Incorporating an exercise rehabilitation programme for people with intermittent claudication into an established cardiac rehabilitation service: A protocol for a pilot study.

INTRODUCTION: Current UK guidance for the treatment of intermittent claudication (IC) states that supervised exercise programmes (SEPs) should be offered as first-line treatment [1], prior to surgical interventions. However, there is currently a national shortage of dedicated SEPs. It has been suggested that the established network of UK Cardiac Rehabilitation (CR) programmes could cater for IC patients. This study will investigate the feasibility of combining IC and CR patients into one SEP, and explore the patient perception's regarding the treatment programme, to establish whether CR could potentially fill the gap in service provision. METHODS AND ANALYSIS: Patients diagnosed with IC will be incorporated into a CR programme where they will exercise alongside patients with coronary artery disease (CAD). Participants will attend a 2-h class, once a week for a total of 12 weeks. Another group of IC patients will attend an SEP consisting solely of other IC patients (control group). OUTCOME MEASURES: The study will evaluate the feasibility of recruitment, retention, and participant experience of the intervention as well as physiological outcomes (primary outcome: pain-free walking, and maximal walking distance; secondary outcomes: physical activity levels, perceived walking ability, and disease-specific quality of life). Outcomes will be assessed at baseline and on completion of the SEP. ETHICS AND DISSEMINATION: Ethical approval for this study was obtained from North West- Greater Manchester West Research Ethics Committee on 13th June 2018 (IRAS ID: 230391). This study is registered with clinicaltrials. gov (NCT03564080) and conforms to the Declaration of Helsinki. Results will be disseminated via national conferences and published in peer-reviewed journals.

Quantifying sit-to-stand and stand-to-sit transitions in free-living environments using the activPAL thigh-worn activity monitor.

PURPOSE: Standing up, sitting down and walking require considerable effort and coordination, which are crucial indicators to rehabilitation (e.g. stroke), and in older populations may indicate the onset of frailty and physical and cognitive decline. Currently, there are few reports robustly quantifying sit-to-stand and stand-to-sit transitions in free-living environments. The aim of this study was to identify and quantify these transitions using the peak velocity of sit-to-stand and stand-to-sit transitions to determine if these velocities were different in a healthy cohort and a mobility-impaired population. METHODS: Free-living sit-to-stand and stand-to-sit acceleration data were recorded from 21 healthy volunteers and 34 stroke survivors using activPAL3™ monitors over a one-week period. Thigh inclination velocity was calculated from these accelerometer data. Maximum velocities were compared between populations. RESULTS: A total of 10,299 and 11,392 sit-to-stand and stand-to-sit transitions were recorded in healthy volunteers and stroke survivors, respectively. Healthy volunteers had significantly higher overall mean peak velocities for both transitions compared with stroke survivors [70.7°/s ± 52.2 versus 44.2°/s ± 28.0 for sit-to-stand, P < 0.001 and 74.7°/s ± 51.8 versus 46.0°/s ± 31.9 for stand-to-sit; P < 0.001]. Mean peak velocity of transition was associated with increased variation in peak velocity across both groups. CONCLUSION: There were significant differences in the mean peak velocity of sit-to-stand and stand-to-sit transitions between the groups. Variation in an individual's mean peak velocity may be associated with the ability to perform these transitions. This method could be used to evaluate the effectiveness of interventions following injury such as stroke, as well as monitor decline in functional ability.

Evaluating the effect of a haemoglobin spray on size reduction in chronic DFUs.

AIM: The aim of this multi-centre observational evaluation was to assess the percentage reduction in wound area of non-healing diabetic foot ulcers (DFUs), treated with Granulox haemoglobin spray over a 4-week period. Secondary outcome parameters--for example, adverse events, patient acceptability and ease of use--were also recorded. METHOD: After a run-in-period (2 weeks for existing patients and 4 weeks for new patients) to determine if the wounds were non-healing despite receiving local best practice, patients whose foot ulcers had decreased in size by < 20% were then entered into the evaluation. A sample of 17 patients (4 females and 13 males), comprising 4 with type 1 and 13 with type 2 diabetes, with a total of 20 DFUs, met the inclusion criteria. These data were collected from six sites across the UK. RESULTS: There was an overall positive reduction in size in 15 of the wounds, equating to a mean reduction of 53.8% (standard deviation (SD): 26.6; range: 11.9-100%). One participant, with two ulcers, had to be withdrawn due to infection. All clinicians and participants found the product easy to use. CONCLUSION: The addition of a topical oxygenation therapy in this cohort of non-healing DFUs showed reduction in wound surface area and progression to healing. The product was also found to be acceptable and very easy to use by both participants and clinicians.

Does flip-flop style footwear modify ankle biomechanics and foot loading patterns?

BACKGROUND: Flip-flops are an item of footwear, which are rubber and loosely secured across the dorsal fore-foot. These are popular in warm climates; however are widely criticised for being detrimental to foot health and potentially modifying walking gait. Contemporary alternatives exist including FitFlop, which has a wider strap positioned closer to the ankle and a thicker, ergonomic, multi-density midsole. Therefore the current study investigated gait modifications when wearing flip-flop style footwear compared to barefoot walking. Additionally walking in a flip-flop was compared to that FitFlop alternative. METHODS: Testing was undertaken on 40 participants (20 male and 20 female, mean ± 1 SD age 35.2 ± 10.2 years, B.M.I 24.8 ± 4.7 kg.m(-2)). Kinematic, kinetic and electromyographic gait parameters were collected while participants walked through a 3D capture volume over a force plate with the lower limbs defined using retro-reflective markers. Ankle angle in swing, frontal plane motion in stance and force loading rates at initial contact were compared. Statistical analysis utilised ANOVA to compare differences between experimental conditions. RESULTS: The flip-flop footwear conditions altered gait parameters when compared to barefoot. Maximum ankle dorsiflexion in swing was greater in the flip-flop (7.6 ± 2.6°, p = 0.004) and FitFlop (8.5 ± 3.4°, p < 0.001) than barefoot (6.7 ± 2.6°). Significantly higher tibialis anterior activation was measured in terminal swing in FitFlop (32.6%, p < 0.001) and flip-flop (31.2%, p < 0.001) compared to barefoot. A faster heel velocity toward the floor was evident in the FitFlop (-.326 ± .068 m.s(-1), p < 0.001) and flip-flop (-.342 ± .074 m.s(-1), p < 0.001) compared to barefoot (-.170 ± .065 m.s(-1)). The FitFlop reduced frontal plane ankle peak eversion during stance (-3.5 ± 2.2°) compared to walking in the flip-flop (-4.4 ± 1.9°, p = 0.008) and barefoot (-4.3 ± 2.1°, p = 0.032). The FitFlop more effectively attenuated impact compared to the flip-flop, reducing the maximal instantaneous loading rate by 19% (p < 0.001). CONCLUSIONS: Modifications to the sagittal plane ankle angle, frontal plane motion and characteristics of initial contact observed in barefoot walking occur in flip-flop footwear. The FitFlop may reduce risks traditionally associated with flip-flop footwear by reducing loading rate at heel strike and frontal plane motion at the ankle during stance.

A cross-sectional study of age-related changes in plantar pressure distribution between 4 and 7 years: a comparison of regional and pixel-level analyses.

Quantifying morphological and functional development in children's feet, and thereby establishing development norms is difficult. In addition to practical challenges of experimentation on children, measurement equipment like plantar pressure (PP) platforms are almost exclusively geared towards adult-sized feet. These PP quantification problems may be exacerbated by typical regional data analysis techniques, which further reduce spatial resolution. The goal of this study was to quantify PP distributions in developing children, and also to compare the results obtained from typical (regional) techniques with those obtained from a higher-resolution (pixel-level) technique. Ninety-eight children between four and seven years of age were assessed in a cross-sectional design. Maximum PP distributions were collected for each child, and these pressures were linearly regressed against age. Present results agree with previous investigations in that maximum pressures and maximum pressure changes occurred in the forefoot. However, results from the present pixel-level technique suggest that these changes are limited to the central metatarsals, and that regional methods can suggest significance where none exists in the actual raw (pixel-level) data, due to signal aliasing and, in particular, to conflation of regional boundaries. We postulate that increased central metatarsal pressures are reflective of the coupling between generalised joint laxity decreases and relatively increasingly inclined central metatarsal bones with age.

The biomechanical effects of a new design of lateral wedge insole on the knee and ankle during walking.

Lateral wedged insoles are a common treatment in individuals with medial tibiofemoral osteoarthritis of the knee joint. One concern has been the potential for increased foot and ankle pain due to increased eversion. The purpose of this study was to assess the biomechanical effectiveness of a typical lateral wedged insole and a combined insole with a lateral wedge and off-the-shelf anti-pronatory device in shoes while walking. A cross-over randomized design was used where each insole was worn by fifteen healthy subjects while three-dimensional motion data were collected in three different conditions: (1) control condition (with standard shoes), (2) with an insole with a lateral wedge and additional off-the-shelf anti-pronatory support (supporting), and (3) with an insole with a lateral wedge with no additional support (unsupported) in the standard shoes. The unsupported insole significantly increased the amount of ankle/subtalar joint complex eversion than the other experimental conditions, with the supporting insole reducing the ankle/subtalar joint complex eversion, and was found to be more comfortable. Both the supporting and unsupported lateral wedged insoles significantly reduced knee loading (external knee adduction moment reduction 8.5% and 9.1%, respectively), the knee adduction angular impulse. This new design of lateral wedge may offer increased adherence in future osteoarthritis population studies while offering reductions in joint loading.

A new approach to prevention of knee osteoarthritis: reducing medial load in the contralateral knee.

OBJECTIVE: Few if any prevention strategies are available for knee osteoarthritis (OA). In those with symptomatic medial OA, the contralateral knee may be at high risk of disease, and a reduction in medial loading in that knee might prevent disease or its progression there. Our aim was to determine how often persons with medial OA on 1 side had either concurrent or later medial OA on the contralateral side, and whether an intervention known to reduce medial loading in affected knees with medial OA might reduce medial loading in the contralateral knee. Lateral wedge insoles reduce loading across an affected medial knee but their effect on the contralateral knee is unknown. METHODS: To determine the proportion of persons with medial knee OA who had concurrent medial contralateral OA or developed contralateral medial OA later, we examined knee radiographs from the longitudinal Framingham Osteoarthritis Study. Then, to examine an approach to reducing medial load in the contralateral knee, 51 people from a separate study with painful medial tibiofemoral OA underwent gait analysis wearing bilateral controlled shoes with no insoles, and then with 2 types of wedge insoles laterally posted by 5°. Primary outcome was the external knee adduction moment (EKAM) in the contralateral knee. Nonparametric CI were constructed around the median differences in percentage change in the affected and contralateral sides. RESULTS: Of Framingham subjects with medial radiograph knee OA, 137/152 (90%) either had concurrent contralateral medial OA or developed it within 10 years. Of those with medial symptomatic knee OA, 43/67 (64%) had or developed the same disease state in the contralateral knee. Compared to a control shoe, medial loading was reduced substantially on both the affected (median percentage EKAM change -4.84%; 95% CI -11.33% to -0.65%) and contralateral sides (median percentage EKAM change -9.34%; 95% CI -10.57% to -6.45%). CONCLUSION: In persons with medial OA, the contralateral knee is also at high risk of medial OA. Bilateral reduction in medial loading in knees by use of strategies such as lateral wedge insoles might not only reduce medial load in affected knees but prevent knee OA or its progression on the contralateral side.

Automated detection of instantaneous gait events using time frequency analysis and manifold embedding.

Accelerometry is a widely used sensing modality in human biomechanics due to its portability, non-invasiveness, and accuracy. However, difficulties lie in signal variability and interpretation in relation to biomechanical events. In walking, heel strike and toe off are primary gait events where robust and accurate detection is essential for gait-related applications. This paper describes a novel and generic event detection algorithm applicable to signals from tri-axial accelerometers placed on the foot, ankle, shank or waist. Data from healthy subjects undergoing multiple walking trials on flat and inclined, as well as smooth and tactile paving surfaces is acquired for experimentation. The benchmark timings at which heel strike and toe off occur, are determined using kinematic data recorded from a motion capture system. The algorithm extracts features from each of the acceleration signals using a continuous wavelet transform over a wide range of scales. A locality preserving embedding method is then applied to reduce the high dimensionality caused by the multiple scales while preserving salient features for classification. A simple Gaussian mixture model is then trained to classify each of the time samples into heel strike, toe off or no event categories. Results show good detection and temporal accuracies for different sensor locations and different walking terrains.

Foot kinematics in patients with two patterns of pathological plantar hyperkeratosis.

BACKGROUND: The Root paradigm of foot function continues to underpin the majority of clinical foot biomechanics practice and foot orthotic therapy. There are great number of assumptions in this popular paradigm, most of which have not been thoroughly tested. One component supposes that patterns of plantar pressure and associated hyperkeratosis lesions should be associated with distinct rearfoot, mid foot, first metatarsal and hallux kinematic patterns. Our aim was to investigate the extent to which this was true. METHODS: Twenty-seven subjects with planter pathological hyperkeratosis were recruited into one of two groups. Group 1 displayed pathological plantar hyperkeratosis only under metatarsal heads 2, 3 and 4 (n = 14). Group 2 displayed pathological plantar hyperkeratosis only under the 1st and 5th metatarsal heads (n = 13). Foot kinematics were measured using reflective markers on the leg, heel, midfoot, first metatarsal and hallux. RESULTS: The kinematic data failed to identify distinct differences between these two groups of subjects, however there were several subtle (generally <3°) differences in kinematic data between these groups. Group 1 displayed a less everted heel, a less abducted heel and a more plantarflexed heel compared to group 2, which is contrary to the Root paradigm. CONCLUSIONS: There was some evidence of small differences between planter pathological hyperkeratosis groups. Nevertheless, there was too much similarity between the kinematic data displayed in each group to classify them as distinct foot types as the current clinical paradigm proposes.

Automated nonlinear feature generation and classification of foot pressure lesions.

Plantar lesions induced by biomechanical dysfunction pose a considerable socioeconomic health care challenge, and failure to detect lesions early can have significant effects on patient prognoses. Most of the previous works on plantar lesion identification employed the analysis of biomechanical microenvironment variables like pressure and thermal fields. This paper focuses on foot kinematics and applies kernel principal component analysis (KPCA) for nonlinear dimensionality reduction of features, followed by Fisher's linear discriminant analysis for the classification of patients with different types of foot lesions, in order to establish an association between foot motion and lesion formation. Performance comparisons are made using leave-one-out cross-validation. Results show that the proposed method can lead to approximately 94% correct classification rates, with a reduction of feature dimensionality from 2100 to 46, without any manual preprocessing or elaborate feature extraction methods. The results imply that foot kinematics contain information that is highly relevant to pathology classification and also that the nonlinear KPCA approach has considerable power in unraveling abstract biomechanical features into a relatively low-dimensional pathology-relevant space.

An instance-based algorithm with auxiliary similarity information for the estimation of gait kinematics from wearable sensors.

Wearable human movement measurement systems are increasingly popular as a means of capturing human movement data in real-world situations. Previous work has attempted to estimate segment kinematics during walking from foot acceleration and angular velocity data. In this paper, we propose a novel neural network [GRNN with Auxiliary Similarity Information (GASI)] that estimates joint kinematics by taking account of proximity and gait trajectory slope information through adaptive weighting. Furthermore, multiple kernel bandwidth parameters are used that can adapt to the local data density. To demonstrate the value of the GASI algorithm, hip, knee, and ankle joint motions are estimated from acceleration and angular velocity data for the foot and shank, collected using commercially available wearable sensors. Reference hip, knee, and ankle kinematic data were obtained using externally mounted reflective markers and infrared cameras for subjects while they walked at different speeds. The results provide further evidence that a neural net approach to the estimation of joint kinematics is feasible and shows promise, but other practical issues must be addressed before this approach is mature enough for clinical implementation. Furthermore, they demonstrate the utility of the new GASI algorithm for making estimates from continuous periodic data that include noise and a significant level of variability.

Clinical and experimental models of the midtarsal joint: proposed terms of reference and associated terminology.

Recent debate and literature have provided impetus to the growing body of thought that we should not model the midtarsal joint as having two simultaneous axes of rotation but as having a single instantaneous axis of rotation. Building on this concept, we present new reference terminology and propose that descriptions of midtarsal joint kinetics and kinematics relate to moments and motion in the cardinal body planes as defined by the x-, y-, and z-axes of the local reference system of the calcaneus. This replaces the existing terminology that describes the oblique and longitudinal axes for the midtarsal joint. The purpose of the new terms of reference and terminology is to aid in the communication of ideas and concepts regarding the biomechanics of the midtarsal joint among clinicians and between researchers and clinicians. It will also allow integration of the midtarsal joint into the emerging biomechanical model of the lower limb, promote consistency in discussions of the joint, and ease understanding of the interrelationships between the kinetics and the kinematics of the articulations in the foot and lower limb and their relationship to pathology and clinical practice.

Automated design of robust discriminant analysis classifier for foot pressure lesions using kinematic data.

In the recent years, the use of motion tracking systems for acquisition of functional biomechanical gait data, has received increasing interest due to the richness and accuracy of the measured kinematic information. However, costs frequently restrict the number of subjects employed, and this makes the dimensionality of the collected data far higher than the available samples. This paper applies discriminant analysis algorithms to the classification of patients with different types of foot lesions, in order to establish an association between foot motion and lesion formation. With primary attention to small sample size situations, we compare different types of Bayesian classifiers and evaluate their performance with various dimensionality reduction techniques for feature extraction, as well as search methods for selection of raw kinematic variables. Finally, we propose a novel integrated method which fine-tunes the classifier parameters and selects the most relevant kinematic variables simultaneously. Performance comparisons are using robust resampling techniques such as Bootstrap 632+ and k-fold cross-validation. Results from experimentations with lesion subjects suffering from pathological plantar hyperkeratosis, show that the proposed method can lead to approximately 96% correct classification rates with less than 10% of the original features.

Transverse plane motion at the ankle joint.

The ankle is often considered to have little or no capacity to move in the transverse plane. This is clear in the persistent concept that it is the role of the subtalar joint to accommodate the transverse plane motion of the leg while the foot remains in a fixed transverse plane position on the floor. We present data from noninvasive in vivo study of the ankle subtalar complex during standing internal and external rotation of the leg and study of the ankle subtalar complex during walking. These data reinforce the results of cadaver study and invasive in vivo study of the ankle/subtalar complex. We suggest that the ankle is capable of considerable movement in the transverse plane (generally greater than 15 degrees) and that its role in the mechanism that allows the foot to remain in a fixed transverse plane position on the floor while the leg rotates in the transverse plane, is not simply the transfer of the transverse plane moment to the subtalar joint, but is accommodation of some of the necessary movement.

Outcomes of hyaluronan therapy in diabetic foot wounds.

The purpose of this study was to evaluate outcomes of persons with neuropathic diabetic foot wounds treated with a hyaluronan-containing dressing. Data were abstracted for 36 patients with diabetes, 72.2% male, aged 60.0+/-10.7 years and a mean glycated hemoglobin (HbA(1c)) of 9.5+/-2.5% presenting for care at two large, multidisciplinary wound care centers. All patients received surgical debridement for their diabetic foot wounds and were placed on therapy consisting of hyaluronan dressing (Hyalofill, Convatec, USA) with dressing changes taking place every other day. Outcomes evaluated included time to complete wound closure and proportion of patients achieving wound closure in 20 weeks. Hyalofill therapy was used until the wound bed achieved 100% granulation tissue. Therapy was then followed by a moisture-retentive dressing until complete epithelialization. In total, 75.0% of wounds measuring a mean 2.2+/-2.2 cm(2) healed in the 20-week evaluation period. Of those that healed in this period, healing took place in a mean 10.0+/-4.8 weeks. The average duration of Hyalofill therapy in all patients was 8.6+/-4.2 weeks. Deeper (UT Grade 2A) wounds were over 15 times less likely to heal than superficial (1A) wounds (94.7 vs. 52.9%, Odds Ratio=15.9, 95% Confidence Interval=1.7-142.8, P=0.006). We conclude that a regimen consisting of moist wound healing using hyaluronan-containing dressings may be a useful adjunct to appropriate diabetic foot ulcer care. We await the completion of a multicenter randomized controlled trial in this area to either support or refute this initial assessment.