Human-in-the-loop optimization of rocker shoe to reduce plantar pressure and collision work simultaneously.

BACKGROUND: Rocker shoes can be used to reduce foot pressure and adjust lower limb kinetics for various patient population, such as people with diabetic peripheral neuropathy. Selecting adequate properties of the rocker sole is of great importance for its efficacy. This study investigated the capability of human-in-the-loop optimization (HILO) to individually optimize apex position and angle of rocker shoe to reduce peak pressure and collision work simultaneously. METHODS: Peak pressure, kinetic, and kinematic data were recorded from 10 healthy participants while walking at preferred speed wearing rocker shoes with adjustable apex position and angle. An evolutionary algorithm was used to find optimal apex parameters to reduce both peak pressure in medial forefoot and collision work. The optimized shoe (HILO shoe) was compared with generic optimal rocker settings (Chapman settings) and normal shoe. FINDINGS: Compared to normal shoe, the HILO shoe had lower plantar pressure (pHILO = 0.007; pChapman = 0.044) and Chapman shoe showed higher collision work (pHILO = 0.025; pChapman = 0.014). Both HILO and Chapman shoe had smaller push-off work than normal shoe (pHILO = 0.001; pChapman < 0.001) with the Chapman shoe exhibited earlier push-off onset (pHILO = 0.257; pChapman = 0.016). INTERPRETATION: The Human-in-the-loop optimization approach resulted in individualized apex settings which performed on average similar to Chapman settings but, were superior in selected cases. In these cases, medial forefoot could be further offloaded with apex angles larger than generic settings. The larger apex angle might increase the external ankle moment arm and push-off work. However, there is limited room for improvement on collision work compared to generic settings.

Effects of individually optimized rocker midsoles and self-adjusting insoles on dynamic stability in persons with diabetes mellitus and neuropathy.

BACKGROUND: Persons with diabetic peripheral neuropathy (DPN) may face challenges such as balance issues due to reduced somatosensory feedback and an increased risk of developing diabetic foot ulcers (DFUs) due to increased plantar pressure. Pressure reducing footwear is thought to further impair balance. We introduced 3D-printed rocker midsoles and self-adjusting insoles that are able to reduce elevated plantar pressure values and aimed to prevent balance deterioration. However, their effect on the balance during walking (dynamic stability) is not analyzed yet. RESEARCH QUESTION: Is dynamic stability of persons with DPN impaired compared to healthy individuals and what is the effect of the 3D-printed rocker midsoles and self-adjusting insoles on the dynamic stability in this population? METHODS: Dynamic stability, specifically the margins of stability (MOS) in the anterior-posterior (AP) and medio-lateral (ML) direction, was measured in ten healthy and nineteen persons with DPN. Independent-samples t-test was applied to analyze the difference in the MOS between groups. One-way repeated measures analyses of variance (ANOVA) was conducted to test the difference between the therapeutic footwear combinations within the DPN group. RESULTS: There is no significant difference between the healthy and DPN group in MOS-AP. MOS-ML is significantly larger in DPN compared to the healthy participants. Using the self-adjusting insole shows a significantly lower (negative) MOS-AP compared to when using a rocker shoe within the DPN group. SIGNIFICANCE: This study provides valuable information on whether DPN and our therapeutic footwear have a negative effect on the dynamic stability. DPN does not have a negative effect on dynamic stability in the AP direction. For the ML direction, DPN seems to cause larger MOS-ML by likely using a compensation strategy (e.g., wider steps) while our experimental footwear does not further impair the MOS-ML.

Effects of individually optimized rocker midsoles and self-adjusting insoles on plantar pressure in persons with diabetes mellitus and loss of protective sensation.

INTRODUCTION: Rocker shoes and insoles reduce peak pressure (PP) in persons with diabetes (DM) and loss of protective sensation (LOPS). However, they are handmade, leading to inconsistent effectiveness. If foot structure changes over time, high PP-locations also change. To address this, individualized algorithm based 3D-printed rockers and self-adjusting pressure-reducing insoles are applied. METHODS: PP across seven foot regions was analyzed in 21 persons with DM and LOPS. Regions with PP < 200 kPa were considered not at risk (RnoR); regions with PP ≥ 200 kPa at risk (RaR). The aim was to offload RaR, while remaining PP < 200 kPa in RnoR. RESULTS: Individualized rockers and self-adjusting insoles combined successfully reduce PP < 200 kPa (on average 24 % - 48 %) in all feet with toes, central and lateral forefoot identified as RaR. Same intervention reduces PP in 68 % of the feet with medial forefoot identified as RaR. With the heel as RaR, no intervention reduces PP successfully in all feet. CONCLUSIONS: Individualized 3D-printed rockers combined with self-adjusting insoles reduce PP (< 200 kPa) in toes, central and lateral forefoot, but not in heels. Alternative insoles with medial arch support, heel cup and compliant midsole materials might enhance success rate across entire foot.

Standardized circuit class group training versus individualized goal-directed group training to improve upper limb function in stroke survivors during in-patient rehabilitation: a pragmatic trial.

PURPOSE: To investigate the usability and effectiveness of standardized circuit class group training (CCT) compared to individualized goal-directed group training (GDT) in subacute stroke survivors. MATERIALS AND METHODS: This study consists of three parts. Part 1 involved a pragmatic, non-randomized controlled trial with subacute participants and their therapists, who participated in four weeks either CCT or GDT. Superiority of the intervention was defined as significantly larger improvement on the Motor Activity Log for patients and lower workload for therapists. In Part 2, six additional workstations were developed for CCT. Part 3 replicated the study of Part 1 with the expanded CCT. RESULTS: Part 1 showed no difference in effectiveness between training methods. CCT did not match the rehabilitation goals of the patient sufficiently, however mental workload seemed lower for therapists. An expansion of CCT could improve the match between the patient's goals and the training (Part 2). Results of Part 3 showed again no difference in effectiveness between methods. CCT was however perceived as less engaging compared to GDT, but mental load for therapists remained lower. CONCLUSIONS: A standardized training could reduce the mental workload for therapists, but patients seemed less engaged. A combination of both might be most beneficial.Trial registration: Dutch Trial Register: NL8844 and NL9471IMPLICATIONS FOR REHABILITATIONProviding a standardized training program after stroke reduces therapists' mental workload.Individualized goal-directed group training results in the best achievement of rehabilitation goals.A combination of standardized and individual training would use best of both intervention modalities.Patients should be involved in the co-creation developing process of training programs.

Stroke survivors' experiences with home-based telerehabilitation using an assistive device to improve upper limb function: a qualitative study.

PURPOSE: Patients in the chronic phase after stroke often lack the possibility to intensively train their upper limb function. Assistive devices can be a solution to training intensively at home. This qualitative study investigated stroke survivors' experiences regarding training using the hoMEcare aRm rehabiLItatioN (MERLIN) system, an assistive device and telecare platform. We investigated patients' perspectives regarding the home-based training with the MERLIN system, on the International Classification of Functioning, Disability and Health (ICF) domains and the facilitators and barriers of the MERLIN system. METHODS: Eleven patients in the chronic phase of stroke who completed the MERLIN trial took part in semi-structured interviews. Interviews were analysed using the framework method. RESULTS: Participants were in general positive about the device and the training. Several experienced positive effects on ICF body functions, such as joint range of motion and self-confidence. Some experienced improvements in activities, but not on participation level. Home training had advantages: flexibility in training time and duration and no need to travel. The major barriers were technical hard- and software issues and ergonomic complaints. A list of recommendations regarding assistive devices and home-based rehabilitation was created. CONCLUSIONS: Homebased training using an assistive device was well received by stroke patients to train their upper limb function. Future device developers should take patients' feedback into account to overcome the barriers related to the introduction of new assistive devices at home. Our recommendations may be the first step to implementing patients' perspectives during the early stages of device development. Implications for rehabilitationTraining at home was a well-received and convenient solution to improve the upper limb functionBarriers regarding hard- and software and device ergonomics need to be addressed in future assistive devicesRecommendations are provided for more successful implementation of assistive devices and home-based telerehabilitation programs.

Effects of rocker radii with two longitudinal bending stiffnesses on plantar pressure distribution in the forefoot.

INTRODUCTION: Outsole parameters of the shoe can be adapted to offload regions of pain or region of high pressures. Previous studies already showed reduced plantar pressures in the forefoot due to a proximally placed apex position and higher longitudinal bending stiffness (LBS). The aim of this study was to determine the effect of changes in rocker radii and high LBS on the plantar pressure profile during gait. METHOD: 10 participants walked in seven shoe conditions of which one control shoe and six rocker shoes with small, medium and large rocker radii and low and high longitudinal bending stiffness. Pedar in-shoe plantar pressure measuring system was used to quantify plantar pressures while walking on a treadmill at self-selected walking speed. Peak plantar pressure, maximum mean pressure and force-time integral were analyzed with Generalized Estimated Equation (GEE) and Tukey post hoc correction (α = .05). RESULTS: Significantly lower plantar pressures were found in the first toe, toes 2-5, distal and proximal forefoot in all rocker shoe conditions as compared to the control shoe. Plantar pressures in the first toe and toes 2-5 were significantly lower in the small radius compared to medium and large radii. For the distal forefoot both small and medium radii significantly reduced plantar pressure compared to large radii. Low LBS reduced plantar pressure at the first toe significantly compared to high LBS independent of the rocker radius. Plantar pressures in the distal forefoot and toes 2-5 were lower in high LBS compared to low LBS. CONCLUSION: Manipulation of the rocker radius and LBS can effectively reduce peak plantar pressures in the forefoot region during gait. In line with previous studies, we showed that depending on the exact target location for offloading, different combinations of rocker radius and LBS need to be adopted to maximize treatment effects.

Effects of Longitudinal Bending Stiffness of forefoot rocker profile shoes on ankle kinematics and kinetics.

INTRODUCTION: Rocker profile shoes with a proximally placed apex are currently one of the most prescribed shoe modifications for treatment and prevention of lower leg deficits. Three geometrical rocker design parameters apex position (AP), apex angle (AA) and rocker radius (RR) influence both plantar pressure redistribution and kinetic and kinematic alterations of the lower leg. In addition, longitudinal bending stiffness (LBS) of the outsole influences these parameters as well. This study aims to investigate the effects of the LBS in combination with different forefoot radii of rocker shoes on kinematics and kinetics of the lower limb. METHODS: 10 participants walked in standard shoes and six experimental shoe conditions with high and low LBS and three different forefoot rocker radii with the same (proximal) AP and AA. Lower extremity kinematics and kinetics were collected while walking on an instrumented treadmill at preferred walking speed and analysed with a repeated measures ANOVA and Statistical Parametric Mapping (SPM) (α = .05; post hoc α = .05/6). RESULTS: SPM analyses revealed no significant differences for LBS and interaction LBS*RR for most research variables in terminal stance (ankle angle, ankle moment, ankle power, foot-to-horizontal angle, shank-to-vertical angle, external ankle moment, ground reaction force angle). A significant LBS effect was found for anterior-posterior position of the centre of pressure during pre-swing and peak ankle dorsiflexion angle. No relevant significant differences were found in spatio-temporal parameters and total work at the ankle between low and high LBS. CONCLUSION: This study showed that longitudinal bending stiffness does not affect the biomechanical working mechanism of rocker profile shoes as long as toe plantarflexion is restricted. Providing that the forefoot rocker radius supports at least a normal foot-to-horizontal angle at toe-off, there is no reason to increase sole stiffness to change ankle kinematics and kinetics.

The correlation between posterior tibial slope and dynamic anterior tibial translation and dynamic range of tibial rotation.

PURPOSE: The amount of passive anterior tibial translation (ATT) is known to be correlated to the amount of posterior tibial slope (PTS) in both anterior cruciate ligament-deficient and reconstructed knees. Slope-altering osteotomies are advised when graft failure after anterior cruciate ligament (ACL) reconstruction occurs in the presence of high PTS. This recommendation is based on studies neglecting the influence of muscle activation. On the other hand, if dynamic range of tibial rotation (rTR) is related to the amount of PTS, a "simple" anterior closing-wedge osteotomy might not be sufficient to control for tibial rotation. The purpose of this study was to evaluate the correlation between the amount of PTS and dynamic ATT and tibial rotation during high demanding activities, both before and after ACL reconstruction. We hypothesized that both ATT and rTR are strongly correlated to the amount of PTS. METHODS: Ten subjects were studied both within three months after ACL injury and one year after ACL reconstruction. Dynamic ATT and dynamic rTR were measured using a motion-capture system during level walking, during a single-leg hop for distance and during a side jump. Both medial and lateral PTS were measured on MRI. A difference between medial and lateral PTS was calculated and referred to as Δ PTS. Spearman's correlation coefficients were calculated for the correlation between medial PTS, lateral PTS and Δ PTS and ATT and between medial PTS, lateral PTS and Δ PTS and rTR. RESULTS: Little (if any) to weak correlations were found between medial, lateral and Δ PTS and dynamic ATT both before and after ACL reconstruction. On the other hand, a moderate-to-strong correlation was found between medial PTS, lateral PTS and Δ PTS and dynamic rTR one year after ACL reconstruction. CONCLUSION: During high-demand tasks, dynamic ATT is not correlated to PTS. A compensation mechanism may be responsible for the difference between passive and dynamic ATT in terms of the correlation to PTS. A moderate-to-strong correlation between amount of PTS and rTR indicates that such a compensation mechanism may fall short in correcting for rTR. These findings warrant prudence in the use of a pure anterior closing wedge osteotomy in ACL reconstruction. TRIAL REGISTRATION: Netherlands Trial Register, Trial 7686 . Registered 16 April 2016-Retrospectively registered. LEVEL OF EVIDENCE: Level 2, prospective cohort study.

Effect of different forefoot rocker radii on lower-limb joint biomechanics in healthy individuals.

INTRODUCTION: Previous studies showed that rocker shoes with a stiff forefoot rocker profile significantly reduce peak plantar flexion moment at the ankle (PFM) and peak ankle dorsiflexion (DF). Both parameters are related to Achilles tendon and Plantar Fascia unloading. The shape of an outsole with a forefoot rocker is described with multiple rocker design parameters. The aim of this research is, to determine the relation between different forefoot rocker radii on peak DF and peak PFM at a self-selected walking speed. METHODS: 10 participants walked in standard shoes and three experimental pairs of shoes with different forefoot rocker radii. Lower extremity kinematics and kinetics were collected while walking on an instrumented treadmill at preferred walking speed and analysed with Statistical Parametric Mapping (SPM) (α = .05; post-hoc α = .05/6). RESULTS: Peak value analyses showed significant decreases in peak DF, peak PFM, and peak ankle power generation for the rocker conditions. No relevant significant differences were found in spatio-temporal parameters and total work at the ankle joint. SPM showed a significant decrease (% gait cycle) in DF (40-69 %), PFM (7-15 %; 41-68 %; 69-81 %), ankle power (10-15 %; 32-51 %; 55-64 %; 64-67 %; 72-80 %) and foot-to-horizontal angle (FHA) (0-4 %; 40-62 %; 92-100 %) and an increased shank-to-vertical angle (SVA) (44-84 %) for the rocker conditions. CONCLUSION: The results of this study suggest that rocker shoes with a proximally placed apex significantly reduce DF and PFM during the third rocker compared with control shoes. This effect is mainly explained by a change in the FHA. Smaller radii cause the largest reductions in DF and PFM, so therefore, a uniform standardisation of the forefoot rocker radius is essential.

Gaze direction affects walking speed when using a self-paced treadmill with a virtual reality environment.

BACKGROUND: In a previous study it was observed that participants increase their walking speed during a dual task while walking on a self-paced treadmill in a virtual reality (VR) environment (Gait Real time Analysis Interactive Lab (GRAIL)). This observation is in contrast with the limited resources hypothesis, which suggests walking speed of healthy persons to decrease when performing a cognitive dual task. AIM: The aim of the present study was therefore to determine whether the cognitive demand of the task, an aroused feeling, discrepancy in optic flow or a change in gaze direction caused participants to walk faster in this computer assisted rehabilitation environment. MATERIALS: The GRAIL included a self-paced treadmill, a motion-capture system and synchronized VR environments. METHODS: Thirteen healthy young adults (mean age 21.6 ±â€¯2.5) were included in this study. Participants walked on the self-paced treadmill while seven different intervention conditions (IC) were offered. Prior to each IC, a control condition (CC) was used to determine the natural self-selected walking speed. Walking speed during the last 30 s of each IC was compared with the walking speed during the last 30 s of the preceding CC. RESULTS: Results show that the height on which a visual task was presented in the VR environment, influenced walking speed. Participants walked faster when gaze was directed above the focus of expansion. SIGNIFICANCE: These findings contribute to a further understanding of the differences between walking in a real life environment or computer assisted rehabilitation environment. When analyzing gait on a self-paced treadmill in the future, one must be attentive where to place a visual stimulus in the VR environment.

Effects of interventions on normalizing step width during self-paced dual-belt treadmill walking with virtual reality, a randomised controlled trial.

BACKGROUND: Step width is increased during dual-belt treadmill walking, in self-paced mode with virtual reality. Generally a familiarization period is thought to be necessary to normalize step width. AIM: The aim of this randomised study was to analyze the effects of two interventions on step width, to reduce the familiarization period. METHODS: We used the GRAIL (Gait Real-time Analysis Interactive Lab), a dual-belt treadmill with virtual reality in the self-paced mode. Thirty healthy young adults were randomly allocated to three groups and asked to walk at their preferred speed for 5min. In the first session, the control-group received no intervention, the 'walk-on-the-line'-group was instructed to walk on a line, projected on the between-belt gap of the treadmill and the feedback-group received feedback about their current step width and were asked to reduce it. Interventions started after 1min and lasted 1min. During the second session, 7-10days later, no interventions were given. FINDINGS: Linear mixed modeling showed that interventions did not have an effect on step width after the intervention period in session 1. Initial step width (second 30s) of session 1 was larger than initial step width of session 2. Step width normalized after 2min and variation in step width stabilized after 1min. INTERPRETATION: Interventions do not reduce step width after intervention period. A 2-min familiarization period is sufficient to normalize and stabilize step width, in healthy young adults, regardless of interventions. A standardized intervention to normalize step width is not necessary.

Early Post-operative Mortality After Major Lower Limb Amputation: A Systematic Review of Population and Regional Based Studies.

OBJECTIVE: Lower limb amputation is often associated with a high risk of early post-operative mortality. Mortality rates are also increasingly being put forward as a possible benchmark for surgical performance. The primary aim of this systematic review is to investigate early post-operative mortality following a major lower limb amputation in population/regional based studies, and reported factors that might influence these mortality outcomes. METHODS: Embase, PubMed, Cinahl and Psycinfo were searched for publications in any language on 30 day or in hospital mortality after major lower limb amputation in population/regional based studies. PRISMA guidelines were followed. A self developed checklist was used to assess quality and susceptibility to bias. Summary data were extracted for the percentage of the population who died; pooling of quantitative results was not possible because of methodological differences between studies. RESULTS: Of the 9,082 publications identified, results were included from 21. The percentage of the population undergoing amputation who died within 30 days ranged from 7% to 22%, the in hospital equivalent was 4-20%. Transfemoral amputation and older age were found to have a higher proportion of early post-operative mortality, compared with transtibial and younger age, respectively. Other patient factors or surgical treatment choices related to increased early post-operative mortality varied between studies. CONCLUSIONS: Early post-operative mortality rates vary from 4% to 22%. There are very limited data presented for patient related factors (age, comorbidities) that influence mortality. Even less is known about factors related to surgical treatment choices, being limited to amputation level. More information is needed to allow comparison across studies or for any benchmarking of acceptable mortality rates. Agreement is needed on key factors to be reported.

Prospective Study of the Relation between Landing Biomechanics and Jumper's Knee.

The literature on the relation between jump biomechanics and jumper's knee indicates that a jump with horizontal displacement poses a threat for developing jumper's knee. Subjects with jumper's knee have been shown to display a stiff landing pattern characterized by a small range of motion. However, up to now only cross-sectional studies have been conducted. 6 teams from sports involving repetitive landing were followed prospectively for 2 years. At baseline athletes performed the Landing Error Scoring System jump and 3D kinematics and kinetics were obtained. A comparison was made between subjects who developed jumper's knee and those who did not develop it. 3 subjects developed jumper's knee during the study. Leg stiffness during landing was high compared to the mean of the healthy controls. No common kinematic patterns could be identified in these 3 subjects. The results suggest that athletes with high leg stiffness during landing might have an increased risk for developing jumper's knee, yet this conclusion is based on a very small sample. Subjects who develop jumper's knee do not show a common landing technique. Further research is needed to investigate whether leg stiffness can be used to identify athletes at risk and as a target variable to be used in prevention.

Running with a minimalist shoe increases plantar pressure in the forefoot region of healthy female runners.

OBJECTIVES: Minimalist running shoes have been proposed as an alternative to barefoot running. However, several studies have reported cases of forefoot stress fractures after switching from standard to minimalist shoes. Therefore, the aim of the current study was to investigate the differences in plantar pressure in the forefoot region between running with a minimalist shoe and running with a standard shoe in healthy female runners during overground running. DESIGN: Randomized crossover design. METHODS: In-shoe plantar pressure measurements were recorded from eighteen healthy female runners. Peak pressure, maximum mean pressure, pressure time integral and instant of peak pressure were assessed for seven foot areas. Force time integral, stride time, stance time, swing time, shoe comfort and landing type were assessed for both shoe types. A linear mixed model was used to analyze the data. RESULTS: Peak pressure and maximum mean pressure were higher in the medial forefoot (respectively 13.5% and 7.46%), central forefoot (respectively 37.5% and 29.2%) and lateral forefoot (respectively 37.9% and 20.4%) for the minimalist shoe condition. Stance time was reduced with 3.81%. No relevant differences in shoe comfort or landing strategy were found. CONCLUSIONS: Running with a minimalist shoe increased plantar pressure without a change in landing pattern. This increased pressure in the forefoot region might play a role in the occurrence of metatarsal stress fractures in runners who switched to minimalist shoes and warrants a cautious approach to transitioning to minimalist shoe use.

Development of clinical guidelines for the prescription of orthoses in patients with neurological disorders in The Netherlands.

The objective of this study was to develop guidelines for the prescription of ankle-foot, knee, wrist-hand and elbow orthoses for patients with neurological disorders. The study is part of a more comprehensive study focusing on the development of clinical guidelines for the prescription of these orthoses in a wider patient population. Evidence from literature (reviews, randomized controlled trials with good quality), information from literature with a lower degree of evidence and information from structured interviews with experts in the field of orthotics, form the basis of statements presented in a Delphi procedure. The Delphi technique was used to gain consensus on statements published on the Internet. A group of experts in the field of orthotics and neurological disorders was asked to give their opinion on 41 statements. Statements with a general agreement of at least 75% were accepted. Statements with less general agreement were rewritten and the experts could react in a second and possibly in a third round. Afterwards, an opinion-based workshop was organized in which participants could react on preliminary guidelines and on Delphi-statements with between 65% and 75% agreement. Consensus on 32 statements was gained during the three rounds and the opinion-based workshop. These statements form the basis of the consensus based clinical guidelines for the prescription of orthoses in patients with neurological disorders.

Elbow orthoses: a review of literature.

The objective of this study is to review the available literature on elbow orthoses in patients with various diagnoses to assess the scientific base of the prescription of elbow orthoses. A search of literature in Medline, Embase, Cochrane and Recal was performed using the keyword "elbow" combined with "orthosis related keywords". Abstracts were read to select the papers dealing primarily with monoarticular elbow orthoses. References of the selected papers were also examined. A total of 57 papers were read of which 18 met the selection criteria. Both the quality and quantity of the studies appeared to be low, so in this study no definitive conctusions can be drawn about the efficacy of monoarticular elbow orthoses. Current prescriptions of elbow orthoses cannot be evidence based, because no scientific evidence on elbow orthoses is available.