Search Results (22)

The rapid development of additive manufacturing has enabled the production of personalized biomedical devices, including custom orthoses that must retain their structural integrity under demanding physiological conditions. This study evaluates the performance of 3D-printed polymers—blue and white polylactic acid (PLA), Standard Blue Resin, and an ecological soy-based resin—after exposure to simplified, controlled saline environments related to sweat contact and hygiene-associated conditions. Moisture absorption and Shore A hardness were analyzed as response variables to assess material stability under different experimental conditions. A surface methodology based on a Box–Behnken design was used to quantify the effects of specimen thickness (x₁), NaCl concentration (x₂), and immersion time (x₃) on the selected dependent variables. The results indicate that Standard Blue Resin showed the greatest surface hardness stability, whereas the bio-based materials (PLA and ecological resin) were more susceptible to moisture absorption, particularly in thinner polymeric sheets. The fitted quadratic models provide a predictive framework for optimizing material selection and geometric design in biomimetic wearable devices, supporting the development of orthoses with improved durability, hygiene, and long-term functional performance. Full article

Wearable pressure-sensing orthoses are increasingly used in neurorehabilitation to support gait recovery, monitor plantar pressure distribution, and improve patient mobility during repetitive therapy sessions. The performance of these devices depends strongly on the materials used in the skin-contact layer, since material properties influence comfort, flexibility, durability, and force transmission during daily use. This study proposes a hybrid multi-criteria decision-making framework based on the Analytic Hierarchy Process (AHP) and the VIKOR method for material selection in sensor-integrated plantar orthoses. Five candidate materials, ethylene vinyl acetate (EVA), polyethylene (PE), polyurethane (PU), cobalt–chromium–molybdenum alloy (CoCrMo), and polypropylene (PP), were evaluated using five criteria: comfort and skin compatibility, elasticity, fatigue resistance, density, and energy dissipation. AHP was applied to determine the relative importance of the evaluation criteria using expert judgment, while VIKOR was used to rank the material alternatives and identify the compromise solution. The results showed that polyurethane achieved the best overall performance due to its balanced behavior in comfort, elasticity, and fatigue resistance, which are essential properties for long-term wearable neurorehabilitation devices. A sensitivity analysis confirmed that moderate variations in expert weighting did not modify the final ranking. Compared with conventional selection approaches based mainly on isolated material properties, the proposed framework offers a clear and reproducible method for integrating mechanical and user-related requirements into the material selection process for wearable orthoses. Full article

Background: Wearable powered gait orthoses offer a clinically flexible alternative to treadmill-based robotic systems, yet evidence on different device configurations matched to the site of neuromuscular impairment remains limited. Methods: In this multicenter prospective pilot study, 75 participants with neurological gait impairment were allocated to a hip orthosis (HO; n = 39) or a knee–ankle–foot orthosis (KAFO; n = 36) group based on clinical assessment of predominant gait pattern. Both groups completed six overground gait-training sessions over three weeks. Primary outcomes were the Six-Minute Walk Test (6MWT) and Ten-Meter Walk Test (10MWT), assessed without (WO) and with (WITH) the device. Secondary outcomes were the Berg Balance Scale (BBS), Timed Up and Go Test (TUG), and Dynamic Gait Index (DGI), all assessed without the device. Wilcoxon signed-rank tests were used for pre-to-post comparisons. Results: Both groups demonstrated significant improvements in primary walking outcomes, with consistent gains in unassisted (WO) 6MWT and 10MWT performance across groups and in device-assisted (WITH) 10MWT speed; the one exception was a small statistically significant but clinically negligible decrease in device-assisted 6MWT in the KAFO group (−4.1 m, below established MCID). In the KAFO group, BBS improved by a median of 5.5 points (43.5 to 49.0, p = 0.0005), TUG decreased by 5.1 s (p < 0.001), and DGI improved by 6.0 points (p = 0.002); all three changes exceeded published minimum detectable change thresholds. In the HO group, pre-to-post differences in BBS (+1.0), TUG (+0.8 s; an unfavorable direction), and DGI (−2.0; an unfavorable direction) were statistically detectable but small in absolute magnitude, fell at or below published thresholds for minimum detectable change, and should not be interpreted as clinically meaningful improvement. The WO-WITH performance gap in the KAFO group narrowed substantially after training, with 10MWT time no longer differing significantly between conditions at post-training (p = 0.116). Conclusions: Six sessions of gait pattern-matched powered gait orthosis training produced clinically meaningful within-group improvements in walking outcomes in both groups. In the KAFO group, balance and functional mobility outcomes also showed clinically meaningful improvements; in the HO group, balance and functional mobility outcomes showed only statistically detectable but clinically non-meaningful fluctuations around near-ceiling baseline scores. Walking benefits generalized to unassisted ambulation in both groups. These findings support the feasibility of an individualized orthosis prescription framework and provide a basis for future randomized controlled trials. Full article

Ankle–foot orthoses (AFOs) are widely used in the rehabilitation of patients with neurological or musculoskeletal disorders. However, treatment outcomes may be influenced by incorrect use of the device or by inappropriate orthosis selection. Since many types of AFOs are available, differing in materials, stiffness, and geometry, an objective evaluation tool can support clinical decision-making. This work presents the design, development, and characterization of an instrumented AFO able to quantify relevant gait parameters in an objective way. The proposed device integrates three measurement modalities in a compact wearable structure. Two longitudinal strain gauges estimate ankle plantar- and dorsiflexion angles. Two force-sensitive elements detect foot–ground contact and allow identification of stance and swing phases of the gait cycle. A single inertial measurement unit (IMU) is used to measure lateral shank inclination. The strain-gauge-based angle estimation was validated against a gold-standard motion capture system, achieving a root mean square error of approximately 1.6 degrees and showing higher accuracy than the IMU for plantar/dorsiflexion measurement, while maintaining a simple electronic architecture. The force sensors were validated using a force platform and demonstrated reliable detection of loading and unloading events. Monitoring lateral inclination through the single IMU provides additional information related to balance and potential fall risk. Data are transmitted via Bluetooth Low Energy (BLE) to a custom Python-based application for real-time visualization and recording. Overall, the results validate the electronic instrumentation and demonstrate reliable system performance, indicating that the proposed instrumented AFO represents a promising platform for objective gait assessment and future clinical applications. Full article

Compliant mechanisms have contributed to many advances in soft robotics, and there is strong motivation to translate these ideas to assistive devices where adaptive motion at the human interface is required. This work presents novel reconfigurable compliant joints (RCJs) as a parameterized joint element for functional biomimicry in lower-extremity joints for prosthetic knees and ankle–foot orthoses, with concepts that extend to other limb joints. The RCJ uses a rigid hub and outer ring joined by an array of flexible links with centerlines defined by cubic Bézier curves. Link shapes are organized into four Bézier classes (A–D), with base types using 10, 12, or 14 uniformly distributed link slots and variants generated by modifying active-link count and distribution, forming a structured morphology space of 12 configurations for machine design. Dual-extrusion 3D-printed prototypes are characterized by a custom testing apparatus using a 2.2 kN load cell at 25 mm/s over a 0–90° rotation range across six recorded load cycles to measure torque–angle curves and stiffness under large deformations. Angle-dependent stiffness is evaluated over three fixed intervals (0–30°, 30–60°, and 60–90°) to quantify multi-stage behavior. A 2-dimensional corotational frame model and a Simscape Multibody model, including a rolling-contact knee configuration, use the same parameterization to relate geometry, nonlinear mechanics, and system-level motion. Experiments and simulations show multi-stage torque–angle profiles and predictable stiffness modulation across all configurations, with both magnitude and transition angle tunable through Bézier class and active-link distribution, positioning the RCJ as a CAD/CAE-compatible joint architecture for assistive devices or wearable robotic systems and a basis for advancing functional biomimicry in compliant mechanism design. Full article

Ensuring user safety while enabling independent mobility is crucial to autonomous healthcare and rehabilitation robots, such as active lower-limb orthoses and exoskeletons. A key requirement for these devices is to provide full assistance without supervision; however, existing designs do not simultaneously satisfy autonomous operation and inherent safety. To address this gap, a novel safety principle, Safety by Design, and a corresponding system architecture for a fully assistive active knee orthosis are introduced. The proposed architecture is based on a comprehensive risk analysis for the use of active orthoses and exoskeletons and integrates redundancies for all safety-critical components while minimizing additional weight. This redundancy enables the orthosis to remain operational at reduced power in the event of component failure, improving both user safety and system reliability. The design supports safe, unsupervised operation by ambulatory users, enhancing independent patient mobility and the performance of the gait activities of level walking, stair climbing and sitting down/standing up. The proposed architecture is scalable and adaptable to a wide range of robotic devices. By improving robustness, efficiency, and safety, this work contributes to the advancement of autonomous biomedical robotic systems and wearable assistive devices. Full article

Functional ankle instability (FAI) is a common consequence of lateral ankle sprains, characterized by impaired sensorimotor control. While orthoses and localized vibration have shown individual benefits for FAI, their combined application in a wearable device has not been previously investigated. This pilot randomized trial compared the effects of a vibrotactile foot orthosis (VFO) and a vibrotactile ankle orthosis (VAO) on joint position sense (JPS) and postural control in individuals with FAI. Sixteen participants were randomized to receive either a VFO or a VAO, both delivering 30–50 Hz pulsed vibration in 20 min sessions, three times a week, for two weeks. Outcome measures included joint position sense (JPS) error (°), center of pressure (COP) velocity (mm/s), the Star Excursion Balance Test (SEBT), and the Six-Meter Hop Test (SMHT), which were assessed pre-intervention, immediately post-intervention, and after two weeks of use. The analysis showed a statistically significant interaction between time and intervention group for JPS error (p = 0.02, η² = 0.42). Specifically, the VFO group improved JPS significantly more than VAO at two weeks follow-up (MD = −1.75°, p = 0.005, d = −1.68). Both groups significantly reduced in anteroposterior COP velocity after two weeks (VFO: MD = 1, p = 0.003, d = 1.47; VAO: MD = 1.39, p ˂ 0.001, d = 2.05) with no between-group differences. No changes were observed in the SEBT or SMHT. Plantar-based vibrotactile stimulation was more effective than ankle-based stimulation in enhancing proprioceptive acuity in individuals with FAI. Both interventions improved static postural stability, supporting the potential of integrated vibrotactile orthoses in FAI rehabilitation. No major practical issues were reported during the intervention. Two participants experienced minor discomfort related to the electronic housing bulk in the first week, which was resolved by week two. No further complaints regarding device weight or usability were observed. Full article

Football (soccer) is the world’s most widely played sport, but it carries a high incidence of traumatic injuries, particularly to the head, face, and lower limbs. Once regarded as a low-equipment discipline, the role of protective devices has expanded substantially in recent decades, both in injury prevention and in return-to-play strategies. This review provides a comprehensive overview of the historical evolution, typology, and materials of football protective equipment, with additional focus on regulatory frameworks, cultural acceptance, and illustrative cases from elite athletes. Shin guards remain the only mandatory device, yet the use of facial masks, headgear, braces, and orthoses is increasing, particularly following high-profile injuries. Advances in carbon fiber composites, thermoplastics, viscoelastic foams, and additive manufacturing have enabled lightweight, customized devices that balance protection with comfort and adherence. Beyond biomechanics, psychological reassurance, esthetics, durability, and hygiene strongly influence player compliance and perception. Despite this progress, critical challenges remain. Football lacks standardized testing protocols, clear certification pathways, and longitudinal studies on long-term outcomes. Evidence is particularly limited for youth athletes and newer categories of equipment. Looking ahead, the integration of wearable technologies, systematic hygiene and durability testing, and sustainable materials could transform protective gear into multifunctional tools for safety, monitoring, and performance optimization. Protective equipment in football has thus evolved into a multidisciplinary field at the intersection of medicine, engineering, psychology, and regulation. Future advances will depend on stronger collaboration between clinicians, researchers, governing bodies, and manufacturers to ensure safe, effective, and widely accepted protective solutions at all levels of the game. Full article

Acute ankle sprains frequently lead to chronic ankle instability and muscle atrophy by causing immobilization, which necessitates real-time stiffness modulation for ankle–foot orthoses (AFOs). This paper proposes Active Variable Compression Shoes (AVC-Shoes), an ankle support system inspired by the “heel-lock taping” technique, which employs a wire–fabric compression mechanism to selectively stiffen ankle joints at crucial points in the gait cycle. The experimental results confirmed that AVC-Shoes achieve variable ankle stiffness in all directions, demonstrating dorsiflexion and plantarflexion stiffness ranges of up to 8.3 and 5.9 Nm/rad, respectively. Additionally, preliminary human testing involving three healthy participants revealed that the gastrocnemius muscle activity during the push-off phase in the active compression mode was significantly higher (by 19%) than that in the brace mode. By selectively increasing stiffness at heel strikes, AVC-Shoes represent a promising advancement toward next-generation AFOs capable of stabilizing the ankle while preventing muscle atrophy, which is associated with prolonged brace use. Full article

The lack of social acceptability for wearable devices such as orthopedic foot orthoses can lead to irregular usage and missed health benefits, as shown in prior studies. While AI-generated designs have been explored for prototyping aesthetic hand orthoses, their impact on social acceptability, particularly for foot orthoses, remains unknown. The current state of research is limited, as no empirical evidence exists on whether AI-designed orthoses influence acceptance, nor has the role of customized generative pre-trained transformers (GPTs) and specific prompting strategies been examined in this context. To address these gaps, we conducted two mixed-methods studies to investigate (1) the impact of AI-generated orthosis designs on social acceptability compared to existing orthopedic products and development concepts and (2) how a customized GPT and different prompt keywords influence acceptance. Our results show that AI-generated designs significantly enhance social acceptance across orthotic categories. Furthermore, we found that personalized GPTs and targeted prompt keywords significantly influence user perception. Overall, our findings highlight the potential of using AI to create socially acceptable design solutions for wearable technology and offer new applications for future smart devices. We contribute to generative AI in product design and provide concrete recommendations for optimizing prompting strategies to enhance social acceptance. Full article

Foot pain represents one of the most common symptoms in lower limb issues, especially in elderly individuals. This condition, often associated with other pathologies, increases the risk of falling. To better understand the risk of falls, it is essential to assess patients’ postural stability. In this pilot study, we aimed to set a protocol to prevent the falling risk. We propose the use of inertial sensors (IMUs) to detect even minimal body oscillations in a non-invasive, rapid, and cost-effective way. We have analyzed a sample of 35 patients (age = 58 ± 14 years, female = 20/male = 15) to investigate the total range of body sway in the anteroposterior (AP) and mediolateral (ML) directions during static balance in relation to their age and BMI. The analysis of the collected parameters (sway area, sway pathAP, and sway pathML) has showed a lower stability at t1, at the time of orthosis application, with respect to the previous condition, implied by the necessary period of adaptation to the new plantar device. In fact, the postural parameters have visibly improved at 30 days (t2). Comparing the results obtained in the different postural exercises, we have obtained significant differences between the natural standing position with eyes open and the others. According to these results, we can suppose that using inertial sensors associated to postural exercise is the best way to assess a patient’s postural stability and that the progressive improvements may be more marked over a longer period, such as six months (t3). Full article

Ankle-foot orthoses (AFOs) have been commonly prescribed for stroke survivors with foot drop, but their impact on the contractions of paretic tibialis anterior (TA) and medial gastrocnemius (MG) has remained inconclusive. This study thus investigated the effect of AFOs on these muscle contractions in stroke survivors. The contractions of paretic TA and MG muscles were assessed in twenty stroke patients and compared between walking with and without AFOs, using a novel wearable dynamic ultrasound imaging and sensing system. The study found an increase in TA muscle thickness throughout a gait cycle (p > 0.05) and a significant increase in TA muscle surface mechanomyography (sMMG) signals during the pre- and initial swing phases (p < 0.05) when using an AFO. MG muscle thickness generally decreased with the AFO (p > 0.05), aligning more closely with trends seen in healthy adults. The MG surface electromyography (sEMG) signal significantly decreased during the initial and mid-swing phases when wearing an AFO (p < 0.05). The TA-MG co-contraction index significantly decreased during initial and mid-swing phases with the AFO (p < 0.05). These results suggest that AFOs positively influenced the contraction patterns of paretic ankle muscles during walking in stroke patients, but further research is needed to understand their long-term effects. Full article

The behavior of pedestrians in a non-constrained environment is difficult to predict. In wearable robotics, this poses a challenge, since devices like lower-limb exoskeletons and active orthoses need to support different walking activities, including level walking and climbing stairs. While a fixed movement trajectory can be easily supported, switches between these activities are difficult to predict. Moreover, the demand for these devices is expected to rise in the years ahead. In this work, we propose a cloud software system for use in wearable robotics, based on geographical mapping techniques and Human Activity Recognition (HAR). The system aims to give context to the surrounding pedestrians by providing hindsight information. The system was partially implemented and tested. The results indicate a viable concept with great extensibility prospects. Full article

Introduction: The choice of materials for covering plantar orthoses or wearable insoles is often based on their hardness, breathability, and moisture absorption capacity, although more due to professional preference than clear scientific criteria. An analysis of the thermal response to the use of these materials would provide information about their behavior; hence, the objective of this study was to assess the temperature of three lining materials with different characteristics. Materials and Methods: The temperature of three materials for covering plantar orthoses was analyzed in a sample of 36 subjects (15 men and 21 women, aged 24.6 ± 8.2 years, mass 67.1 ± 13.6 kg, and height 1.7 ± 0.09 m). Temperature was measured before and after 3 h of use in clinical activities, using a polyethylene foam copolymer (PE), ethylene vinyl acetate (EVA), and PE-EVA copolymer foam insole with the use of a FLIR E60BX thermal camera. Results: In the PE copolymer (material 1), temperature increases between 1.07 and 1.85 °C were found after activity, with these differences being statistically significant in all regions of interest (p < 0.001), except for the first toe (0.36 °C, p = 0.170). In the EVA foam (material 2) and the expansive foam of the PE-EVA copolymer (material 3), the temperatures were also significantly higher in all analyzed areas (p < 0.001), ranging between 1.49 and 2.73 °C for EVA and 0.58 and 2.16 °C for PE-EVA. The PE copolymer experienced lower overall overheating, and the area of the fifth metatarsal head underwent the greatest temperature increase, regardless of the material analyzed. Conclusions: PE foam lining materials, with lower density or an open-cell structure, would be preferred for controlling temperature rise in the lining/footbed interface and providing better thermal comfort for users. The area of the first toe was found to be the least overheated, while the fifth metatarsal head increased the most in temperature. This should be considered in the design of new wearables to avoid excessive temperatures due to the lining materials. Full article

The number of people with diabetes is rising day-by-day, which also raises the incidence of diabetic ulcers, sensation loss in the foot’s plantar area, and in extreme instances, amputations. Using customized shoes, unloading orthoses, insoles, and other strategies may help control these issues to some degree. In this work, a novel modular diabetic insole was designed and fabricated to effectively offload the abnormal or peak plantar pressures in diabetic patients. The pressure values in the plantar region were quantified using an in-house-developed plantar pressure-measuring insole consisting of force sensitive resistor (FSR) sensors. The effectiveness of the modular diabetic insole was tested qualitatively and quantitatively. The qualitative performance of the insole was reported using Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0) in terms of subjective parameters like comfort, ease of use, effectiveness, etc. and calculated as 4.7 ± 0.18. Thereafter, the wearable pressure-measuring insole was used to investigate the feasibility of modular insole for the plantar pressure offloading during standing and walking conditions. It was observed that the maximum average zonal pressure (AZP) was reduced by up to 99% from 121.30 ± 3.72 kPa to 0.22 ± 0.18 kPa for the standing condition whereas it was reduced to 6.76 ± 2.03 kPa from 197.71 ± 3.21 kPa with a percentage value of 96% for the walking condition. In conclusion, the findings of this work validate the effectiveness of the modular diabetic insole as an intervention tool for diabetic foot ulcer prevention. Full article