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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.

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.

BackgroundLateral ankle sprains are common in indoor sports. High shoe–surface friction is considered a risk factor for non-contact lateral ankle sprains. Spraino is a novel low-friction patch that can be attached to the outside of sports shoes to minimise friction at the lateral edge, which could mitigate the risk of such injury. We aimed to determine preliminary effectiveness (incidence rate and severity) and safety (harms) of Spraino to prevent lateral ankle sprains among indoor sport athletes.MethodsIn this exploratory, parallel-group, two-arm pilot randomised controlled trial, 510 subelite indoor sport athletes with a previous lateral ankle sprain were randomly allocated (1:1) to Spraino or ‘do-as-usual’. Allocation was concealed and the trial was outcome assessor blinded. Match and training exposure, number of injuries and associated time loss were captured weekly via text messages. Information on harms, fear-of-injury and ankle pain was also documented.Results480 participants completed the trial. They reported a total of 151 lateral ankle sprains, of which 96 were categorised as non-contact, and 50 as severe. All outcomes favoured Spraino with incidence rate ratios of 0.87 (95% CI 0.62 to 1.23) for all lateral ankle sprains; 0.64 (95% CI 0.42 to 0.98) for non-contact lateral ankle sprains; and 0.47 (95% CI 0.25 to 0.88) for severe lateral ankle sprains. Time loss per injury was also lower in the Spraino group (1.8 vs 2.8 weeks, p=0.014). Six participants reported minor harms because of Spraino.ConclusionCompared with usual care, athletes allocated to Spraino had a lower risk of lateral ankle sprains and less time loss, with only few reported minor harms.Trial registration number NCT03311490.

Background Patellofemoral pain (PFP) is a common cause of knee pain in adolescents, but there are limited evidence-based treatment options for this population. Foot orthoses can improve pain and function in adults with PFP, and may be effective for adolescents. The primary aim of this study is to determine the feasibility of conducting a full-scale randomised controlled trial (RCT) evaluating the effects of contoured foot orthoses on knee pain severity and patient-perceived global change, compared to flat shoe insoles, in adolescents with PFP. The secondary aim is to provide an estimate of treatment effects for foot orthoses, compared to flat insoles, in adolescents with PFP. Methods This randomised, controlled, participant- and assessor-blinded, feasibility trial has two parallel groups. Forty adolescents (aged 12–18 years) with clinical symptoms of PFP will be recruited from Queensland, Australia. Participants will be randomised to receive either prefabricated contoured foot orthoses or flat shoe insoles. Both interventions will be fit by a physiotherapist, and worn for 3 months. Feasibility will be evaluated through assessing willingness of volunteers to enrol, number of eligible participants, recruitment rate, adherence with the study protocol, adverse effects, success of blinding, and drop-out rate. Secondary outcomes will evaluate knee-related pain, symptoms, function, quality of life, global rating of change, patient acceptable symptom state, and use of co-interventions, at 6 weeks and 3 months. Primary outcomes will be reported descriptively, while estimates of standard deviation and between-group differences (with 95% confidence intervals) will be reported for secondary outcomes. Discussion Findings of this study will inform the feasibility of a full-scale RCT investigating the efficacy of contoured foot orthoses in adolescents with PFP. This full-scale study is necessary to improve the evidence base for management of adolescent PFP, and enhance outcomes for this population. Trial registration ACTRN12619000957190 .

Background Foot and ankle characteristics are associated with patellofemoral pain (PFP) and may also relate to patellofemoral osteoarthritis (PFOA). A greater understanding of these characteristics and PFOA, could help to identify effective targeted treatments. Objectives To determine whether foot and ankle characteristics are associated with knee symptoms and function in individuals with PFOA. Methods For this cross-sectional study we measured weightbearing ankle dorsiflexion range of motion, foot posture (via the Foot Posture Index [FPI]), and midfoot mobility (via the Foot Measurement Platform), and obtained patient-reported outcomes for knee symptoms and function (100 mm visual analogue scales, Anterior Knee Pain Scale [AKPS], Knee injury and Osteoarthritis Outcome Score, repeated single step-ups and double-leg sit-to-stand to knee pain onset). Pearson’s r with significance set at p  < 0.05 was used to determine the association between foot and ankle charateristics, with knee symptoms and function, adjusting for age. Results 188 participants (126 [67%] women, mean [SD] age of 59.9 [7.1] years, BMI 29.3 [5.6] kg/m 2 ) with symptomatic PFOA were included in this study. Lower weightbearing ankle dorsiflexion range of motion had a small significant association with higher average knee pain (partial r = − 0.272, p  < 0.001) and maximum knee pain during stair ambulation (partial r = − 0.164, p  = 0.028), and lower scores on the AKPS (indicative of greater disability; partial r = 0.151, p  = 0.042). Higher FPI scores (indicating a more pronated foot posture) and greater midfoot mobility (foot mobility magnitude) were significantly associated with fewer repeated single step-ups (partial r = − 0.181, p  = 0.023 and partial r = − 0.197, p  = 0.009, respectively) and double-leg sit-to-stands (partial r = − 0.202, p  = 0.022 and partial r = − 0.169, p  = 0.045, respectively) to knee pain onset, although the magnitude of these relationships was small. The amount of variance in knee pain and disability explained by the foot and ankle characteristics was small (R 2 -squared 2 to 8%). Conclusions Lower weightbearing ankle dorsiflexion range of motion, a more pronated foot posture, and greater midfoot mobility demonstrated small associations with worse knee pain and greater disability in individuals with PFOA. Given the small magnitude of these relationships, it is unlikely that interventions aimed solely at addressing foot and ankle mobility will have substantial effects on knee symptoms and function in this population. Trial registration The RCT was prospectively registered on 15 March 2017 with the Australia and New Zealand Clinical Trials Registry ( ANZCTRN12617000385347 ).

To investigate the effects of custom-made foot orthoses on the torque- and power-cadence relationships and perceived comfort during maximal cycling exercises in a population of competitive road cyclists. Randomised, repeated measures, participant-blinded controlled study. Twenty-four competitive road cyclists (22 males, 2 females; aged 18–53 years) with mobile feet performed the torque–velocity test with custom-made and sham foot orthoses. For both conditions, the maximal power, optimal cadence, optimal torque, maximal torque, and maximal cadence were extracted from the individual torque- and power-cadence relationships. Comfort was assessed on a 150mm visual analogue scale. Paired-samples t-tests were used for comparison of means between conditions. No differences were observed between the custom-made and sham foot orthoses for any of the key variables extracted: maximal power (1022±180 vs. 1020±172W; p=0.794), optimal cadence (118±10 vs. 119±9rpm; p=0.682), optimal torque (82±10 vs. 82±11Nm; p=0.559), maximal torque (157±23 vs. 159±20 Nm; p=0.665) and maximal cadence (220±22 vs. 221±20rpm; p=0.935). There was no difference in comfort between custom-made and sham foot orthoses (106±30.5 vs. 116±25.0mm; p=0.995). Compared to the sham foot orthoses, the custom-made foot orthoses did not significantly affect the torque and power generating capacities or comfort during a maximal exercise performed on a stationary cycle ergometer.

Background Prefabricated foot orthoses are used to treat chronic nonspecific low back pain, however their effectiveness and potential mechanism of action is unclear. The primary aims of the study are to investigate the effectiveness of prefabricated foot orthotic devices for reducing pain and improving function in people with chronic nonspecific low back pain over 52 weeks. Methods This study is a participant and assessor blinded, parallel-group, superiority randomised (1:1) controlled trial. The study will recruit 60 participants aged 18 to 65 years with chronic nonspecific low back pain. Participants will undergo randomisation to a control group (The Back Book) or an intervention group (prefabricated foot orthoses and The Back Book). The primary outcome measures will be change in pain and function from baseline to 12 (primary time point), 26, and 52 weeks. Secondary outcome measures include: gluteus medius muscle activity and transversus abdominis muscle thickness from baseline to 12 weeks, physical activity over 12, 26, and 52 weeks, and correlation between foot type and change in measures of pain and function. Number of hours per day and week that the prefabricated orthoses are worn, as well as, adverse events will be self-reported by participants. Data will be analysed using the intention-to-treat principle. Discussion This trial will primarily evaluate the effectiveness of prefabricated foot orthotic devices for reducing pain and improving function in people with chronic nonspecific low back pain over 52 weeks. It is expected that this study will provide clinicians and researchers with an understanding of the role that prefabricated foot orthoses may have in the treatment of chronic nonspecific low back pain and a potential mechanism of action, and whether foot type influences the outcome. Trial registration ACTRN12618001298202 .

This systematic review evaluated the literature pertaining to the effect of shoes on lower limb venous status in asymptomatic populations during gait or exercise. The review was conducted in accordance with PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. The PubMed-NCBI, EBSCO Host, Cochrane Library and Science Direct databases were searched (March 2019) for words around two concepts: shoes and venous parameters. The inclusion criteria were as follows: (1) the manuscript had to be published in an English-language peer-reviewed journal and the study had to be observational or experimental and (2) the study had to suggest the analysis of many types of shoes or orthotics on venous parameters before, during and/or after exercise. Out of 366 articles, 60 duplications were identified, 306 articles were analyzed, and 13 articles met the eligibility criteria after screening and were included. This review including approximately 211 participants. The methodological rigor of these studies was evaluated with the modified Downs and Black quality index. Nine studies investigated the effect of shoes on blood flow parameters, two on venous pressure and two on lower limb circumferences with exercise. Evidence was found that unstable shoes or shoes with similar technology, sandals, athletic or soft shoes, and customized foot orthotics elicited more improvement in venous variables than high-heeled shoes, firm shoes, ankle joint immobilization and barefoot condition. These venous changes are probably related to the efficiency of muscle pumps in the lower limbs, which in turn seem to be dependent on shoe features associated with changes in the kinetics, kinematics and muscle activity variables in lower limbs during gait and exercise.

Although orthotic modification using the inverted technique is available for the treatment of flatfoot, empirical evidence for the biomechanical effects of inverted-angle foot orthoses (FOs) is lacking. The aim of this study was to evaluate the effects of different FO inversion angles on plantar pressure during gait in children with flatfoot. Twenty-one children with flexible flatfeet (mean age 9.9 years) were enrolled in this study. The plantar pressures were measured for the rearfoot; medial and lateral midfoot; and medial, central, and lateral forefoot as participants walked on a treadmill while wearing shoes only and shoes with the following 3 orthotic conditions: (i) orthosis with no inverted angle, (ii) orthosis with a 15° inverted angle, and (iii) orthosis with a 30° inverted angle. A one-way repeated measures analysis of variance (ANOVA) with the Bonferroni-adjusted post-hoc test was used to compare the mean values of each orthotic condition. Compared with the shoe only condition, the peak pressure decreased significantly under the medial forefoot and rearfoot with all FOs (p <0.05). However, no significant differences in the peak pressure under the medial forefoot and rearfoot were observed between the FOs. The peak pressure under the medial midfoot increased significantly with all FOs, and a maximal increase in the peak pressure was obtained with a 30° inverted angle orthosis. Furthermore, the contact area under the medial midfoot and rearfoot increased significantly with all FOs, compared with the shoe only condition (p <0.05). Again, no significant differences were observed between the FOs. For plantar pressure redistribution, a FO with a low inverted angle could be effective, accommodative, and convenient for children with flatfoot.

Background Foot orthoses are frequently used but little is known about which types are used in contemporary practice. This study aimed to explore the types of foot orthoses currently used by podiatrists and the prescription variations in a range of conditions. Methods A web-based, cross-sectional survey was distributed through professional bodies in the United Kingdom (UK), Australia, and New Zealand. Questions focussed on foot orthosis prescription habits in relation to 26 conditions affecting the back and lower limb. Results Two hundred and sixty-four podiatrists practising in 19 different countries completed the survey; the majority practised in the UK (47%, n  = 124), Australia (30%, n  = 79) and New Zealand (12%, n  = 32). Respondents qualified between 1968 and 2016, and 147 (56%) were female. Respondents worked in different healthcare sectors and this varied between countries: 42 (34%) respondents in the UK worked solely in the public sector, compared to 3 (4%) in Australia and 2 (6%) in New Zealand. Forty-four (35%) respondents in the UK worked solely in private practice, compared to 64 (81%) in Australia and 14 (44%) in New Zealand. UK respondents prescribed more prefabricated orthoses per week (mean 5.5 pairs) than simple insole-type devices (±2.7) and customised devices (±2.9). Similarly, respondents in New Zealand prescribed more prefabricated orthoses per week (±7.7) than simple (±1.4) and customised (±2.8) devices. In contrast, those in Australia prescribed more customised orthoses per week (±4.4) than simple (±0.8) and prefabricated (±1.9) orthoses. Differences in the types of orthoses prescribed were observed between country of practice, working sector, and the condition targeted. Generally, prefabricated orthoses were commonly prescribed for the 26 highlighted conditions in the UK and New Zealand. Australian podiatrists prescribed far fewer devices overall, but when they did prescribe, they were more likely to prescribe custom devices. Respondents in all three countries were more likely to prescribe customised orthoses for people with diabetes complicated by peripheral neuropathy than for diabetes without this complication. Conclusions Foot orthosis prescription habits vary between countries. Prefabricated orthoses were frequently prescribed in the UK and New Zealand, and customised orthoses in Australia. Prescriptions for people with diabetes differed depending on the presence of neuropathy, despite a lack of robust evidence supporting these decisions. This study provides new insight into contemporary practice.