Podiatry
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Item The effect of Custom Foot Orthotic Materials on Running Economy, Comfort, Running Mechanics, and Performance(Queen Margaret University, Edinburgh, 2024-10) Van Alsenoy, Ken K.Custom foot orthoses (CFOs) possess a unique surface geometry tailored to an individual’s foot, serving as an interface to redirect ground reaction forces. Their effect is defined by altering the orthotic shape in contact with the foot and choosing material characteristics to redirect or dampen these forces. In sports, CFOs have proven effective at mitigating injury risks and are part of a treatment plan for several lower limb and foot injuries. To date, empirical evidence for the impact of CFO materials on running and sprinting-related outcome measures is limited. The overarching aim of this PhD thesis wasto investigate the effect of CFO materials on running mechanics (kinetics and kinematics), running economy (RE), sprint performance, footwear comfort, and fatigue perception in uninjured recreational runners. It comprises one systematic review and meta-analysis, and two double-blinded randomised controlled crossover studies, resulting in five peer-reviewed publications. In the systematic review (article 1), with a meta-analysis of four studies (three weak and one moderate quality) revealed that oxygen consumption during submaximal running is reduced in the most comfortable footwear condition compared with the least comfortable footwear (MD: -2.06 mL.kg−1 .min−1 ; 95%CI: - 3.71, -0.42; P = 0.01). This finding underscored the importance of measuring footwear comfort along other variables such as running mechanics and RE. Article two compared EVA and TPU CFOs on RE, running mechanics and comfort at two different running speeds. CFOs had no statistically significant effect on RE, irrespective of materials or running speed. Peak braking force reduced with EVA by ∼4% compared to CON (P = 0.027). Propulsive loading rate increased with TPU ∼18% compared to CON (P = 0.009). Footwear comfort remained consistent across all conditions. Although these results were associated with moderately low submaximal running speeds in a rested state, examining the effects of CFOs on similar outcome measures when runners are fatigued or engaged in higher intensity exercises like sprinting appeared justified. Article three and four explored fatigue perception after repeated sprint exercises and constant velocity running, respectively. In Article three, both EVA and TPU increased sprint distance by respectively ∼0.6m (P = 0.004) and ∼0.4m (P = 0.018), without altering fatigue-induced mechanical changes. Article fourfound no significant differences in outcome measures between fatigued and fresh conditions, except for a reduction in loading rate (P = 0.046), increased minute ventilation (P = 0.020) and increased breathing frequency (P = 0.019). Further research focused on a hybrid (HYB) CFO, combining EVA in the heel and TPU in the forefoot. Article five showed reduced peak frontal plane angles (ankle eversion: P < 0.001, 2 = 0.72) and angular velocities (ankle eversion: P < 0.001, 2 = 0.64; ankle inversion: P < 0.001, 2 = 0.60) between conditions. Statistical non-parametric mapping revealed that HYB resulted in the largest proportions of significant changes during stance, when compared to control. In conclusion, the studies in this PhD thesis enhances the understanding of EVA, TPU and HYB CFOs in healthy recreational runners. For athletes, the findings could potentially expand the scope of foot orthoses use during sport activity, since it is not affecting RE. The small yet significant changes in running mechanics that were associated with material choice, could help guide clinicians in CFO prescription, whether using single materials or in combination.Item Manipulation of the foot in the treatment of patients with Morton’s neuroma(Queen Margaret University, Edinburgh, 2024-06-26) Cashley, DavidIntroduction Manipulative therapy’s rationale is pragmatically appealing as a non-invasive treatment for Morton’s neuroma (MN), involving targeted manipulations of relevant joints. Nevertheless, manipulation’s efficacy has received limited scrutiny. This thesis comprised four data-driven chapters offering novel investigations associated with manipulation as a treatment for MN. The latter included a critical appraisal of the clinimetric utility of pressure testing for discomfort thresholds (PTT) as a novel outcome in this context (n = 26; Chapter 5), an exploratory pragmatic controlled trial investigating Manipulation versus Steroid Injection in the treatment of patients with Morton’s neuroma focusing on self-reported pain levels (VAS) and PTT (n = 61; Chapter 6) and other PROMs reflecting functionality and health (Chapter 7). A final data chapter (Chapter 8) contributed secondary analyses of data in Chapters 6 and 7 exploring novel factors in enhanced clinical outcomes of non-surgical treatment of Morton’s neuroma using descriptive multivariate modelling and discriminant analysis. Method The thesis’s primary study (Chapters 6 and 7) featured an exploratory, pragmatic randomised controlled trial was designed to investigate the efficacy of an acute, short dosage (6, weekly episodes) of physiologically-principled manipulations, featuring discrete, high-velocity thrusting manoeuvres for treating Morton’s Neuroma. Adults electing treatment for Morton’s neuroma were randomly allocated to manipulative therapy (n = 29) or corticosteroid injection (n = 32). Baseline and follow-up (at 1·5, 3, 6, 9 and 12 months following treatment cessation) outcome measures of self-reported pain levels (VAS), pressure testing for discomfort thresholds (PTT) and functionality (walking and standing [MOxFQws], pain [MOxFQp)] and social interaction [MOxFQsi]; activities of daily living [FAAMdl], sports participation [FAAMspt] and general health [SF-36 PCS & MCS]) were measured ipsilaterally and by inventory. Results Chapters 6 and 7 showed that manipulation elicited substantive gains immediately after intervention (VAS [Cohen’s d, 3·3; 84·4%]; PTT [d, 2·3; 147·0%]; MOxFQws [d, 1·4; 52·8%]; MOxFQp [d, 1·3; 45·5%]; MOxFQsi [d, 0·9; 39·2%]) or accumulated during follow-up (FAAMdl [d, 2·2; 40·8%]; FAAMspt [d, 1·5; 66·1%]). Concomitant gains interactively for control participants were modest (d, 0·4 to 1·0; 16·6% to 45·9%) (p < 0·05 to p < 0·0005). Retention of improvements following manipulation cessation was substantial for all metrics, significantly better than baseline scores (VAS, PTT, MOxFQws, MOxFQp, MOxFQsi, FAAMdl, FAAMspt, SF-36 PCS and SF-36 MCS [d, 1·1 to 3·4; 40·8% to 152·3%]) and consistently exceeded that for corticosteroid injection (p < 0·01 to p < 0·001). Group mean intra-session and inter-day variability (V%) of PTT (Chapter 5) ranged between 6.8% and 13.6% for experienced and inexperienced test administrators, respectively, and suggested compromised precision amongst serial measurements of PTT over extended periods of time. Within Chapter 8, predictive multivariate modelling showed that in internal classification analyses, 88.9% of patients could be assigned correctly to high- and low-responders to treatment. Conclusion (i) Manipulation elicited significant and clinically relevant improvements and retention in self-reported levels of pain, discomfort and functionality for patients electing treatment for Morton’s neuroma; (ii) Exploratory multivariate modelling provided a significant prediction model for successful non-surgical treatment outcomes; (iii) Single measurements showed compromised precision amongst serial assessments of PTT.Item Development and validation of a prognostic model for stump healing in major lower limb amputation(Queen Margaret University, Edinburgh, 2016) Ashraff, SuhelIntroduction Stump healing is essential in patients with a lower limb amputation in order for them to mobilize again. Little research has been being done on factors affecting stump healing. The aim of this paper is to explore the effect of haematological makers as well as patient characteristics on stump healing after patients have undergone an amputation procedure. In addition, a practical model regarding factors that affect stump healing was developed. Methods Patients who underwent a major lower limb amputation (above knee and below knee) at the Royal Infirmary of Edinburgh from the period of 2006 to 2009 were included in this study. A prognostic model utilizing backward stepwise logistical regression was developed to measure the probability of lower limb stump healing. The relationship between the dependent and independent variables was identified using univariate and multivariate logistic regression. Hosmer and Lemeshow goodness of fit test and Receiver Operating Curve (ROC) was used in order to measure the effectiveness of the model. The model was validated with the prospective data of 100 patients that had undergone major lower limb amputation from the year 2010 and 2011 in Royal Infirmary of Edinburgh prospectively. Results In this study healing of the stump as defined was achieved in sixty three percent (63%) of patients. Univariate analysis found seven variables to be associated with lower limb stump healing (type of amputation, gender, hypertension, smoking, serum sodium, serum creatinine and serum High Density Lipid cholesterol (HDL)). A further four variables (age, diabetes xxv mellitus, white cell count and Prothrombin Time) were added to the model secondary to their strong clinical association with the stump healing. Three variables, namely serum sodium, serum creatinine and serum High Density Lipid cholesterol were identified which influenced stump healing. Patients with normal serum sodium were 75% more likely to have lower limb stump healing compared to that of patients with abnormal serum sodium (odds ratio [OR] 1.756; 95% confidence interval [CI] 1.048-2.942). Patients with normal serum creatinine were 66% more likely to have their stump healed (OR 1.664; 95% CI 0.94 to 2.946). The healing rate of patients with a normal level of serum High Density Lipid cholesterol was 75%, in contrast to patients with an aberrant level of serum High Density Lipids cholesterol (OR 1.753; 95% CI 1.061 to 2.895). The effectiveness of the retrospective stump-healing model was demonstrated by the area under the Receiver Operator Curve (0.612), which was supported by the Hosmer and Lemeshow goodness-of-fit test (p=0.879). In the prospective study, the model's discriminatory power was verified by the area under the Receiver Operator Curve (0.584) and Hosmer and Lemeshow goodness-of-fit test (p>0.05). Conclusion Serum sodium, serum High Density Lipid cholesterol and serum creatinine have a strong correlation with lower limb stump healing. However, serum sodium and serum High Density Lipid cholesterol secondary to multiple co-morbidities in this cohort group could be altered secondary to disease pathology itself. Further clinical research is necessary to evaluate the association of the risk factors with lower limb stump healing.Item A Study To Investigate Any Potential Effects On The Foot Of A Commonly Prescribed Off-The-Shelf Foot Orthosis In Patients With Early Diagnosed Rheumatoid Arthritis (RA)(Queen Margaret University, 2010) Cameron, VictoriaRheumatoid Arthritis (RA) frequently affects the foot. Custom moulded foot orthoses are effective in the management of the foot in RA; however the process of manufacture is lengthy, resulting in a delay of treatment for the patient. Offthe- shelf foot orthoses can be dispensed at the chairside on the day of diagnosis, so the patient receives treatment immediately. This is particularly crucial in RA, as early intervention is thought to improve patient outcomes in the long term. Anecdotal evidence suggests that Podiatrists do prescribe off-the-shelf foot orthoses for the management of the foot in RA; however no clinical studies exist to support this practice. The aim of this study was to investigate any potential effects on the foot of one commonly prescribed off-the-shelf foot orthosis, in patients with early RA. The type of off-the-shelf foot orthosis used was the Slimflex™ Plastic which has been shown to be a commonly used off-the-shelf foot orthosis by Podiatrists in the management of patients with RA in Scotland (Cameron et al. 2009). A total of 35 patients diagnosed with RA, with a mean age of 52.4 years (SD 13.3 years) and median disease duration of 0.5 years (IQR 1.8 years) were included. Local ethical approval was obtained. The study used a repeated measures design, with data collected at baseline, three months, and six months when patients were barefoot, shod, and with foot orthoses, to investigate any effects over time and between conditions. The primary objective was to investigate any potential effects of the Slimflex™ Plastic off-the-shelf foot orthosis on foot health related quality of life (QOL) using the Leeds Foot Impact Scale (LFIS) and foot pain using the Visual Analogue Scale (VAS). Plantar foot pressure measurement, walking speed, foot stability during walking and foot kinematics were then investigated to provide a rationale as to why foot health related QOL and foot pain may be affected with the foot orthosis. Data was analysed using SPSS version 16.0. Due to the known potential effects of medication, data was analysed for the total patient group (n=35) and subanalyses were then carried out on the group of patients who presented with stable medication throughout the study (n=12). This enabled any changes to be attributed to the foot orthosis alone and not because of any effects of medication. The LFIS and VAS for foot pain were significantly lower with the use of the foot orthosis over six months (p<0.05). Peak plantar pressure at the forefoot increased between barefoot and shod, and barefoot and foot orthosis (p<0.05), but decreased between shod and foot orthosis (p<0.05). Pressure time integral at the forefoot reduced with the foot orthosis (p<0.05). There was an increase in contact area at the midfoot and in hallux and lesser toe contact area, with the orthosis (p<0.05). Walking speed also increased over the six months (p<0.05). Preliminary findings indicated that the orthosis may affect foot stability during walking, and a case study implied that the foot orthosis positively affects foot kinematics. This study suggests that the Slimflex™ Plastic off-the-shelf foot orthosis is effective in the management of the foot in early RA, according to the measured variables in this study.Item Development of a prognostic model for fistula maturation in patients with advanced renal failure(Queen Margaret University, Edinburgh, 2014) Siddiqui, Muhammad A.A suitable type of vascular access has to be created to establish a connection between the circulation system of the patient and the haemodialysis cycle. The arteriovenous fistula (AVF) is considered to provide the best long-term functional vascular access, with reduced risk of thrombosis or infection and cost-effective. However, significant numbers of AVF, which fail to develop sufficiently for dialysis, are 28-53% of cases. This study aimed to explore the potential influence of blood markers and factors on the maturation of AVF, in patients who have undergone vascular access surgery and to develop and validate a prognostic model to determine the success of AVF maturation.Item Person-centred goal setting for exercise after stroke(Queen Margaret University, Edinburgh, 2014) Sugavanam, Thava PriyaClinical guidelines and policies recommend exercise after stroke. Person-centred goal setting may facilitate the uptake and maintenance of physical activity. The aim of this work was to design and evaluate a goal setting intervention in an exercise after stroke setting. Five interlinked studies were undertaken within the development and feasibility stages of the MRC framework of complex interventions. A systematic review examined 17 observational studies (11 quantitative, six qualitative) for the effects and experiences of goal setting in stroke rehabilitation (study one). Despite some positive effects, no firm conclusion could be reached regarding its effectiveness. Patients and professionals differed in their experiences. Barriers to goal setting outnumbered facilitators. The lack of a standardised goal setting method in stroke rehabilitation was highlighted. A goal setting intervention tailored to exercise after stroke was developed in study two, based on: findings from study one, Bandura’s Social Cognitive Theory and the Canadian Occupational Performance Measure. The intervention components were: dedicated time, patient education, patient involvement, regular follow-up, and a purpose-designed workbook. This intervention was piloted in study three alongside validation of the activPAL™ activity monitor with 12 stroke survivors. The intervention did not require modification. Only two variables of the activPAL™ (time spent in sitting and upright) had acceptable validity and reliability. Feasibility of the intervention and users’ experiences were investigated in study four with four stroke survivors, using mixed methods case studies. Intervention delivery and compliance were acceptable with no adverse effects. Findings regarding acceptability and content suggested a need for further work. Participants’ interest and engagement in goal setting were influenced by their familiarity with goal setting, interest in physical activity, functional ability and levels of self-efficacy, highlighting the individualisation required within goal setting. Experiences of exercise professionals involved in exercise after stroke regarding goal setting were explored in study five through three focus groups (n=6; n=6; n=3). Although goal setting was viewed positively, participants felt that its potential effectiveness was not always translated into practice due to barriers encountered: clients’ readiness to change, professionals’ lack of knowledge about stroke and a number of organisational factors. Suggestions to improve goal setting in practice were discussed. This work has enhanced our understanding of goal setting as a complex intervention. Recognition of the potential benefits of goal setting by both service users and providers, amidst the challenges, argues in favour of goal setting in the exercise after stroke setting. Areas for further research have been discussed.Item The role of pro-inflammatoy cytokines and autoimmune antibodies in diabetic peripheral neuropathy(Queen Margaret University, Edinburgh, 2014) Janahi, NoorIntroduction – The pathogenetic vision of diabetes mellitus has changed in the last few years, with inflammatory and autoimmunity pathways playing roles in the development and progression of diabetic complications. This study was conducted to investigate whether inflammation and/or autoimmunity are associated with the pathogenesis of human diabetic peripheral neuropathy. Methods – A cross-sectional analysis was initially conducted to explore the population of patients with diabetes mellitus in the Kingdom of Bahrain. The demographics of patients diagnosed with diabetes mellitus in the Royal Medical Services-Bahrain Defence Force Hospital were randomly collected from 500 record cards. Case-control analysis included three groups: 30 patients with diabetic peripheral neuropathy, 30 patients with diabetes mellitus without neuropathy, and 30 healthy controls. Blood analysis was conducted to compare the levels of pro-inflammatory markers and autoimmune markers between the three groups. Secondary analysis investigated the correlations between the level of markers and sample demographics and neurological manifestations. Due to the limited time and financial resources available, this research was considered as a pilot/exploratory study encouraging further investigations to take place in the near future. Results – From the 500 sample initially selected, 48% were male (n=242) and 52% (n= 258) were female. The mean age was 55 ± 14 years and the mean BMI was 35 ± 9 kg/m². Type I DM was present in 8% (n=38) only as opposed to 92% (n=462) who had type II DM. From the sample randomly selected, 76% of the patients had other medical complications, the commonest being peripheral neuropathy; 26% (n=186) followed by vascular insufficiency; 20% (n=141). Case control analysis demonstrated very highly significant differences between the three groups in the levels of IL-6, IL-8 and IL-1β (p<0.001), highly significant differences in the levels of TNF-α, IFN-ɤ (p<0.01), and a significant difference in the levels of CRP (p<0.05). Highly significant differences between the percentages of positive and negative autoimmune antibodies (ANA) between the three groups were observed. The odds of positive values of ANAs in the neuropathy group were 50 times higher when compared to control groups. Secondary analysis detected a number of significant relationships between the levels of pro-inflammatory markers and sample demographics. Highly significant correlations were found to be associated with neurological characteristics in the neuropathy group at the levels of CRP, IL-8, and IL-1β. Conclusion – The present study demonstrated that human peripheral diabetic neuropathy is associated with increased biochemical markers of inflammation and autoimmunity. Furthermore, painful neuropathy may be associated with further increase in inflammation. These results indicate that inflammation and autoimmunity may be important contributors in the development of peripheral neuropathy in diabetes mellitus. The new pathogenic factors may lead to the consideration of new management plans involving new therapeutic approaches and disease markers.Item A single blinded randomised controlled trial, to investigate the clinical effectiveness of pre-formed semi-rigid foot orthoses, on pain, quality of life and the dynamics of gait of patients diagnosed with juvenile idiopathic arthritis (JIA)”.(Queen Margaret University, 2013) Coda, AndreaIntroduction - Currently there is limited evidence supporting podiatric treatment of children with JIA. The foot orthoses (FOs) prescribed to JIA children so far appeared to be very expensive and required long time to manufacture before the fitting. This randomised controlled trial (RCT) aimed to determine whether pre-formed FOs that can be prescribed at chair side, impacted on pain, quality of life (primary outcomes) and/or gait-parameters (secondary outcomes) in children affected by JIA. Methods - The study took place at the Gait Analysis laboratory at Queen Margaret University – Edinburgh and at the TORT Centre, Ninewells Hospital-Dundee. Children with JIA were diagnosed according to the ILAR criteria. Intervention was blinded to the patients. The trial group received Slimflex-plus FOs, with the addition of chair side corrections and the control FOs supplied were made with leather board (1mm thick) only. Both FOs had the same black EVA top cover. Primary outcomes were investigated using validated questionnaires (VAS, CHAQ and PedsQL). Tekscan™ equipment (F-Scan™ and HR Walkway®) measured secondary outcomes in-shoe pressure and force data with and without FOs intervention. Multiple foot strikes and repetitive gait patterns were compared pre and post-treatment. Primary and secondary outcome measures were recorded at baseline, 3rd and 6th month’s period. Results - Sixty children were recruited; 48.3% (n=29) control and 51.7% (n=31) active treatment group. Within the control group 20.7% (n=6) of patients were male. Within the active treatment group, 29% (n=9) subjects were male. Age ranged between 5 to 18 years, median age for the control group was 11 (range=12.90) and for the trial group were 11.50 (range=12.11). In order to attribute any effect solely on the FOs intervention, details of changes of medication and/or new joint injections were recorded during the trial. In the control group 65.5% (n=19) were considered to be prescribed with stable medications. Similarly, amongst children receiving active treatment 74.2% (n=23) were deemed to be taking stable medications. Overall, 99.4% (n=179/180) appointments were completed, only one subject did not attend the 6 month session. Significant improvement was identified in the primary outcomes favouring active treatment with regards to pain and quality of life measures: VAS (p<0.05); CHAQ (p<0.05); PedsQL paediatric-generic (p<0.05) Peds paediatric rheumatology (p<0.05); PedsQL parent-generic (p<0.05); PedsQL parent-rheumatology (p<0.05). In all these quality of life tools where p<0.05, clinical significance was also obtained. Significant differences were also identified between the groups for gait time, stance time, total plantar surface, heel contact, midfoot, 5th metatarsal head and distal phalanx. Discussion - The results strongly suggest that FOs are effective in improving pain, quality of life and most gait parameters in JIA children. FOs can be customised at chair-side so JIA children can receive immediate podiatric benefit from the same day of the biomechanical assessment. Compliancy rate proved to be extremely high confirming that the podiatric treatment is well accepted by JIA children. Conclusion - Primary and secondary outcome’s results, strongly support the use of FOs in the treatment of JIA children, which highlights the important role of the podiatrists within the multidisciplinary team in paediatric rheumatology.Item The development of a system to measure the effects of plantar foot pressure on the microcirculation of the foot(Queen Margaret University, 2006) Santos, DerekAn investigation into the effects of plantar foot pressure on the microcirculation of healthy subjects and patients with Rheumatoid Arthritis was carried out. In the light of no equipment available to carry out this study a new system was developed. A shoe device was built with a combined pressure/skin blood flow transducer embedded in a three-tier piston mechanism in the heel so that plantar foot pressure could be applied/removed and quantified. The skin blood flow transducer made contact with the skin and was able to collect data about the microcirculatory state of the skin. The first system developed consisted of the laser Doppler Fluxmeter (Moor Instruments Ltd., UK) used to collect skin blood flow information and incorporating a strain gauge (Kyowa Electronic Instruments Co. Ltd., Japan) to quantify plantar foot pressure applied to the centre of the heel. This system was visually/sound synchronised and due to the time delay error it was modified. For the final system developed, the strain gauge was replaced with a custom-made Novel capacitative transducer (Novel, Germany) to quantify pressure. This allowed for the pressure system to be electronically synchronised in real time with the laser Doppler fluxmeter using an electronic synchronisation box. A number of studies were carried out to validate the systems. The developed systems were used to: (a) investigate the effects of the venoarteriolar response in healthy subjects with regards to the effects of plantar foot pressure on skin blood flow. The study concluded that subject positioning (that is, supine or semi-weight bearing) has an effect on how the microcirculation of the skin reacts to applied pressure. Thus, studies investigating the effects of external pressure on skin blood flow must have their subjects in a position that is related to what is being studies; (b) investigate the effects of plantar foot pressure on skin blood flow in patients with Rheumatoid Arthritis. A healthy control group was compared with a cohort of patients with Rheumatoid Arthritis with no evidence of vasculitis. The study concluded that there were no significant differences between both groups. A number of articles have been published from this thesis (see Appendix 14).