A combined musculoskeletal and finite element model of a foot to predict plantar pressure distribution.

In this study, a combined subject-specific numerical and experimental investigation was conducted to explore the plantar pressure of an individual. The research utilized finite element (FE) and musculoskeletal modelling based on computed tomography (CT) images of an ankle-foot complex and three-dimensional gait measurements. Muscle forces were estimated using an individualized multi-body musculoskeletal model in five gait phases. The results of the FE model and gait measurements for the same subject revealed the highest stress concentration of 0.48 MPa in the forefoot, which aligns with previously-reported clinical observations. Additionally, the study found that the encapsulated soft tissue FE model with hyper-elastic properties exhibited higher stresses compared to the model with linear-elastic properties, with maximum ratios of 1.16 and 1.88 MPa in the contact pressure and von-Mises stress, respectively. Furthermore, the numerical simulation demonstrated that the use of an individualized insole caused a reduction of 8.3% in the maximum contact plantar pressure and 14.7% in the maximum von-Mises stress in the encapsulated soft tissue. Overall, the developed model in this investigation holds potential for facilitating further studies on foot pathologies and the improvement of rehabilitation techniques in clinical settings.

Evaluating the clinical effects of a dynamic shoulder orthosis.

BACKGROUND: Shoulder orthoses reduce the gravitational pull on the shoulder by providing an upward force to the arm, which can decrease shoulder pain caused by stress on the glenohumeral structures. OBJECTIVE: In this interventional study, the clinical effects of a recently developed dynamic shoulder orthosis were assessed in 10 patients with chronic shoulder pain. The shoulder orthosis provides an upward force to the arm with 2 elastic bands. These bands are arranged to statically balance the arm, such that the supportive force is always directed toward the glenohumeral joint and shoulder movements are not impeded. STUDY DESIGN: Clinical effect study. METHODS: The study population was provided with a dynamic shoulder orthosis for 2 weeks. In the week before the orthosis fitting, the participants had no intervention. The primary outcome measures were the mean shoulder pain scores before and during the intervention, and the distance between the humeral head and the acromion without and with orthosis. RESULTS: Ultrasound evaluation showed that the shoulder orthosis resulted in a reduction of the distance between the acromion and humeral head at different levels of arm support. In addition, it was demonstrated that the mean shoulder pain scores (range 0-10) decreased from 3.6 to 3 (in rest) and from 5.3 to 4.2 (during activities) after 2 weeks of orthosis use. In general, patients were satisfied with the weight, safety, ease in adjusting, and effectiveness of the orthosis. CONCLUSIONS: The results of this study show that the orthosis has the potential to reduce shoulder complaints in patients with chronic shoulder pain.

Mechanical design and feasibility of a finger exoskeleton to support finger extension of severely affected stroke patients.

In this paper we presented the mechanical design and evaluation of a low-profile and lightweight exoskeleton that supports the finger extension of stroke patients during daily activities without applying axial forces to the finger. The exoskeleton consists of a flexible structure that is secured to the index finger of the user while the thumb is fixed in an opposed position. Pulling on a cable will extend the flexed index finger joint such that objects can be grasped. The device can achieve a grasp size of at least 7 cm. Technical tests confirmed that the exoskeleton was able to counteract the passive flexion moments corresponding to the index finger of a severely affected stroke patient (with an MCP joint stiffness of k = 0.63Nm/rad), requiring a maximum cable activation force of 58.8N. A feasibility study with stroke patients (n=4) revealed that the body-powered operation of the exoskeleton with the contralateral hand caused a mean increase of 46° in the range of motion of the index finger MCP joint. The patients (n=2) who performed the Box & Block Test were able to grasp and transfer maximally 6 blocks in 60 sec. with exoskeleton, compared to 0 blocks without exoskeleton. Our results showed that the developed exoskeleton has the potential to partially restore hand function of stroke patients with impaired finger extension capabilities. An actuation strategy that does not involve the contralateral hand should be implemented during further development to make the exoskeleton suitable for bimanual daily activities.

Three-dimensional correction of scoliosis by a double spring reduction system as a dynamic internal brace: a pre-clinical study in Göttingen minipigs.

BACKGROUND CONTEXT: Adolescent idiopathic scoliosis (AIS) is a major skeletal deformity that is characterized by a combination of apical rotation, lateral bending and apical lordosis. To provide full 3D correction, all these deformations should be addressed. We developed the Double Spring Reduction (DSR) system, a (growth-friendly) concept that continuously corrects the deformity through two different elements: A posterior convex Torsional Spring Implant (TSI) that provides a derotational torque at the apex, and a concave Spring Distraction System (SDS), which provides posterior, concave distraction to restore thoracic kyphosis. PURPOSE: To determine whether the DSR components are able to correct an induced idiopathic-like scoliosis and to compare correction realized by the TSI alone to correction enforced by the complete DSR implant. STUDY DESIGN/SETTING: Preclinical randomized animal cohort study. PATIENT SAMPLE: Twelve growing Göttingen minipigs. OUTCOME MEASURES: Coronal Cobb angle, T10-L3 lordosis/kyphosis, apical axial rotation, relative anterior lengthening. METHODS: All mini-pigs received the TSI with a contralateral tether to induce an idiopathic-like scoliosis with apical rotation (mean Cobb: 20.4°; mean axial apical rotation: 13.1°, mean lordosis: 4.9°). After induction, the animals were divided into two groups: One group (N=6) was corrected by TSI only (TSI only-group), another group (N=6) was corrected by a combination of TSI and SDS (DSR-group). 3D spinal morphology on CT was compared between groups over time. After 2 months of correction, animals were euthanized. RESULTS: Both intervention groups showed excellent apical derotation (TSI only-group: 15.0° to 5.4°; DSR-group: 11.2° to 3.5°). The TSI only-group showed coronal Cobb improvement from 22.5° to 6.0°, while the DSR-group overcorrected the 18.3° Cobb to -9.2°. Lordosis was converted to kyphosis in both groups (TSI only-group: -4.6° to 4.3°; DSR-group: -5.2° to 25.0°) which was significantly larger in the DSR-group (p<.001). CONCLUSIONS: The TSI alone realized strong apical derotation and moderate correction in the coronal and sagittal plane. The addition of distraction on the posterior concavity resulted in more coronal correction and reversal of induced lordosis into physiological kyphosis. CLINICAL SIGNIFICANCE: This study shows that dynamic spring forces could be a viable method to guide the spine towards healthy alignment, without fusing it or inhibiting its growth.

Feasibility of reconstructing the glenohumeral center of rotation with a single camera setup.

BACKGROUND: An accurate estimation of the glenohumeral joint center of rotation (CoR) is important during alignment of braces and exoskeletons, as a misalignment will introduce undesired forces on the human body. The aim of this research was to develop a new method to estimate the glenohumeral CoR and register the location to the body using a single camera and two printed markers. METHODS: During shoulder anteflexion, the arm roughly describes an arc in the sagittal plane, with the glenohumeral joint in the center. Two binary square-fiducial ArUco markers were secured to the upper arm and the scapula, their position and orientation were obtained, and a sphere was fitted to the coordinates of the arm marker. The sphere center position was then registered on the skin. The accuracy was assessed with a test bench with a known rotational center. The repeatability was assessed in vivo with five healthy participants. RESULTS: The mean absolute offset between the true CoR of the test bench and the fitted sphere centers across multiple trials was 2.7 mm at a velocity of 30 degrees/s, and 2.5 mm at 60 degrees/s. The root mean squared distance from the estimated sphere centers after each trial to the mean sphere center across all trials per participant was 5.1 mm on average for the novice examiner and 5.2 mm for the expert examiner. CONCLUSIONS: The proposed method is able to accurately and precisely estimate the glenohumeral CoR.

Design and feasibility of the T-GRIP thumb exoskeleton to support the lateral pinch grasp of spinal cord injury patients.

Improving the impaired hand function of spinal cord injury patients with a robotic exoskeleton can highly impact their self-management, and ultimately their quality of life. In this paper the design and evaluation of a new, lightweight (50 gram) robotic thumb exoskeleton, called TGRIP, was presented that supports the lateral pinch grasp. The mechanism consists of a linear actuator that was mounted to the dorsal side of the hand, and a force transmission mechanism that flexes the thumb towards the side of the index finger. The thumb movement was controlled through contralateral wrist rotation. Experimental results from an evaluation with three spinal cord injury patients showed that the achieved grip force (~ 7N) was higher and the overall performance during the Grasp and Release Test was better with the T-GRIP than without device. The device shows great potential for improving the hand function of patients with cervical spinal cord injury by actuating only a single degree of freedom.

Accurate Estimation of Upper Limb Orthosis Wear Time Using Miniature Temperature Loggers.

OBJECTIVE: To propose and validate a new method for estimating upper limb orthosis wear time using miniature temperature loggers attached to locations on the upper body. DESIGN: Observational study. SUBJECTS: Fifteen healthy participants. METHODS: Four temperature loggers were attached to the arm and chest with straps. Participants were asked to remove and re-attach the straps at specified time-points. The labelled temperature data obtained were used to train a decision tree classification algorithm to estimate wear time. The final performance (mean error and 95% confidence interval) of the trained classifier and the wear time estimation were assessed with a hold-out data-set. RESULTS: The trained algorithm can correctly classify unseen temperature data with a mean classification error between 1.1% and 3.1% for the arm, and between 1.8% and 4.0% for the chest, depending on the sampling time of the temperature logger. This resulted in mean wear time errors between 0.5% and 8.3% for the arm, and 0.13% and 13.0% for the chest. CONCLUSION: The proposed method based on a classifier can accurately estimate upper limb orthosis wear time. This method could enable healthcare professionals to gain insight into the wear time of any upper limb orthosis.

Vital Role of In-House 3D Lab to Create Unprecedented Solutions for Challenges in Spinal Surgery, Practical Guidelines and Clinical Case Series.

For decades, the advantages of rapid prototyping for clinical use have been recognized. However, demonstrations of potential solutions to treat spinal problems that cannot be solved otherwise are scarce. In this paper, we describe the development, regulatory process, and clinical application of two types of patient specific 3D-printed devices that were developed at an in-house 3D point-of-care facility. This 3D lab made it possible to elegantly treat patients with spinal problems that could not have been treated in a conventional manner. The first device, applied in three patients, is a printed nylon drill guide, with such accuracy that it can be used for insertion of cervical pedicle screws in very young children, which has been applied even in semi-acute settings. The other is a 3D-printed titanium spinal column prosthesis that was used to treat progressive and severe deformities due to lysis of the anterior column in three patients. The unique opportunity to control size, shape, and material characteristics allowed a relatively easy solution for these patients, who were developing paraplegia. In this paper, we discuss the pathway toward the design and final application, including technical file creation for dossier building and challenges within a point-of-care lab.

Distraction forces on the spine in early-onset scoliosis: A systematic review and meta-analysis of clinical and biomechanical literature.

Distraction-based growing rods are frequently used to treat Early-Onset Scoliosis. These use intermittent spinal distractions to maintain correction and allow for growth. It is unknown how much spinal distraction can be applied safely. We performed a systematic review and meta-analysis of clinical and biomechanical literature to identify such safety limits for the pediatric spine. This systematic review and meta-analysis was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. Three systematic searches were performed including in-vivo, ex-vivo and in-silico literature. Study quality was assessed in all studies and data including patient- or specimen characteristics, distraction magnitude and spinal failure location and ultimate force at failure were collected. Twelve studies were included, 6 in-vivo, 4 ex-vivo and 2 in-silico studies. Mean in-vivo distraction forces ranged between 242 and 621 N with maxima of 422-981 N, without structural failures when using pedicle screw constructs. In the ex-vivo studies (only cervical spines), segment C0-C2 was strongest, with decreasing strength in more distal segments. Meta-regression analysis demonstrated that ultimate force at birth is 300-350 N, which increases approximately 100 N each year until adulthood. Ex-vivo and in-silico studies showed that yielding occurs at 70-90% of ultimate force, failure starts at the junction between endplate and intervertebral disc, after which the posterior- and anterior long ligament rupture. While data on safety of distraction forces is limited, this systematic review and meta-analysis may aid in the development of guidelines on spinal distraction and may benefit the development and optimization of contemporary and future distraction-based technologies.

Induction of a representative idiopathic-like scoliosis in a porcine model using a multidirectional dynamic spring-based system.

BACKGROUND CONTEXT: Scoliosis is a 3D deformity of the spine in which vertebral rotation plays an important role. However, no treatment strategy currently exists that primarily applies a continuous rotational moment over a long period of time to the spine, while preserving its mobility. We developed a dynamic, torsional device that can be inserted with standard posterior instrumentation. The feasibility of this implant to rotate the spine and preserve motion was tested in growing mini-pigs. PURPOSE: To test the quality and feasibility of the torsional device to induce the typical axial rotation of scoliosis while maintaining growth and mobility of the spine. STUDY DESIGN: Preclinical animal study with 14 male, 7 month old Gottingen mini-pigs. Comparison of two scoliosis induction methods, with and without the torsional device, with respect to 3D deformity and maintenance of the scoliosis after removal of the implants. METHODS: Fourteen mini-pigs received either a unilateral tether-only (n=6) or a tether combined with a contralateral torsional device (n=8). X-rays and CT-scans were made post-operative, at 8 weeks and at 12 weeks. Flexibility of the spine was assessed at 12 weeks. In 3 mini-pigs per condition, the implants were removed and the animals were followed until no further correction was expected. RESULTS: At 12 weeks the tether-only group yielded a coronal Cobb angle of 16.8±3.3°For the tether combined with the torsional device this was 22.0±4.0°. The most prominent difference at 12 weeks was the axial rotation with 3.6±2.8° for the tether-only group compared to 18.1±4.6° for the tether-torsion group. Spinal growth and flexibility remained normal and comparable for both groups. After removal of the devices, the induced scoliosis reduced by 41% in both groups. There were no adverse tissue reactions, implant complications or infections. CONCLUSION: The present study indicates the ability of the torsional device combined with a tether to induce a flexible idiopathic-like scoliosis in mini-pigs. The torsional device was necessary to induce the typical axial rotation found in human scoliosis. CLINICAL SIGNIFICANCE: The investigated torsional device could induce apical rotation in a flexible and growing spine. Whether this may be used to reduce a scoliotic deformity remains to be investigated.

Improving Hands-free Speech Rehabilitation in Patients With a Laryngectomy: Proof-of-Concept of an Intratracheal Fixation Device.

Permanent hands-free speech with the use of an automatic speaking valve (ASV) is regarded as the optimal voice rehabilitation after total laryngectomy. Due to fixation problems, regular ASV use in patients with a laryngectomy is limited. We have developed an intratracheal fixation device (ITFD) composed of an intratracheal button augmented by hydrophilic foam around its shaft. This study evaluates the short-term effectiveness and experienced comfort of this ITFD during hands-free speech in 7 participants with a laryngectomy. We found that 4 of 7 participants had secure ASV fixation inside the tracheostoma during hands-free speech for at least 30 minutes with the ITFD. The ITFD's comfort was perceived positively overall. The insertion was perceived as being mildly uncomfortable but not painful. This proof-of-concept study demonstrates the feasibility of the ITFD that might improve stomal attachment of ASVs, and it provides the basis for further development toward a prototype suitable for long-term daily use.

Can 3D-printing avoid discomfort-related implant removal in midshaft clavicle fractures? A four-year follow-up.

INTRODUCTION: Due to the variation in shape and curvature of the clavicle, plates often have to be adjusted during surgery to acquire a good fit. Poorly fitted plates can cause discomfort, eventually requiring implant removal. 3D-printed replicas of the fractured clavicle can assist in planning of the surgical approach, plate selection and, if necessary, adjustment of the plate prior to surgery. We hypothesized this method of preoperative preparation would reduce implant-related discomfort resulting in a reduced reoperation rate MATERIALS AND METHODS: In a prospective cohort study, perioperative plate handling and clavicle fixation were timed and follow-up data were collected from participants undergoing operative treatment for a midshaft clavicle fracture. The control group (n = 7) received conventional surgery with standard precontoured plates. For the intervention group (n = 7), 3D-printed replicas of the fractured clavicle and a mirrored version of the healthy contralateral clavicle were available prior to surgery for planning of the surgical approach, and for plate selection and contouring. Primary outcome was reoperation rate due to implant-related discomfort. Secondary outcomes were complications and time differences in the different surgical phases (reduction, fixation and overall operation time) RESULTS: More participants in the control group had the plate removed due to discomfort compared to the intervention group (5/7 vs. 0/6; P = 0.012). One participant was excluded from the intervention group due to a postoperative complication; an infection occurred at the implant site. No relevant time difference in surgical plate handling was found between both groups. CONCLUSIONS: Preoperative preparation using 3D-printed replicas of the clavicle fracture may reduce implant removal caused by plated-related discomfort. No relevant effect on surgery time was found. TRIAL REGISTRATION: Registered with 'toetsingonline.nl', trial number NL51269.075/14, 17-02-2015.

A New Shoulder Orthosis to Dynamically Support Glenohumeral Subluxation.

OBJECTIVE: In this paper we presented a novel shoulder subluxation support that aims to reduce the stress on the passive structures around the shoulder of patients with glenohumeral subluxation and glenohumeral-related shoulder pain. The device applies a force to the upper arm without impeding the functional range of motion of the arm. Our design contains a mechanism that statically balances the arm with two elastic bands. METHODS: A technical evaluation study was conducted to assess the performance of the orthosis. Additionally, two patients evaluated the orthosis. RESULTS: The results of the technical validation confirm the working of the balancing mechanism. The pilot study demonstrated that the shoulder support increased the feeling of stability of the shoulder joint and, to a lesser extent, decreased shoulder pain. Furthermore, both patients reported that the orthosis did not impede their range of motion. CONCLUSION: In this research we developed a shoulder orthosis based on two statically balanced springs that support the shoulder of patients with glenohumeral subluxation that have residual shoulder muscle force. Compared to existing shoulder supports, our design does not impede the range of motion of the arm, and continues to provide a stabilizing force to the shoulder, even if the arm is moved away from the neutral position. Tests with two participants showed promising results. SIGNIFICANCE: The device presented in this work could have a significant impact on the shoulder function which may improve rehabilitation outcome and improve the quality of life of patients suffering from glenohumeral subluxation and shoulder pain.

Evaluation of intuitive trunk and non-intuitive leg sEMG control interfaces as command input for a 2-D Fitts's law style task.

Duchenne muscular dystrophy (DMD) is a muscular condition that leads to muscle loss. Orthotic devices may present a solution for people with DMD to perform activities of daily living (ADL). One such device is the active trunk support but it needs a control interface to identify the user's intention. Myoelectric control interfaces can be used to detect the user's intention and consequently control an active trunk support. Current research on the control of orthotic devices that use surface electromyography (sEMG) signals as control inputs, focuses mainly on muscles that are directly linked to the movement being performed (intuitive control). However in some cases, it is hard to detect a proper sEMG signal (e.g., when there is significant amount of fat), which can result in poor control performance. A way to overcome this problem might be the introduction of other, non-intuitive forms of control. This paper presents an explorative study on the comparison and learning behavior of two different control interfaces, one using sEMG of trunk muscles (intuitive) and one using sEMG of leg muscles that can be potentially used for an active trunk support (non-intuitive). Six healthy subjects undertook a 2-D Fitts's law style task. They were asked to steer a cursor into targets that were radially distributed symmetrically in five directions. The results show that the subjects were generally able to learn to control the tasks using either of the control interfaces and improve their performance over time. Comparison of both control interfaces demonstrated that the subjects were able to learn the leg control interface task faster than the trunk control interface task. Moreover, the performance on the diagonal-targets was significantly lower compared to the one directional-targets for both control interfaces. Overall, the results show that the subjects were able to control a non-intuitive control interface with high performance. Moreover, the results indicate that the non-intuitive control may be a viable solution for controlling an active trunk support.

Exploring physiological signals on people with Duchenne muscular dystrophy for an active trunk support: a case study.

BACKGROUND: Arm support devices are available to support people with Duchenne muscular dystrophy (DMD), but active trunk support devices are lacking. An active trunk support device can potentially extend the reach of the arm and stabilize the unstable trunk of people with DMD. In a previous study, we showed that healthy people were able to control an active trunk support using four different control interfaces (based on joystick, force on feet, force on sternum and surface electromyography). All four control interfaces had different advantages and disadvantages. The aim of this study was to explore which of the four inputs is detectably used by people with DMD to control an active trunk support. RESULTS: The results were subject-dependent in both experiments. In the active experiment, the joystick was the most promising control interface. Regarding the static experiment, surface electromyography and force on feet worked for two out of the three subjects. CONCLUSIONS: To our knowledge, this is the first time that people with DMD have engaged in a control task using signals other than those related to their arm muscles. According to our findings, the control interfaces have to be customised to every DMD subject.

Ten cold clubfeet.

Background and purpose - Idiopathic clubfeet are commonly treated with serial manipulation and casting, known as the Ponseti method. The use of Plaster of Paris as casting material causes both exothermic and endothermic reactions. The resulting temperature changes can create discomfort for patients. Patients and methods - In 10 patients, we used a digital thermometer with a data logger to measure below-cast temperatures to create a thermal profile of the treatment process. Results - After the anticipated temperature peak, a surprisingly large dip was observed (Tmin = 26 °C) that lasted 12 hours. Interpretation - Evaporation of excess water from a cast might be a cause for discomfort for clubfoot patients and subsequently, their caregivers.

Analysis of tracheostoma morphology.

OBJECTIVES: Existing fixation methods of automatic speaking valves (ASVs) suffer from shortcomings which partly are the result of insufficient conformity of the intratracheal fixation method's shape to the tracheostoma anatomy. However, quantitative data are lacking and will be helpful to analyse solutions for airtight fixation. This article provides such data. PATIENTS AND METHODS: The tracheostoma morphology was measured in computerized tomography scans of 20 laryngectomized patients. Measured were transverse and sagittal diameters, transition angle between skin level and tracheostoma lumen and between the tracheostoma lumen to the trachea, TE valve placement and stoma depth. RESULTS: The mean transverse and sagittal diameters of the stoma at the peristomal lip are 19.2 mm [standard deviation (SD 5.2 mm)] and 17.6 mm (SD 5.3 mm), respectively. The mean transition angles are 84.5° (SD 15.6°) at skin level and 153.6° (SD 11.7°) into the trachea. The mean distance between TE valve and peristomal lip is 13.5 mm (SD 7.0 mm). The mean stoma depth is 14.0 mm (SD 6.4 mm). CONCLUSIONS: Due to the large variation, no 'average tracheostoma morphology', suitable for shaping a generic intratracheal fixation device, can be defined. Therefore, providing an airtight fixation in each patient would require a large range of different sizes, customization or a new approach.

Spinal shape modulation in a porcine model by a highly flexible and extendable non-fusion implant system.

PURPOSE: In vivo evaluation of scoliosis treatment using a novel approach in which two posterior implants are implanted: XSLAT (eXtendable implant correcting Scoliosis in LAT bending) and XSTOR (eXtendable implant correcting Scoliosis in TORsion). The highly flexible and extendable implants use only small, but continuous lateral forces (XSLAT) and torques (XSTOR), thereby allowing growth and preventing fusion. METHODS: Since (idiopathic) scoliosis does not occur spontaneously in animals, the device was used to induce a spinal deformity rather than correct it. Six of each implants were tested for their ability to induce scoliotic deformations in 12 growing pigs. Each implant spanned six segments and was attached to three vertebrae using sliding anchors. Radiological and histological assessments were done throughout the 8-week study. RESULTS: In all animals, the intended deformation was accomplished. Average Cobb angles were 19° for XSLAT and 6° for XSTOR. Average apical spinal torsion was 0° for XSLAT and 9° for XSTOR. All instrumented segments remained mobile and showed 20 % growth. Moderate degeneration of the facet joints was observed and some debris was found in the surrounding tissue. CONCLUSIONS: The approach accomplished the intended spinal deformation while allowing growth and preventing fusion.