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Wearable exoskeletons are emerging as a new tool for gait training. However, comparisons between exoskeletons and conventional orthoses in terms of safety and feasibility are scarce. This study assessed the safety, feasibility, usability, and learning process of using the ABLE Exoskeleton in people with spinal cord injury (SCI) while comparing it with knee-ankle-foot orthoses (KAFOs). In this randomized, crossover clinical trial, 10 patients with chronic complete SCI (T4-T12) conducted a 10-session training and assessment protocol with each device: KAFOs and the ABLE Exoskeleton. Outcomes on safety (adverse events), and feasibility and usability (level of assistance, donning/doffing, therapy activities) were recorded for both devices. Evaluation sessions included standard clinical tests (Timed Up and Go, 10-Meter Walk Test, and 6-Minute Walk Test) to assess gait performance. The therapy metrics (number of steps, distance, gait speed, and standing and walking time) were recorded at each session for the robotic device. Participants quickly learned how to use the ABLE Exoskeleton, showing improvements in all therapy metrics (p<0.05) and the 6-Minute Walk Test (p<0.05). Participants reported less adverse events with the robotic device than KAFOs (17 and 31, respectively). Total donning and doffing time was 43 s faster with the robotic device using comparable levels of assistance. The time to complete the therapy activities was very similar between devices. Overall, participants needed 1 to 4 training sessions to perform essential therapy activities (sit/stand transitions, walking 10 meters, turning around) with both devices using minimum assistance or less. The results of this study show that it is feasible and safe for people with motor complete paraplegia due to SCI (T4-T12) to use the ABLE Exoskeleton for gait training in a rehabilitation hospital setting. The ABLE Exoskeleton proved to be as practical and easy to use as conventional orthoses, with fewer AEs reported when using the exoskeleton versus the KAFOs.

●A systematic review was performed on studies utilizing 3D printed orthoses for musculoskeletal conditions of the elbow, wrist, hand and digits in clinical settings.●The 10 studies included in this systematic review report on actual patient use of 3D printed orthoses.●The 3D printing process of orthoses for the upper extremity remains complex and under-utilized.●There is a need for more clinical trials to study the benefits of 3D printed orthoses compared with custom made low temperature thermoplastic orthoses for patients in the hand therapy setting. Systematic Review 3D printed orthoses are emerging as a possible option in the field of hand therapy to fabricate conventional casts and orthoses. It is unknown how this technology is currently being used to treat upper extremity musculoskeletal conditions, and if 3D orthoses are comparable to custom- made low temperature thermoplastic orthoses fabricated by hand therapists. The primary aim of this review was to investigate the utilization, effectiveness and feasibility of 3D printed technology to manufacture custom orthoses for musculoskeletal conditions of the upper extremity. Studies describing 3D printed orthoses or casts used in treatment with patients were included following a comprehensive literature search using CINAHL, PubMed, Medline, ProQuest, and EBSCO databases. The selected studies had to address musculoskeletal conditions of the elbow, wrist, hand and/or digits that would typically be immobilized with a cast or brace or orthotic or orthosis. Ten studies met the inclusion criteria. Study designs included case studies, case series, and 1 randomized clinical trial. 3D printed orthoses/casts appear to be comfortable, provide adequate immobilization, and have pleasing aesthetics. However, expensive equipment, lack of appropriate software and scanning tools and lack of highly skilled clinicians are all factors preventing the implementation of 3D printed orthoses into current clinical practice. 3D printed orthoses appear to be effective at immobilization of a limb, aesthetically pleasing, and utilize lightweight and well -ventilated materials. However, the feasibility of implementing 3D printing technology in hand therapy settings remains challenging in part due to the resources required. While 3D printing shows promise, the high cost of equipment, lack of training and skill of clinicians and the long time required for production are all factors that need to be improved to make 3D printing a viable option in the hand therapy setting.

Three-dimensional (3D) printing offers an alternative for orthotic fabrication, particularly where thermoplastics are costly or not readily available. This report explored a universal-design 3D-printed relative motion orthosis and compared short-term user satisfaction with custom thermoplastic tape (Orficast) relative motion flexion orthoses. To design and produce universal 3D-printed relative motion orthosis using iterative prototyping and compare it with custom thermoplastic tape relative motion flexion orthoses. Comparative field test with iterative prototype development. The study had two phases. In phase 1, a universal-design 3D relative motion orthosis was developed using repeated design–print–fit–refine cycles with feedback from an expert focus group. In phase 2, patients with Burton stage I boutonnière deformity were randomly assigned to wear either a 3D-printed relative motion flexion orthosis or a custom thermoplastic tape relative motion flexion orthosis for 1 week. User satisfaction was evaluated using the Turkish version of the Orthotics Prosthetics Users Survey (OPUS) satisfaction module. Four prototypes and two final designs were produced; the final design met the focus-group checklist criteria. Forty participants were randomized (20 per group); nonadherence by four 3D group participants resulted in exclusion, leaving 16 (3D printed orthoses) and 20 (thermoplastic orthoses) for analysis (n = 36). OPUS Satisfaction scores did not differ significantly between groups after 1 week (3D printed orthoses: 93.19 ± 6.28 vs thermoplastic orthoses: 89.35 ± 11.17; p = 0.24). The material cost was €2.75 (US$3.19) for the 3D-printed orthosis vs €7.50 (US$8.70) for the thermoplastic tape orthosis in our setting. In this study 3D printing lowered material costs and reduced therapist time compared to custom thermoplastic tape relative motion flexion orthoses. Patients with stage 1 Burton boutonniere deformity wearing the 3D-printed or custom thermoplastic tape relative motion flexion orthoses reported comparable satisfaction after 1-week wear time. •Development of a universal 3D printed relative motion orthosis.•Use of a focus group to develop the universal 3D relative motion orthosis.•Field testing 3D and thermoplastic tape orthoses in patients with boutonniere deformity.

Cerebral Palsy (CP) is a neurological disorder that affects motor function and causes gait abnormalities in children. Ankle–Foot Orthoses (AFOs) are external aiding devices that provide stability and improve mobility for pediatrics. However, conventional AFO materials often fail to achieve an optimal balance of strength, flexibility, and energy absorption for dynamic movements. This study introduces a novel composite material for pediatric ankle–foot orthoses (AFOs), based on Orthocryl and reinforced with multi-walled carbon nanotubes (MWCNTs) and polylactic acid (PLA). The proposed formulation is engineered to overcome the limitations of conventional materials by providing enhanced mechanical performance and improved functional suitability for clinical applications. Four composite concentrations were fabricated: pure Orthocryl, 0.5% MWCNTs, 0.5% MWCNTs/1.0% PLA, and 0.5% MWCNTs/1.5% PLA. Mechanical and morphological characterizations were performed using a universal testing machine for tensile, flexural, and impact testing, Fourier Transform Infrared Spectroscopy (FT-IR) for material composition analysis, and Field Emission Scanning Electron Microscopy (FE-SEM) for surface morphology examination. To simulate practical application, Finite Element Analysis was performed using ANSYS software, recognizing gait loading conditions. The experimental findings demonstrated that incorporating 0.5% MWCNT into Orthocryl significantly enhanced its mechanical properties, with a 12.5% increase in tensile strength (from 52.79 to 59.4 MPa), a 59.3% increase in flexural strength (from 52.08 to 82.93 MPa), and a 22% improvement in impact resistance (from 28.12 to 34.3 kJ/m 2 ). These improvements confirm the effectiveness of MWCNT reinforcement. Additionally, FE-SEM and FT-IR analyses confirmed the uniform distribution of CNTs within the matrix and stronger interfacial bonding between the filler and polymer. Simulation results showed that the 0.5% MWCNT/1.5% PLA composite had the highest deformation (10.95 mm) with a safety factor of 1.12, indicating acceptable safety. In contrast, the 0.5% MWCNT composite showed the lowest deformation (4.17 mm), 12.6% less than pure Orthocryl, and the highest safety factor (3.2), reflecting an optimal balance of strength and flexibility for pediatric AFOs in CP patients.

•Tips and tricks for fabrication of the relative motion (RM) orthoses•Fabrication simplification•Ideas for immediate clinical use Relative Motion (RM) orthoses are an extremely important and beneficial intervention in hand rehabilitation. They can be used for a variety of hand conditions including for positioning, protection, alignment and exercise. In order to achieve the intended goals of this orthotic intervention, the clinician must pay attention to detail during its fabrication. The purpose of this manuscript is to offer some simple and practical fabrication tips for hand therapists who want to include the use of RM orthoses to manage these different clinical conditions. Photos are provided to reinforce some of the key concepts.

ObjectivesTo test (i) if greater foot pronation (measured as midfoot width mobility) is associated with better outcomes with foot orthoses treatment, compared with hip exercises and (ii) if hip exercises are superior to foot orthoses, irrespective of midfoot width mobility.MethodsA two-arm parallel, randomised superiority clinical trial was conducted in Australia and Denmark. Participants (18–40 years) were included who reported an insidious onset of knee pain (≥6 weeks duration); ≥3/10 numerical pain rating, that was aggravated by activities (eg, stairs, squatting, running). Participants were stratified by midfoot width mobility (high ≥11 mm change in midfoot width) and site, randomised to foot orthoses or hip exercises and blinded to objectives and stratification. Success was defined a priori as much better or better on a patient-perceived 7-point scale at 12 weeks.ResultsOf 218 stratified and randomised participants, 192 completed 12-week follow-up. This study found no difference in success rates between foot orthoses versus hip exercises in those with high (6/21 vs 9/20; 29% vs 45%, respectively) or low (42/79 vs 37/72; 53% vs 51%) midfoot width mobility. There was no association between midfoot width mobility and treatment outcome (Interaction effect p=0.19). This study found no difference in success rate between foot orthoses versus hip exercises (48/100 vs 46/92; 48% vs 50%).ConclusionMidfoot width mobility should not be used to help clinicians decide which patient with patellofemoral pain might benefit most from foot orthoses. Clinicians and patients may consider either foot orthoses or hip exercises in managing patellofemoral pain.Trial registration numberACTRN12614000260628.

Recurrence rates for ankle sprains are high. Therefore, preventive measures such as ankle bracing during sports are recommended.   To systematically evaluate the perceived ease of use, quality, comfort, stability, and hindrance of and the overall satisfaction with 3 contemporary brace types in 3 types of sports.   Randomized comparative user survey.   Recreational sports: soccer, volleyball, and running.   Young adult recreational athletes (29 soccer players, 26 volleyball players, and 31 runners).   Compression brace (CB), lace-up brace (LB), and semirigid brace (SB).   Rating of perceived ease of use, quality, comfort, stability, and hindrance of and overall satisfaction with the brace types during sports on a 5-point Likert scale. The secondary outcome measure was participants' willingness to buy the tested brace.   Overall, the 3 brace types received high mean scores for ease of use and quality. Soccer players preferred the CB over both alternatives, considering the higher scores for comfort (CB = 4.0, LB = 3.5, SB = 2.8), hindrance (CB = 3.7, LB = 2.9, SB = 2.8), overall satisfaction (CB = 3.6, LB = 3.0, SB = 2.5), and greatest willingness to buy this brace. Volleyball players preferred the LB over both alternatives, considering the higher scores for stability (LB = 4.2, CB = 3.2, SB = 3.3), overall satisfaction (LB = 3.8, CB = 3.0, SB = 3.0), and greatest willingness to buy this brace. Runners preferred the CB over both alternatives considering the better score for hindrance (CB = 3.6, LB = 2.8, SB = 2.9) and greatest willingness to buy this brace.   All 3 ankle-brace types scored high on perceived ease of use and quality. Regarding the brace types, soccer players, volleyball players, and runners differed in their assessments of subjective evaluation of comfort, stability, hindrance, overall satisfaction, and willingness to buy the brace. Soccer players and runners preferred the CB, whereas volleyball players preferred the LB.

Ankle foot orthoses (AFOs) are designed to improve gait for individuals with neuromuscular conditions and have also been used to reduce energy costs of walking for unimpaired individuals. AFOs influence joint motion and metabolic cost, but how they impact muscle function remains unclear. This study investigated the impact of different stiffness AFOs on medial gastrocnemius muscle (MG) and Achilles tendon (AT) function during two walking speeds. We performed gait analyses for eight unimpaired individuals. Each individual walked at slow and very slow speeds with a 3D printed AFO with no resistance (free hinge condition) and four levels of ankle dorsiflexion stiffness: 0.25Nm/°, 1Nm/°, 2Nm/°, and 3.7Nm/°. Motion capture, ultrasound, and musculoskeletal modeling were used to quantify MG and AT lengths with each AFO condition. Increasing AFO stiffness increased peak AFO dorsiflexion moment with decreased peak knee extension and peak ankle dorsiflexion angles. Overall musculotendon length and peak AT length decreased, while peak MG length increased with increasing AFO stiffness. Peak MG activity, length, and velocity significantly decreased with slower walking speed. This study provides experimental evidence of the impact of AFO stiffness and walking speed on joint kinematics and musculotendon function. These methods can provide insight to improve AFO designs and optimize musculotendon function for rehabilitation, performance, or other goals.

Background Foot orthoses produced using computer-aided-design and manufacture (CAD/CAM) are commonly used to treat musculoskeletal conditions of the foot and ankle, however minimal evidence exists as to the most effective method used to capture the patients foot shape. This trial aimed to determine the effectiveness and cost of insoles manufactured from a direct scan of the foot compared with those manufactured from foam-box casts. Methods This double blinded clinical trial randomly assigned participants with lower limb musculoskeletal pathologies into two groups and provided them with custom CAD/CAM foot orthoses manufactured either from a direct scan of the participants' feet (direct scan group) or from foam-box casts of their feet (foam-box cast group). 114 participants were recruited and asked to wear their foot orthoses for 12-weeks. The Foot Health Status Questionnaire (FHSQ) was completed at baseline, 4, 8 and 12-weeks to evaluate the primary outcome measure of pain, as well as secondary outcomes for foot function, foot health and footwear, and the Orthotic and Prosthetic User Survey Client Satisfaction with Device module (OPUS-CSD) was completed at 12-weeks. Adherence was measured using a daily wear-diary recorded over 12-weeks. The number of manual insole adaptations was also recorded, and staff time, material and transportation costs were evaluated. Results 112 participants completed the trial. Despite no significant between-group differences, both groups reported significant improvements in pain, function and foot health from baseline to 4, 8 and 12-weeks, which all exceeded their respective minimum important differences. The direct scan group reported greater satisfaction at 12-weeks ( p  = 0.04), greater adherence ( p  < 0.001), and required less insole adaptations ( n  = 4) compared to the foam-box cast group ( n  = 15) ( p  = 0.006). Overall costs and staff time costs were higher in the foam-box cast group. Conclusions CAD/CAM insoles are effective in reducing pain, and improving foot function and foot health after 4-weeks, and sustained at 12-weeks, however the method of shape capture does not affect these responses. Over 12-weeks participant satisfaction and adherence was greater when using the direct scan approach, which also required fewer manual insole adaptations. There was a greater overall cost associated with foam-box insoles. Clinicians are therefore recommended to use direct foot scanning over foam-box casting when prescribing CAD/CAM insoles for patients with musculoskeletal foot and ankle conditions. Trial registration ClinicalTrials.gov, trial number NCT05444192. Trial registration date 30th June 2022.

Progressive collapsing foot deformity (PCFD) is a debilitating condition causing significant biomechanical impairments. Custom-made foot orthoses (FOs) provide a non-invasive treatment by supporting the medial longitudinal arch and improving foot and ankle biomechanics. While previous studies on PCFD have predominantly investigated the biomechanical effects of FOs during walking, their impact on more demanding dynamic tasks remains unclear. This study aimed to investigate the effects of custom-made FOs on lower limb kinematics and kinetics during step-up (SU), step-down (SD), and step-down on a medially inclined surface (SDI) in individuals with PCFD. Twenty participants with flexible PCFD performed SU, SD and SDI tasks with and without FOs. Hip, knee, ankle and midfoot angles and moments were calculated and compared across conditions using one-dimensional statistical parametric mapping. Custom-made FOs reduced midfoot dorsiflexion across all tasks (SU: 4.9°; SD: 4.6°; SDI: 5.4°) and decreased ankle eversion during SU (2.9°) and SD (3.5°), but the reduction during SDI was non-significant. Custom FOs also reduced ankle inversion moments while increasing knee abduction moments during all step tasks. These findings indicate that custom-made FOs effectively support the medial longitudinal arch and limit foot pronation during dynamic movements, likely reducing loading on the medial ankle structures. However, their biomechanical efficacy was less pronounced when individuals with PCFD landed on a medially inclined surface. These findings highlight FOs potential as a conservative intervention for flexible PCFD to improve lower limb biomechanics.