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Evaluation of interventions to enhance recruitment or reduce attrition within randomised controlled trials is uncommon. A number of initiatives have tried to increase this evidence base by encouraging the embedding of such trials within trials evaluating healthcare interventions. The NIHR-funded REFORM study recruited and followed up participants by mailing out invitation packs and questionnaires to participants. We undertook four embedded studies during the recruitment and follow-up phases: (1) Exploration of the feasibility and validity of the EQ5D-5L: 332 participants were sent a baseline questionnaire containing both the EQ5D-5L and the EQ5D-3L; (2) Two embedded trials evaluating i) the effectiveness of an enhanced patient information sheet (PIS) and ii) pre-notification with a study newsletter, to increase recruitment to the trial; and (3) An embedded factorial trial evaluating the effectiveness of a Post-it® note and/or newsletter to increase questionnaire response rates and minimise attrition to the trial. The EQ5D-5L and Post-It® note studies were easily incorporated using in-house funding. The PIS study required £6,500 funding from the MRC START team. Undertaking these studies did cause some delay to the main study, but not to the detriment of the study. To date, results for only the PIS and pre-notification studies are available, and no statistically significant differences have been observed. We have demonstrated that it can be relatively easy to embed several trials within a trial. Whilst funding in some cases may be an issue, can provide useful learning experiences for inexperienced researchers and inform future studies and they do produce academic publications.

Background Dynamic joint loading, particularly the external knee adduction moment (KAM), is an important surrogate measure for the medio-lateral distribution of force across the knee joint in people with knee osteoarthritis (OA). Foot motion may alter the load on the medial tibiofemoral joint and hence affect the KAM. Therefore, this study aimed to investigate the relationship between tibia, rearfoot and forefoot motion in the frontal and transverse planes and the KAM in people with medial compartment knee OA. Method Motion of the knee, tibia, rearfoot and forefoot and knee moments were evaluated in 32 patients with clinically and radiographically-confirmed OA, predominantly in the medial compartment. Pearson’s correlation coefficient was used to investigate the association between peak values of tibia, rearfoot and forefoot motion in the frontal and transverse planes and 1st peak KAM, 2nd peak KAM, and the knee adduction angular impulse (KAAI). Results Lateral tilt of the tibia was significantly associated with increased 1st peak KAM (r = 0.60, p

Background There are several clinical and radiological methods available to classify foot posture in research, however there is no clear strategy for selecting the most appropriate measurements. Therefore, the aim of this study was to develop a foot screening protocol to distinguish between participants with normal- and flat-arched feet who would then subsequently be recruited into a series of laboratory-based gait studies. Methods The foot posture of ninety-one asymptomatic young adults was assessed using two clinical measurements (normalised navicular height and arch index) and four radiological measurements taken from antero-posterior and lateral x-rays (talus-second metatarsal angle, talo-navicular coverage angle, calcaneal inclination angle and calcaneal-first metatarsal angle). Normative foot posture values were taken from the literature and used to recruit participants with normal-arched feet. Data from these participants were subsequently used to define the boundary between normal- and flat-arched feet. This information was then used to recruit participants with flat-arched feet. The relationship between the clinical and radiographic measures of foot posture was also explored. Results Thirty-two participants were recruited to the normal-arched study, 31 qualified for the flat-arched study and 28 participants were classified as having neither normal- or flat-arched feet and were not suitable for either study. The values obtained from the two clinical and four radiological measurements established two clearly defined foot posture groups. Correlations among clinical and radiological measures were significant (p < 0.05) and ranged from r = 0.24 to 0.70. Interestingly, the clinical measures were more strongly associated with the radiographic angles obtained from the lateral view. Conclusion This foot screening protocol provides a coherent strategy for researchers planning to recruit participants with normal- and flat-arched feet. However, further research is required to determine whether foot posture variations in the sagittal, transverse or both planes provide the best descriptor of the flat foot.

Background The Foot Posture Index (FPI) is a validated method for quantifying standing foot posture, and is being used in a variety of clinical settings. There have however, been no normative data available to date for comparison and reference. This study aimed to establish normative FPI reference values. Methods Studies reporting FPI data were identified by searching online databases. Nine authors contributed anonymised versions of their original datasets comprising 1648 individual observations. The datasets included information relating to centre, age, gender, pathology (if relevant), FPI scores and body mass index (BMI) where available. FPI total scores were transformed to interval logit scores as per the Rasch model and normal ranges were defined. Comparisons between groups employed t-tests or ANOVA models as appropriate and data were explored descriptively and graphically. Results The main analysis based on a normal healthy population (n = 619) confirmed that a slightly pronated foot posture is the normal position at rest (mean back transformed FPI raw score = +4). A 'U' shaped relationship existed for age, with minors and older adults exhibiting significantly higher FPI scores than the general adult population (F = 51.07, p < 0.001). There was no difference between the FPI scores of males and females (2.3 versus 2.5; t = -1.44, p = 0.149). No relationship was found between the FPI and BMI. Systematic differences from the adult normals were confirmed in patients with neurogenic and idiopathic cavus (F = 216.981, p < 0.001), indicating some sensitivity of the instrument to detect a posturally pathological population. Conclusion A set of population norms for children, adults and older people have been derived from a large sample. Foot posture is related to age and the presence of pathology, but not influenced by gender or BMI. The normative values identified may assist in classifying foot type for the purpose of research and clinical decision making.

Background The Manchester Foot Pain and Disability Index (MFPDI) has been used to determine the prevalence of disabling foot pain in several studies, however there is some debate as to which case definition is most appropriate. The objective of this study was to explore age and gender differences in the proportion of people with disabling foot pain using three different case definitions of the MFPDI and for each individual MFPDI item. Methods A random sample of 223 participants aged 27 to 90 years (88 males and 135 females) from the North West Adelaide Health Study, who reported having pain, aching or stiffness in either of their feet on most days in the last month, completed the MFPDI by telephone interview. The proportion of people with disabling foot pain was determined using three definitions: (i) Definition A-at least one of the 17 items documented on at least some days in the last month; (ii) Definition B-at least one of the 17 items documented on most/every day(s) in the last month, and; (iii) Definition C-at least one of the ten functional limitation items documented on most/every day(s) in the last month. Cross-tabulations and chi-squared statistics were used to explore differences in responses to the MFPDI items according to age and gender. Results The proportion of people with disabling foot pain according to each definition was as follows: Definition A (100%), Definition B (95.1%) and Definition C (77.6%). Definition C was most sensitive to age and gender differences. Exploration of individual MFPDI items indicated that age significantly affected both the pain intensity and functional limitation items, with younger people more likely to report their foot pain being worse in the morning, and older people more likely to report functional limitations. Although gender did not influence responses to the personal appearance items, women were more likely report functional limitations than men. Conclusions Definition C of the MFPDI is more sensitive to age and gender differences in the proportion of people with disabling foot pain, and would therefore seem to be the most appropriate case definition to use in epidemiological studies involving a broad age range of participants.

Since the publication of our Research article [1], the copyright of the Manchester Foot Pain and Disability Index (MFPDI) now states a licence agreement is required for publication. As a result, Additional file 2 has been removed, the English language version of the MFPDI can be found through the ISIS Outcomes website [2].

Background Ill-fitting footwear is a common problem in older people. The objective of this study was to determine the accuracy of shoe fitting in older people by comparing the dimensions of allocated shoes to foot dimensions obtained with a three-dimensional (3D) scanner. Methods The shoe sizes of 56 older people were determined with the Brannock device®, and weightbearing foot scans were obtained with the FotoScan 3D scanner (Precision 3D Ltd, Weston-super-mare, UK). Participants were provided with a pair of shoes (Dr Comfort®, Vista, CA, USA), available in three width fittings (medium, wide and extra wide). The dimensions (length, ball width and ball girth) of the allocated shoes were documented according to the last measurements provided by the manufacturer. Mean differences between last dimensions and foot dimensions obtained with the 3D scanner were calculated to provide an indication of shoe fitting accuracy. Participants were also asked to report their perception of shoe fit and comfort, using 100 mm visual analogue scales (VAS). Results Shoe size ranged from US size 7 to 14 for men and 5.5 to 11 for women. The allocated shoes were significantly longer than the foot (mean 23.6 mm, 95% confidence interval [CI] 22.1 to 25.2; t55 = 30.3, p

Background The high incidence of falls associated with Parkinson’s disease (PD) increases the risk of injuries and immobility and compromises quality of life. Although falls education and strengthening programs have shown some benefit in healthy older people, the ability of physical therapy interventions in home settings to reduce falls and improve mobility in people with Parkinson’s has not been convincingly demonstrated. Methods/design 180 community living people with PD will be randomly allocated to receive either a home-based integrated rehabilitation program (progressive resistance strength training, movement strategy training and falls education) or a home-based life skills program (control intervention). Both programs comprise one hour of treatment and one hour of structured homework per week over six weeks of home therapy. Blinded assessments occurring before therapy commences, the week after completion of therapy and 12 months following intervention will establish both the immediate and long-term benefits of home-based rehabilitation. The number of falls, number of repeat falls, falls rate and time to first fall will be the primary measures used to quantify outcome. The economic costs associated with injurious falls, and the costs of running the integrated rehabilitation program from a health system perspective will be established. The effects of intervention on motor and global disability and on quality of life will also be examined. Discussion This study will provide new evidence on the outcomes and cost effectiveness of home-based movement rehabilitation programs for people living with PD. Trial registration The trial is registered on the Australian and New Zealand Clinical Trials Registry (ACTRN12608000390381).

Background Few population-based studies have examined the prevalence of foot pain in the general community. The aims of this study were therefore to determine the prevalence, correlates and impact of foot pain in a population-based sample of people aged 18 years and over living in the northwest region of Adelaide, South Australia. Methods The North West Adelaide Health Study is a representative longitudinal cohort study of n = 4,060 people randomly selected and recruited by telephone interview. The second stage of data collection on this cohort was undertaken between mid 2004 and early 2006. In this phase, information regarding the prevalence of musculoskeletal conditions was included. Overall, n = 3,206 participants returned to the clinic during the second visit, and as part of the assessment were asked to report whether they had pain, aching or stiffness on most days in either of their feet. Data were also collected on body mass index (BMI); major medical conditions; other joint symptoms and health-related quality of life (the Medical Outcomes Study Short Form 36 [SF-36]). Results Overall, 17.4% (95% confidence interval 16.2 – 18.8) of participants indicated that they had foot pain, aching or stiffness in either of their feet. Females, those aged 50 years and over, classified as obese and who reported knee, hip and back pain were all significantly more likely to report foot pain. Respondents with foot pain scored lower on all domains of the SF-36 after adjustment for age, sex and BMI. Conclusion Foot pain affects nearly one in five of people in the community, is associated with increased age, female sex, obesity and pain in other body regions, and has a significant detrimental impact on health-related quality of life.

midfoot (new=42%, old=44%), and contact area at the midfoot (new=51% and old=53%) and forefoot (new=11%, old=13%) compared to the shoe only condition. There were no significant differences between the old and new orthoses, with the exception of small but statistically significant increases in peak pressure at the heel (6%) and maximum force at the heel (5%) and forefoot (2%) in the old orthoses compared to the new orthoses.

Background Undertaking randomised controlled trials can be challenging. Many trials fail to recruit, there may be issues around consent, patient preferences and treatment comparisons. The patient preference and Zelen designs have attempted to address the issues around recruitment and patient preference. However the cohort multiple randomised controlled trial has been suggested as an alternative design. The REFORM study uses this design to evaluate the clinical and cost effectiveness of a multifaceted podiatry intervention consisting of an orthotic, foot and ankle exercises and footwear advice for the prevention of falls in the over 65.

Results At baseline, 26% of the sample reported foot problems. At follow-up, 37% remained free of foot problems, 36% had developed a new foot problem, 13% experienced resolution of their foot problems and 14% experienced persistent foot problems. Increase in BMI over the six year follow-up period was significantly associated with the development of new foot problems and the persistence of existing foot problems.

Background Osteoarthritis (OA) affecting of the first metatarsophalangeal joint (MTPJ), is a common and painful condition. Although several different treatments have been suggested throughout the literature, few have been adequately evaluated. Therefore, the aim of this study was to conduct a Cochrane review in order to determine the efficacy of treatments available for first MTPJ OA. Methods Randomised controlled trials, quasi-randomised trials, or controlled clinical trials that assessed treatment outcomes for first MTPJ OA were searched for across several electronic databases (to the 14th January 2010) (CENTRAL; MEDLINE; EMBASE; CINAHL; and PEDro). Participants of any age or gender with OA of the first MTPJ defined either radiographically or clinically were included in this review. Results Only one trial satisfactorily fulfilled the inclusion criteria and was included in this review. This trial evaluated the effectiveness of two physical therapy programs in 20 individuals with OA of the first MTPJ. Assessment outcomes included pain levels, first MTPJ range of motion and plantarflexion strength of the hallux. Mean differences at 4 weeks follow up were 3.80 points [95% CI: 2.74 to 4.86] for self reported pain, 28.30 degrees [95% CI: 21.37 to 35.23] for first MTPJ range of motion and 2.80 kilograms [95% CI; 2.13 to 3.47] for muscle strength. Although differences in outcomes between treatment and control groups were reported, the risk of bias was high. The trial failed to employ appropriate randomisation or adequate allocation concealment, used a relatively small sample and incorporated a short follow up (4 weeks). No adverse reactions were reported. Conclusions Only one quasi-randomised controlled trial for first MTPJ OA was found. The reviewed trial presented a high risk of bias, limiting the conclusions that could be drawn from the presented data. The inclusion of only one trial indicates the need for more robust randomised controlled trials to determine the efficacy of interventions for this condition.

Objective. Abnormal foot posture and function have been proposed as possible risk factors for low back pain, but this has not been examined in detail. The objective of this study was to explore the associations of foot posture and foot function with low back pain in 1930 members of the Framingham Study (2002–05). Methods. Low back pain, aching or stiffness on most days was documented on a body chart. Foot posture was categorized as normal, planus or cavus using static weight-bearing measurements of the arch index. Foot function was categorized as normal, pronated or supinated using the centre of pressure excursion index derived from dynamic foot pressure measurements. Sex-specific multivariate logistic regression models were used to examine the associations of foot posture, foot function and asymmetry with low back pain, adjusting for confounding variables. Results. Foot posture showed no association with low back pain. However, pronated foot function was associated with low back pain in women [odds ratio (OR) = 1.51, 95% CI 1.1, 2.07, P = 0.011] and this remained significant after adjusting for age, weight, smoking and depressive symptoms (OR = 1.48, 95% CI 1.07, 2.05, P = 0.018). Conclusion. These findings suggest that pronated foot function may contribute to low back symptoms in women. Interventions that modify foot function, such as orthoses, may therefore have a role in the prevention and treatment of low back pain.

Background Excessive foot pronation during gait is frequently linked to patellofemoral pain syndrome (PFPS) development, due a proposed coupling of increased foot pronation with increased tibial and femoral internal rotation. However, there is a paucity of research which has compared kinematics associated with foot pronation between individuals with PFPS and controls. The aim of this study was to compare forefoot, rearfoot and tibial kinematics associated with foot pronation between individuals with PFPS and controls.

Methods One hundred and fifty one participants with first MTPJ OA received an intra-articular injection of 1ml hylan GF 20 or saline. Potential predictors included intervention group, demographics, height weight, BMI, symptom duration and severity, the Foot Health Status Questionnaire (FHSQ), first MTPJ dorsiflexion range of motion and radiographic OA severity (osteophytes and joint space narrowing as individual features in either the dorsal and lateral view, or as a combination, where scores of 2 for any feature in any view was considered ‘definite’ OA). The primary measure was a 15-point change in symptoms scale (range -7‘a very great deal worse’ to +7 – ‘a very great deal better’) at 12-weeks, dichotomised with scores of 3 defined as treatment success. Predictor variables were initially analysed with univariate analyses. Significant variables were than entered into a backward stepwise multivariate logistic regression.

Background Various foot orthoses have been shown to alter tibialis anterior and peroneus longus electromyographic (EMG) muscle activity during walking. However, it is unclear whether these changes represent optimisation in muscle function. Therefore, two studies were conducted to determine; (i) whether people with flat-arched feet display altered muscle activity compared to those with normal-arched feet during gait and (ii) whether foot orthoses change muscle activity in people with flatarched feet towards a pattern observed in those with normal-arched feet.