Orthotic Brace Research Articles

Investigative and Usability findings of the Move-D Orthotic Brace Prototype for Upper Extremity Tremors in Pediatric Patients: An unblinded, experimental study

Investigative and Usability findings of the Move-D Orthotic Brace Prototype for Upper Extremity Tremors in Pediatric Patients: An unblinded, experimental study

Non-surgical approaches to the management of chest wall deformities

Chest wall deformities in children encompass a broad spectrum of disorders but pectus excavatum and carinatum are by far the most common. Treatment varies substantially by center, and depends on patient symptoms, severity of disease, and surgeon preference.Historically, surgical approaches were the mainstay of treatment for these disease processes but new advances in non-surgical approaches have demonstrated reasonable results in select patients. These non-surgical approaches include vacuum bell therapy, autologous fat grafting and hyaluronic acid injections for pectus excavatum, and orthotic brace therapy for pectus carinatum. There is debate with regards to optimal patient selection for these non-surgical approaches, as well as other barriers including reimbursement issues.This paper will review the current non-surgical approaches to chest wall deformities available, including optimal patient selection, treatment protocols, indications, contraindications, and outcomes.

Investigative and Usability Findings of the Move-D Orthotic Brace Prototype for Upper Extremity Tremors in Pediatric Patients: An Unblinded, Experimental Study

Tremors affect pediatric and adult populations, with roughly 3% of people worldwide experiencing essential tremors. Treatments include medication, deep brain stimulation, occupational/physical therapy, or adaptive equipment. This unblinded experimental pre-test–post-test study was performed (April–September 2021) at Children’s Health of Orange County, evaluating the effectiveness of Move-D, a novel orthotic brace, on pediatric tremors. Ten participants (14–19 years old) experiencing upper extremity tremors (5 essential, 2 dystonic, 1 coarse, 1 postural, and 1 unspecified) were enrolled. Participants completed a usability survey and performance was measured utilizing the Bruininks–Oseretsky Test of Motor Proficiency, second edition, with and without the brace, using one-sided t-tests of mean differences. Move-D improved age-equivalent scores for fine motor precision by 20.5 months and upper limb coordination by 15.1 months. Manual coordination percentile rankings increased by 2.9%. Manual dexterity performance was unaffected. The usability survey revealed that 7/10 participants agreed or strongly agreed that they could move their arm freely while wearing the brace, the brace reduced their tremors, and they felt comfortable wearing the brace at home. Through standardized testing and findings from the usability survey, Move-D showed an improvement of functional abilities in a pediatric population with tremors.

The Type of Conservative Management Could Be Related to the Strength of the Inspiratory Muscles of Adolescents with Idiopathic Scoliosis—A Case Series

Adolescent idiopathic scoliosis (AIS) is a lateral curvature of the spine with a Cobb angle of at least 10° with an unknown etiology. It is recognized that AIS may affect respiratory function. This study aims to describe and compare respiratory function in a case series of patients with scoliosis who underwent different types of therapeutic management: no intervention, orthotic brace, and global postural reeducation (GPR). Fifteen AIS patients were included in this study (seven no intervention, four orthotic brace and four GPR). Lung function and inspiratory muscle strength were measured and analyzed, as well as sociodemographic, clinical, and anthropometric variables. Significant correlations were observed between height (cm) and maximum inspiratory pressure (MIP) reference (cmH2O) and forced vital capacity (FVC) (liters) (r = 0.650 and r = 0.673, respectively; p < 0.01); weight (Kg) and MIP reference (cmH2O) (r = 0.727; p < 0.01); and Main curve degrees (Cobb angle) and FVC% (r = −0.648; p < 0.01). The AIS cases that underwent GPR treatment presented a greater MIP (% predictive) compared to the no intervention and brace cases (201.1% versus 126.1% and 78.4%, respectively; p < 0.05). The results of this case series show a possible relation whereby patients undergoing treatment with the GPR method have greater inspiratory muscle strength compared to the no intervention and brace cases. Studies with larger samples and prospective designs must be performed to corroborate these results.

Comparison of Water Absorption and Drying in Distal Radius Fracture Casts and Orthoses

Introduction:Traditional plaster and fiberglass casts are not waterproof. This experimental study compares the water-resistant and drying properties of two commercially available orthoses with traditional cast liners.Methods:Two orthotic brace systems were selected for comparative waterproof testing with plaster and fiberglass traditional cast liners. This entailed water submersion for 10 seconds, followed by light drip drying for another 10 seconds. Moisture levels were then measured at four different locations immediately after drip drying and then every 15 minutes up to 45 minutes.Results:The Zero-Cast Wx orthosis retained the least moisture after initial immersion and was fully dry within 45 minutes. The Exos upper extremity brace also demonstrated a low initial mean moisture content but lost little moisture during drying. In comparison, both the cotton-lined plaster cast and Delta Dr. cast liner systems demonstrated the greatest amount of water absorbed and moisture retention.Discussion:Both orthotic brace systems demonstrated markedly less water absorption compared with the cotton-lined plaster cast and Delta Dr. cast liner systems. The Zero-Cast Wx was the only orthosis to fully dry in 45 minutes.Conclusion:Both orthotic brace systems provide superior water-resistant properties to traditional cotton-lined plaster cast or fiberglass Delta Dr. cast liner systems.

Novel device for nonsurgical correction of rigid forefoot adduction in children.

Forefoot adduction deformity (FAD) (commonly called metatarsus adductus) is reported as the most common congenital foot deformity in newborns. Early diagnosis and treatment are important in rigid cases, as better outcomes have been reported if treatment was initiated before 9 months of age. While casting and splinting is the current standard of care for nonsurgical management of rigid FAD (RFAD), several orthoses have demonstrated equal benefit. The Universal Neonatal Foot Orthotic (UNFO) brace is below ankle orthosis that provides continuous pressure, thereby correcting the deformity without casting. To the best of our knowledge, UNFO is the first brace that operates below the ankle. The aim of this study was to compare the effectiveness of UNFO shoe to standard serial casting in the treatment of RFAD in infants. Between the years 2012 and 2019 we treated 147 feet (94 patients): 52 using the UNFO shoes and 95 by standard casting and splinting protocol. The treatment groups were compared based on treatment duration, complications, and recurrence of deformity. Mean full-time treatment duration was significantly shorter in the UNFO group, while no significant difference in the total duration of treatment was observed. Similar complication and recurrence rates were demonstrated. In conclusion, treatment with UNFO is equally effective to serial casting. The use of UNFO increases convenience and diminishes social burden, thus providing a distinct advantage over other treatment modalities.

A Layer Jamming Actuator for Tunable Stiffness and Shape-Changing Devices.

Changing the shape and the stiffness of a device in a dynamic and controlled way enables important advancements in the field of robotics and wearable robotics. Variable stiffness materials and technologies can be used to address this challenge. In particular, layer jamming actuation is a very promising technology, featured by high efficiency and low cost. In this article, a stiffness- and shape-changing device based on a novel mechanism including a multiple-chamber structure is proposed. It allows to effectively modulate the shape and stiffness of a device, by activating two jamming chambers while pressurizing/depressurizing one or more interposed inflatable chambers. Prototypes with a size of 45 × 270 mm2 and an average thickness ranging from 4.4 to 13 mm were developed and their ability to undergo a stiffness change over two orders of magnitude was demonstrated. The prototypes were also able to change their shape according to the position and inflation level of the interposed inflatable chambers, thus resulting in an overall deflection >10 mm. The possibility to wear the system as an orthotic brace was also demonstrated: this technology increased the patient comfort in static positions, yet keeping a supportive function when needed (e.g., in dynamic conditions). The device working principle highlighted in this article could also be exploited in other domains, for example, to build walking soft robots, prostheses, or grippers, as demonstrated through additional tests.

Magnetic resonance imaging study of orthotic balloon brace used for the treatment of pectus carinatum

Aim: A compressive orthotic brace is considered the first line therapy for patients with pectus carinatum. We designed a brace made of a non-metallic binder equipped with a balloon which can be insufflated to apply variable compression pressure to chondrogladiolar pectus carinatum. The study aimed to study the effect of this brace on patients with pectus carinatum, dynamic magnetic resonance imaging (MRI) studies were obtained.

A true silent compartment syndrome in a competent sensate patient: Case report

A true silent compartment syndrome in a competent sensate patient: Case report

Design and characterization of a torque-controllable actuator for knee assistance during sit-to-stand.

Individuals with post-stroke hemiparesis often have difficulty standing out of a chair. One way to potentially improve sit-to-stand is to provide knee extension assistance using a powered knee exoskeleton. An exoskeleton providing unilateral, partial assistance during sit-to-stand would need to be torque-controllable. There are no knee exoskeletons on the market suitable for conducting experiments assisting stroke patients with sit-to-stand, so to enable such experiments a research device was developed. The purpose of this report is to present the design of a novel knee exoskeleton actuator that uses a fiberglass leaf spring in series to improve torque-controllability, and present a characterization of the actuator performance. The actuator is capable of the required torque and speed for sit-to-stand, has high bandwidth (25 Hz), low output impedance at low frequencies (<;0.5 Nm), and excellent torque tracking. An orthotic brace built upon this actuator will enable an in-depth study on the biomechanical effects of providing stroke subjects with knee extension assistance during sit-to-stand.

A method for early detection of the initiation of sit-to-stand posture transitions

A powered lower extremity orthotic brace can potentially be used to assist frail elderly during daily activities. This paper presents a method for an early detection of the initiation of sit-to-stand (SiSt) posture transition that can be used in the control of the powered orthosis. Unlike the methods used in prosthetic devices that rely on surface electromyography (EMG), the proposed method uses only sensors embedded into the orthosis brace attached to the limb. The method was developed and validated using data from a human study with 10 individuals. Each human trial included different sets of sitting, standing and walking activities originating from various initial postures. Features from the sensor signal were extracted and aggregated in lagged epochs to incorporate the time history. Principal component analysis (PCA) was used to reduce the feature set. The principal components were then used in a leave-one-out manner to train a linear support vector machine (SVM) classifier to perform early detection of the SiSt posture transition. The proposed method achieved the sensitivity of 100% and the specificity 92.94% of trials without false positives. The average detection time (DT) of 0.1341 ± 0.3310 s following the start of transition demonstrated early recognition of the initiation of SiSt transition.

Investigating ‘Exo-Skeleton’ Design and Fabrication Challenges for the Hand Region Using Material Extrusion Processes

Abstract: Orthotic brace design and manufacturing can be problematic for people who have physical dimensions in the 5 th or 95 th percentile regions, or for people with unique chronic conditions. Advanced manufacturing tools provide opportunities to realize specialty braces. The goal in this research paper is to investigate solutions for finger and hand brace design and fabrication. Parametric design approaches are taken, and select solutions are presented, which have been fabricated using material extrusion processes. Research in this area is ongoing as many practical issues have been raised throughout this project.

Treatment for spondylolysis and spondylolisthesis in children.

To review outcome of 44 children who underwent conservative or surgical treatment for spondylolysis or spondylolisthesis. Records of 25 male and 19 female children aged 5 to 14 (mean, 10.2) years who underwent conservative (n=39) or surgical (n=5) treatment for spondylolysis (n=19) or spondylolisthesis (n=25) were reviewed. Conservative treatment involved application of a thoracolumbosacral orthotic brace for all day except bedtime until symptoms resolved and then physiotherapy including exercises to strengthen the abdominal and back muscles and stretching exercises of the hamstrings and hip flexors. Surgery (instrumented posterolateral fusion [n=4] or Wiltse posterolateral fusion [n=1]) with allografts was indicated in patients with refractory pain (n=2) or nerve root irritation (n=1) and in patients with iatrogenic spondylolisthesis (n=2), followed by application of the brace for 3 months and then physiotherapy. Outcome was assessed using the Seitsalo scoring system. The mean follow-up period was 6.5 (range, 3-10) years. No patient developed any postoperative complication. Outcome was excellent in 35 patients, good in 8, and fair in one. All 5 patients who underwent posterolateral fusion for refractory spondylolisthesis achieved good outcome. In 11 patients with spondylolysis, the pars defect healed. None of the spondylolysis progressed to spondylolisthesis. All displacements remained stable, without any progression. Conservative treatment is effective for most patients with spondylolysis or spondylolisthesis. Instrumented posterolateral fusion is indicated in patients with persistent symptoms and for iatrogenic cases.

Early detection of sit-to-stand transitions in a lower limb orthosis.

This paper describes a method for early detection of posture transitions in a powered orthotic brace purposed for assisting elderly people in sit-to-stand transitions. The detection system is constructed using a linear Support Vector Machine classifier that is trained from features extracted from the signals produced by the sensors mounted on the orthosis. The sensors include accelerometers, potentiometers, gyroscopes and force sensors. The data were collected from 9 healthy individuals that performed various activities, including transitions between sitting, standing and walking. The collected sensor data were processed, normalized and manually annotated to label all posture transitions. A Support Vector Machine classifier was trained and validated in a leave-one-out manner to detect early onset of sit-to-stand transitions. Use of lagged windows was examined in efforts to increase accuracy. The proposed method was to detect posture transitions with a high detection rate and a relatively low number of false positives.

Surface topography scan as a source for orthotic brace design. Technique and case presentation

Accurate adjustment and individualized brace design may warrant the optimal brace manufacturing that fit the patient's body surface. Computerized methods may improve bracing treatment.

Evaluation of the treatment of pectus carinatum with compressive orthotic bracing using three dimensional body scans

PurposeThe purpose of this study is to measure the effectiveness of compressive orthotic brace therapy for the treatment of pectus carinatum using an adjusted Haller Index (HI) measurement calculated from 3D body scan (BS) images. MethodsPediatric patients with pectus carinatum were treated with either compressive orthotic bracing or observation. An adjusted BS Haller index (HI) was calculated from serial 3D BS images obtained on all patients. Medical records were evaluated to determine treatment with bracing and brace compliance more than 12hours daily. Compliant patient measurements were compared to non-compliant and non-brace groups. ResultsForty patients underwent compressive orthotic bracing, while ten were observed. Twenty-three patients were compliant with bracing, and seventeen patients were non-compliant. Compliant patients exhibited an 8.2% increase, non-compliant patients had a 1.5% increase, and non-brace patients exhibited a 2.5% increase in BS HI. The change in BS HI of compliant patients was significantly different compared to non-brace patients (p=0.004) and non-compliant patients (p<0.001). ConclusionsThree dimensional BS is an effective, radiation free, and objective means to evaluate patients treated with compressive orthotic bracing.

Pectus carinatum: the effects of orthotic bracing on pulmonary function and gradual compression on patient compliance

The treatment of pectus carinatum (PC) deformity has been considered to be operative. Some authors have shown that postoperative pulmonary function is worsened. They have suggested that compromised chest wall expansion secondary to surgery leads to compromised pulmonary function. Several authors have advocated an orthotic brace for the treatment of PC. Pulmonary functions after orthotic brace treatment have not been investigated. Between April 2006 and October 2012, 61 patients presented with PC. Orthotic braces allowing gradual compression were prepared according to the anthropometric measurements of individual patients. The brace belt was tightened gradually. The brace was worn 6 h a day during the first week and the bracing time was prolonged for an additional hour per week till 16 h per day has been reached. Pre- and post-treatment echocardiography, pulmonary function tests and thorax computed tomography (CT) were obtained. The pectus severity index (Haller index) and the angle of sternal rotation were measured using CT. Satisfaction from bracing was evaluated by parents or patients at the end of the treatment. While the mean pretreatment Haller index was 1.96 ± 0.24, the mean post-treatment index was 2.26 ± 0.32. The angle of rotation was improved by 47.5%. Forced vital capacity and forced expiratory volume in 1 second were correlated with the predicted values for age. There was no statistically significant difference between pre- and post-treatment values. No skin breakdown or bruising was encountered. The overall average satisfaction score was 3.92 ± 0.27. We conclude that pulmonary function tests are not affected after brace treatment and gradual progression of bracing increases the patient's compliance.

Hyoid Bone Advancement for Improving Airway Patency

The goal of this study was to evaluate the effect of anterior forces applied to the hyoid bone on upper airway dimensions and airflow. The study also evaluated the feasibility of applying these forces using a novel magnet-based system. Human cadaver specimens. Surgical laboratory. Five fresh cadaveric specimens were evaluated using fluoroscopy and computed tomography to examine upper airway opening as well as an airflow model to examine upper airway collapse. Anteriorly directed force was applied to the hyoid bone directly using a wire and with a magnet-based system called the Magnap device. Direct application of force was examined with an axial load frame or suspended weights. The magnet-based system applied similar forces using an internal, implanted magnet secured to the hyoid bone and an external magnet housed within an orthotic brace. A force of 2 N perpendicular to the neck skin advanced the hyoid 1 cm, opened the upper airway, and significantly improved airflow. The implanted magnet-based device generated similar forces, with similar effects on the upper airway. Application of anterior force to the hyoid bone improved upper airway dimensions and airflow in the human cadaver model. These results justify additional study to evaluate the benefits of this magnet-based system as a possible treatment of upper airway obstruction.

Magnetic Mini-Mover Procedure for pectus excavatum: II: initial findings of a Food and Drug Administration–sponsored trial

Purpose The Magnetic Mini-Mover Procedure (3MP) uses a magnetic implant coupled with an external magnet to generate force sufficient to gradually remodel pectus excavatum deformities. This is an interim report of the evolution of the 3MP during a Food and Drug Administration–approved clinical trial. Methods After obtaining Institutional Review Board approval, we performed the 3MP on 10 otherwise healthy patients with moderate to severe pectus excavatum deformities (age, 8-14 years; Haller index >3.5). Operative techniques evolved to improve ease of implantation. Patients were evaluated monthly by a pediatric surgeon and orthotist. Electrocardiograms were performed pre- and postoperatively. Sternal position was documented by pre- and postprocedure computed tomographic scan, interval chest x-ray, depth gauge, and interval photographs. Results There was no detectable effect of the static magnetic field on wound healing or cardiopulmonary function. No detectable injuries and minimal skin changes resulted from brace wear. Operative techniques evolved to include a custom sternal punch and a flexible guide wire to guide the posterior plate into position behind the sternum, reducing outpatient operating time to one-half hour. In 9 patients, the procedure was performed as an outpatient basis; and 1 patient was observed overnight. Three patients required evacuation of retained pleural air postoperatively, and 2 required an outpatient revision. A custom-fitted orthotic brace (Magnatract) was extensively modified to increase user friendliness and functionality while incorporating several novel functions: a screw displacement mechanism so patients can easily self-adjust magnetic force, a miniature data logger to measure force and temperature data every 10 minutes, and an interactive online Web portal for remote patient evaluation. All attempts to quantitate sternal position (radiographic, fluid volume, and depth gauge) were inadequate. Visual assessment remains the best indicator. Conclusions In this interim report, the 3MP appears to be a safe, minimally invasive, outpatient, cost-effective alternative treatment of pectus excavatum. Outcomes will be reported upon the completion of this phase II clinical trial.

Reforming the Belgian market for orthotic braces: What can we learn from the international experience?

This article aims to review regulation governing outpatient orthotic braces (neck, wrist and knee braces) in France, the Netherlands and Sweden with a view to reforming the Belgian market. Information about the regulatory framework was derived from an analysis of legal texts and a survey completed by national experts. Strategies to keep down prices include public procurement in Sweden, maximum prices in France, and exclusion of expensive braces from reimbursement in the Netherlands. Reimbursement is linked to a medical indication or a chronic condition in France, the Netherlands and Sweden. To gain reimbursement, the cost-effectiveness of orthotic braces needs to be demonstrated in France and the Netherlands. Orthotic braces tend to be initially prescribed by a specialist physician and distributed by orthotists, medical equipment shops and/or community pharmacies. Extensive government intervention exists in the outpatient orthotic brace market in the countries studied. Our recommendations to reform the Belgian market for prefabricated orthotic braces are to separate reimbursement for service provision from reimbursement for braces; to set prices by means of a tendering process or an international price comparison; and to make reimbursement conditional on effectiveness and cost-effectiveness of braces.