Effectiveness of robotic exoskeletons for improving gait in children with cerebral palsy: A systematic review.

BACKGROUND: Robotic exoskeletons have been developed to assist locomotion and address gait abnormalities in children with cerebral palsy (CP). These wearable assistive devices provide powered assistance to the lower-extremity joints, as well as support and stability. RESEARCH QUESTION: Does exoskeleton-assisted walking improve gait in children with CP? METHODS: The PRISMA guidelines were used to conduct this systematic review. Articles were obtained in a search of the following electronic databases: Embase, CINAHL Complete, PubMed, Web of Science and MEDLINE. Studies investigating spatiotemporal, kinematic, kinetic, muscle activity and/or physiological parameters during exoskeleton-assisted walking in children with CP were included. All articles were assessed for methodological quality using an adapted version of the Quality Assessment Tool for Before-After (Pre-Post) Studies with No Control Group, provided by the National Institutes of Health (NIH). RESULTS: Thirteen studies were included. They involved the use of the following exoskeletons: tethered knee exoskeleton, pediatric knee exoskeleton (P.REX), untethered ankle exoskeleton, WAKE-Up ankle module, WAKE-Up ankle & knee module and unilateral ankle exosuit. Methodological quality varied, with key limitations in sample size and allocated time to adapt to the exoskeleton. There was a consensus that robotic exoskeletons improve gait given careful optimisation of exoskeleton torque and sufficient exoskeleton practice time for each participant. Improvements in gait included reduced metabolic cost of walking, increased walking speed, and increased knee and hip extension during stance. Furthermore, exoskeletons with an actuated ankle module were shown to promote normal ankle rocker function. SIGNIFICANCE: Robotic exoskeletons have the potential to improve the mobility of CP children and may therefore increase community participation and improve quality of life. Future work should involve larger controlled intervention studies utilising robotic exoskeletons to improve gait in children with CP. These studies should ensure sufficient exoskeleton practice time for each participant.

Rehabilitation Supported by Technology: Protocol for an International Cocreation and User Experience Study.

BACKGROUND: Living labs in the health and well-being domain have become increasingly common over the past decade but vary in available infrastructure, implemented study designs, and outcome measures. The Horizon 2020 Project Virtual Health and Wellbeing Living Lab Infrastructure aims to harmonize living lab procedures and open living lab infrastructures to facilitate and promote research activities in the health and well-being domain in Europe and beyond. This protocol will describe the design of a joint research activity, focusing on the use of innovative technology for both rehabilitation interventions and data collection in a rehabilitation context. OBJECTIVE: With this joint research activity, this study primarily aims to gain insight into each living lab's infrastructure and procedures to harmonize health and well-being living lab procedures and infrastructures in Europe and beyond, particularly in the context of rehabilitation. Secondarily, this study aims to investigate the potential of innovative technologies for rehabilitation through living lab methodologies. METHODS: This study has a mixed methods design comprising multiple phases. There are two main phases of data collection: cocreation (phase 1) and small-scale pilot studies (phase 2), which are preceded by a preliminary harmonization of procedures among the different international living labs. An intermediate phase further allows the implementation of minor adjustments to the intervention or protocol depending on the input that was obtained in the cocreation phase. A total of 6 small-scale pilot studies using innovative technologies for intervention or data collection will be performed across 4 countries. The target study sample comprises patients with stroke and older adults with mild cognitive impairment. The third and final phases involve Delphi procedures to reach a consensus on harmonized procedures and protocols. RESULTS: Phase 1 data collection will begin in March 2022, and phase 2 data collection will begin in June 2022. Results will include the output of the cocreation sessions, small-scale pilot studies, and advice on harmonizing procedures and protocols for health and well-being living labs focusing on rehabilitation. CONCLUSIONS: The knowledge gained by the execution of this research will lead to harmonized procedures and protocols in a rehabilitation context for health and well-being living labs in Europe and beyond. In addition to the harmonized procedures and protocols in rehabilitation, we will also be able to provide new insights for improving the implementation of innovative technologies in rehabilitation. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/34537.

A digital workflow for personalized design of the interface parts integrated in a powered ankle foot orthosis (PAFO).

The use of actuated exoskeletons in gait rehabilitation increased significantly in recent years. Although most of these exoskeletons are produced with a generic cuff, at the foot and ankle there are a lot of bony prominences and a limited amount of soft tissue, making it less comfortable . Furthermore, a proper alignment of the actuation systems is essential for the correct functioning of the exoskeleton. Therefore, we propose a digital workflow for the design of bespoke cuffs as interface parts of a powered ankle foot orthoses (PAFO). Moreover, this digital workflow permits the creation of axis and points of reference for the anatomical features which allows not only for the creation of custom-made cuffs but also for the integration and alignment of the PAFO mechanical components and actuation unit.

Using a texture analyser to objectively quantify foot orthoses.

BACKGROUND AND AIM: Foot orthoses alter the kinematics and kinetics in gait. With the increasing importance of evidence based practice and with the permanent development of subtractive manufacturing and introduction of additive manufacturing, there is a growing need for quantification of orthoses parameters. We describe a measurement method and protocol to quantify different parameters of a foot orthosis. TECHNIQUE: A texture analyser is used to impose a displacement of the surface of the orthosis, while the applied force is measured. The measured points are determined based on the location of anatomical landmarks on the foot. Out of the measured data, parameters are calculated representing the stiffness, compression set and shape. DISCUSSION: To illustrate the proposed technique, five different parameters are extracted from three example orthoses. Results show the added value of the proposed technique as the parameters are not only defined by the material but also by the shape.

Evaluation of the influence of cyclic loading on a laser sintered transtibial prosthetic socket using Digital Image Correlation (DIC).

People with a transtibial amputation worldwide rely on their prosthetic socket to regain their mobility. Patient comfort is largely affected by the weight and strength of these prosthetic sockets. The use of additive manufacturing could give the prosthetist a range of new design possibilities when designing a prosthetic socket. These new design possibilities can in turn lead to improved socket designs and more comfortable prosthetic sockets. This new way of designing and producing prosthetic sockets radically differs from the manual traditional production process. This makes it difficult for prosthetists to understand how all these new design possibilities influence the mechanical properties of the additive manufactured prosthetic socket. Therefore there is a growing need for a method to evaluate the strength and stiffness of newly developed socket designs.We propose a method to evaluate the strength and stiffness of prosthetic sockets. A robotic gait simulator is used to apply realistic kinetics of amputee gait to the tested socket. A Digital Image Correlation (DIC) system is then used to measure the deformation of a prosthetic socket under different loading conditions. This way it is possible to check if plastic deformation will occur in the designed transtibial socket. Furthermore it is possible to assess the effect of cyclic loading on the 3D printed socket.To illustrate the proposed method, a transtibial prosthetic socket was designed using CAD software and produced with laser sintering PA12. DIC measurements were performed on this transtibial socket both before and after it was subjected to a cyclic load of 1 million cycles (mimicking realistic amputee gait).

Gait assessment during the initial fitting of customized selective laser sintering ankle foot orthoses in subjects with drop foot.

BACKGROUND: Recently, additive fabrication has been proposed as a feasible engineering method for manufacturing of customized ankle foot orthoses (AFOs). Consequently, studies on safety, comfort and effectiveness are now carried out to assess the performance of such devices. OBJECTIVE: Evaluate the clinical performance of customized (selective laser sintering) SLS-AFOs on eight subjects with unilateral drop foot gait and compare to clinically accepted (polypropylene) PP-AFOs. STUDY DESIGN: Active control trial. METHODS: For each subject two customized AFOs were fabricated: one SLS-AFO manufactured following an additive fabrication framework and one thermoplastic PP-AFO manufactured according to the traditional handcraft method. Clinical performance of both AFOs was evaluated during gait analysis. RESULTS: A significant beneficial effect of both custom-moulded PP-AFO and customized SLS-AFO in terms of spatial temporal gait parameters and ankle kinematic parameters compared to barefoot gait of adults with drop foot gait are observed. No statistically significant difference between the effect of PP-AFO and of SLS-AFO was found in terms of spatial temporal gait parameters and ankle kinematic parameters. CONCLUSION: AFOs manufactured through the SLS technique show performances that are at least equivalent to the handcrafted PP-AFOs commonly prescribed in current clinical practice. Clinical relevance Manufacturing personalized AFOs with selective laser sintering (SLS) in an automated production process results in decreased production time and guarantees the consistency of shape and functional characteristics over different production time points compared to the traditional manufacturing process. Moreover, it reduces the dependency of the appliance on the experience and craftsmanship of the orthopaedic technician.

Influence of implant design on the biomechanical environment of immediately placed implants: computed tomography-based nonlinear three-dimensional finite element analysis.

PURPOSE: To evaluate the influence of different implant designs on the biomechanical environment of immediately placed implants. MATERIALS AND METHODS: Computed tomography (CT)-based finite element models comprising a maxillary central incisor socket and four commercially available internal-connection implants (SIN SW, 3i Certain, Nobel Replace, and ITI Standard) of comparable diameters and lengths were constructed. Biomechanical scenarios of immediate placement, immediate loading, and delayed loading protocols were simulated. Analysis of variance at the 95% confidence level was used to evaluate peak equivalent strain (EQV strain) in bone and bone-to-implant relative displacement. RESULTS: Loading magnitude (77.6%) and the clinical situation (15.0%) (ie, presence or absence of an extraction socket defect, condition of the bone-to-implant interface) presented the highest relative contributions to the results. Implant design contributed significantly to strains and displacements in the immediate placement protocol. Whereas a greater contribution of implant design was observed for strain values and distributions for immediately placed and immediately loaded protocols, a smaller contribution was observed in the delayed loading scenario. CONCLUSION: Implant design contributes significantly to changing biomechanical scenarios for immediately placed implants. The results also suggest that avoiding implant overloading and ensuring high primary implant stability are critical in encouraging the load-bearing capability of immediately placed implants.

Influência do platform-switching no ambiente biomecânico de implantes em áreas estéticas – análise 3D em elementos finitos / Influence of platform-switching on the biomechanical environment of implant in esthetical zones – a 3D finite element analysis

O objetivo deste trabalho é avaliar a influencia do platform- switching nas deformações do osso peri-implantar e nas tensões do parafuso passante de implantes em áreas estéticas. Modelos em elementos finitos de um alvéolo de extração de um incisivo central superior, de um implante com 13 mm de comprimento por 4,5 de plataforma e de abutments com 4,5, 4,0 e 3,5 mm foram construídos. Os abutments de 4,0 e 3,5 mm acarretaram uma desadaptação horizontal de 0,5 e 1,0 mm (platform-switching), respectivamente. Um carregamento de 100 N foi aplicado sobre os abutments. Uma melhor distribuição de deformações no osso marginal peri-implantar são encontradas nos designes em platform-switching. Por outro lado, uma maior concentração de tensões no parafuso da prótese deve ser esperada para esta configuração.

The purpose of this study is to evaluate the influence of platform-switching configuration on the strain in periimplant bone and on the stress in the abutment screw. CT-based finite element models comprising an upper central incisor socket, a 13-mm implant with 4,5 mm of shoulder diameter and abutments of 4.5, 4.0 and 3.5 mm diameter were constructed. The abutments de 4.0 and 3.5 mm diameter represent the horizontal mismatch of 0.5 and 1.0 mm (platform-switching), respectively. 100 N magnitude load was applied over the abutments. A better strain distribution in periimplant marginal bone was encountered in platform- switching designs. On the other hand, a higher stress concentration could be found in the abutment screw.

Influence of implant connection type on the biomechanical environment of immediately placed implants - CT-based nonlinear, three-dimensional finite element analysis.

PURPOSE: The purpose of the present study was to evaluate the biomechanical environment of immediately placed implants, before and after osseointegration, by comparing three different implant-abutment connection types. MATERIALS AND METHODS: A computer tomography-based finite element model of an upper central incisor extraction socket was constructed containing implants with either external hex, internal hex, or Morse-taper connection. Frictional contact elements were used in the bone, implant, abutment, and abutment screw interfaces in the immediately placed simulations. In osseointegrated simulations, the repair of bone alveolar defect and a glued bone-to-implant interface were assumed. By analysis of variance, the influence was assessed of connection type, clinical situation, and loading magnitude on the peak equivalent strain in the bone, peak von Mises stress in the abutment screw, bone-to-implant relative displacement, and abutment gap. RESULTS: The loading magnitudes had a significant contribution, regardless of the assessed variable. However, the critical clinical situation of an immediately placed implant itself was the main factor affecting the peak equivalent strain in the bone and bone-to-implant displacement. The largest influence of the connection type in this protocol was seen on the peak equivalent stress in the abutment screw. On the other hand, a higher influence of the various connection types on bone stress/strain could be noted in osseointegrated simulations. CONCLUSIONS: The implant-abutment connection design did not significantly influence the biomechanical environment of immediately placed implants. Avoiding implant overloading and ensuring a sufficient initial intraosseous stability are the most relevant parameters for the promotion of a safe biomechanical environment in this protocol.

Influência do desenho do implante na micromovimentação de implantes imediatos com carga imediata: análise multivariada em elementos finitos / Influence of implant design on the micromovement of immediately placed and loaded implants: a multivariate finite element analysis

O objetivo deste trabalho foi avaliar a influência do desenho do implante nas micromovimentações de implantes imediatos com carga imediata. Modelos em elementos finitos de um alvéolo de extração de um incisivo central superior e quatro desenhos de implantes de conexão interna, disponíveis comercialmente (SIN SW®, 3i Certain®, Nobel ReplaceTM e RN synOcta® ITI Standard), com diâmetros e comprimentos semelhantes foram construídos. Cargas de 50, 100 e 200 N foram aplicadas sobre os implantes. ANOVA com nível de 95% de significância foi utilizada para avaliar os dados da micromovimentação dos implantes. O design do implante influencia significativamente (31,21%) a micromovimentação de implantes imediatos com carga imediata. Não obstante, a intensidade da carga aplicada (68,80%) é o fator mais importante na estabilidade dos implantes neste protocolo.

The purpose of this paper was to evaluate the influence of different implant designs on the micromovements of immediately placed implants. CT-based finite element models comprising an upper central incisor socket and four commercially available internal connection implant designs (SIN SW®, 3i Certain®, Nobel ReplaceTM, and RN synOcta® ITI Standard) of comparable diameter and length were constructed. 50, 100 and 200N magnitude loads were applied over the implant. ANOVA at 95% level of significance was used to evaluate bone to implant relative displacement (micromovements). The implant design (68,80%) greatly influences the micromovement of immediately placed implants. However, the loading magnitude (68,80%) is the most important factor regarding the implant stability in this protocol.

Avaliação biomecânica de implantes imediatos com carga imediata: análise 3D em elementos finitos / Biomechanical evaluation of immediately placed implants: CT-based 3D finite element analysis

Objetivo: o objetivo do presente estudo foi analisar o ambiente biomecânico de implantes imediatos com carga imediata, comparando 3 diferentes magnitudes de carga. Material e Métodos: um modelo em elementos finitos de um incisivo central superior contendo um implante cônico de 13 mm de comprimento e 4,5 mm de plataforma, hexágono interno, foi construído. Elementos de contato friccional foram utilizados para simular as interfaces entre o osso, implante, abutment e parafuso do abutment. Foram aplicadas forças de 50, 100 e 200 N na extremidade superior do abutment. Os dados para a deformação equivalente no osso, as tensões equivalentes no parafuso, deslocamento relativo osso-implante e gap do abutment foram calculados. Resultados/Conclusão: a magnitude das cargas aplicadas sobre os implantes imediatos com carga imediata influenciam significativamente o ambiente biomecânico deste protocolo.

Objective: the purpose of the present study was to evaluate the biomechanical environment of immediately placed implants, by comparing three different loading magnitudes. Material and Methods: a CT-based finite element model of an upper central incisor extraction socket was constructed containing a conical internal hex 13-mm implant. Frictional contact elements were used in the bone, implant, abutment and abutment screw interfaces. Forces of 50, 100 and 200 N were applied on the superior central region of the abutment. Data for the peak equivalent strain in the bone, peak Von Mises stress in the abutment screw, bone-to-implant relative displacement and abutment gap were calculated. Results/Conclusion: the loading magnitudes applied over the implants are capable to greatly influence the biomechanical environment in immediately placed protocol.