, 2024 · In creating an IoT-based Smart AFO, a range of IoT technology components are integrated to observe the gait patterns of AFO wearers in real time ...
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Smart AFO - YouTube
Jan 13, 2022 · The Smart Ankle-Foot Orthosis (Smart AFO) mobile application (App) requires pairing with the Becker Orthopedic Smart AFO device.
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First Robotic Exoskeletons For Paraplegia Win FDA Approval
The US Food and Drug Administration on Tuesday approved the first robotic exoskeleton to help people with lower body paralysis.
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Nov 28, 2023 · The ReWalk Exoskeleton can detect and react to changes in terrain, leading to a potentially new generation of smart exoskeletons.
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Advanced AI algorithms analyze patient-specific data such as body scans, movement patterns, and medical history to design customized assistive devices, orthoses ...<|separator|>
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footprint.AI is an AI-powered custom orthotics platform that creates personalized shoe inserts in just 3 minutes without clinic visits. Using smartphone-based ...
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Prosthetics and Orthotics Market Size & Outlook 2025 to 2035
Jun 30, 2025 · Orthotics will dominate with a 58.9% market share, while Prosthetic Clinics will lead the end-user segment with a 42.3% share. June 30, 2025 250 ...
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Composite Orthoses Market Analysis & Forecast 2035
Aug 24, 2025 · The Global Composite Orthoses Market is expected to grow at a CAGR of 4.5% from 2025 to 2035, driven by increasing prevalence of musculoskeletal ...
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The Effect of EVA and TPU Custom Foot Orthoses on Running ...
Sep 18, 2019 · TPU reduced both mean and peak vertical loading rate by ~12% at both speeds compared to CON and EVA. A lower vertical loading rate and vertical ...
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Biomechanical Effects of Prophylactic Knee Bracing on Anterior ...
Jan 1, 2023 · Conclusions: Prophylactic knee braces may serve to reduce ACL injury risk by modulating knee coronal and transverse plane movements and ACL load ...
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Effectiveness of the Boston Brace in the Treatment of Paediatric ...
May 20, 2023 · Brace treatment prevented the need for scoliosis correction in 73.2% of adolescents with IS of 20–40°. These results are comparable to those ...<|separator|>
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Curve progression after long-term brace treatment in adolescent ...
Oct 30, 2017 · In all 93 patients, the mean scoliotic curve was reduced of 13.41° (±8.1) at the end of weaning. The mean pre brace Cobb angle of 32.17° (±9.12) ...
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Mar 29, 2023 · The Ponseti method is a systematic series of casting and orthotic bracing treatments that permanently and nonsurgically corrects clubfoot in young children.
[196]
Best AFOs for Kids Sport [2025 Guide] - Melbourne - Orthotics Plus
Apr 23, 2025 · Lightweight and slimline design, making them ideal for fitting into sports shoes. · Offers propulsion assistance, acting as a spring to aid ...Types Of Afos Suitable For... · Customisation For... · How Often Should An Afo Be...
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Effects of Foot Orthotics on Running Economy - Foot Levelers
May 29, 2020 · Results: Decreases in VO2 at several moderate exercise intensities (F(1,5)footwear = 10.37, P = .023) and increases in vVO2max (t5 = 4.20, P ...Missing: max athletes
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Does the use of prophylactic knee braces prevent knee injuries in ...
The RCT of 1,396 athletes showed that prophylactic knee braces significantly reduced MCL injuries, with 25 injuries in nonbraced athletes and 12 injuries in ...
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The Value of Custom Orthotics for Young Athletes
Apr 9, 2025 · Studies have shown that custom orthotics play a significant role in preventing injuries and improving performance in young athletes. According ...
[200]
Determinants of utilization of prostheses and orthoses following ...
Cost is a significant barrier to the utilization of prostheses and orthoses in sub-Saharan Africa. The cost of prosthetic and orthotic devices can be ...<|control11|><|separator|>