Joanne Paton

Effectiveness of insoles used for the prevention of ulceration in the neuropathic diabetic foot: a systematic review.

CONTEXT Ulceration can be a debilitating and costly complication of the neuropathic diabetic foot. Insoles inserted into footwear are routinely used in clinical practice to help to prevent ulceration. AIM AND SCOPE OF THE REVIEW: This review evaluated the effectiveness of insoles used for the prevention of ulcer in the neuropathic diabetic foot. METHODS Databases were searched from inception to 2008, supplemented by hand searching of references and grey literature. Data extraction and methodological quality assessment were independently conducted by two reviewers following the recommendations of the Centre for Reviews and Dissemination. RESULTS A total of five trials met the inclusion criteria: two randomised control trials (RCTs), two case control studies, and one follow-up study. The methodological quality of the majority of studies was poor. Omitted details regarding the generalisability of results made study comparison and inference to practice difficult. There is a small amount of limited evidence indicating that insoles are effective in reducing incidence of ulceration and reducing plantar peak pressures in the diabetic neuropathic foot. No study included economic analysis or patient-based outcome measures. CONCLUSIONS Insoles appear of use for the prevention of neuropathic diabetic foot ulceration, although evidence is limited. Clinical recommendation regarding type and specification of insole is not possible at this time. There is an essential need for a large well-designed RCT comparing different types of commonly used insole for the prevention of ulceration in the diabetic neuropathic foot. Outcome measures should include patient perceptions of the effectiveness and cost-effectiveness analysis.

A comparison of customised and prefabricated insoles to reduce risk factors for neuropathic diabetic foot ulceration: a participant-blinded randomised controlled trial

BackgroundNeuropathic diabetic foot ulceration may be prevented if the mechanical stress transmitted to the plantar tissues is reduced. Insole therapy is one practical method commonly used to reduce plantar loads and ulceration risk. The type of insole best suited to achieve this is unknown. This trial compared custom-made functional insoles with prefabricated insoles to reduce risk factors for ulceration of neuropathic diabetic feet.MethodA participant-blinded randomised controlled trial recruited 119 neuropathic participants with diabetes who were randomly allocated to custom-made functional or prefabricated insoles. Data were collected at issue and six month follow-up using the F-scan in-shoe pressure measurement system. Primary outcomes were: peak pressure, forefoot pressure time integral, total contact area, forefoot rate of load, duration of load as a percentage of stance. Secondary outcomes were patient perceived foot health (Bristol Foot Score), quality of life (Audit of Diabetes Dependent Quality of Life). We also assessed cost of supply and fitting. Analysis was by intention-to-treat.ResultsThere were no differences between insoles in peak pressure, or three of the other four kinetic measures. The custom-made functional insole was slightly more effective than the prefabricated insole in reducing forefoot pressure time integral at issue (27% vs. 22%), remained more effective at six month follow-up (30% vs. 24%, p=0.001), but was more expensive (UK £656 vs. £554, p<0.001). Full compliance (minimum wear 7 hours a day 7 days per week) was reported by 40% of participants and 76% of participants reported a minimum wear of 5 hours a day 5 days per week. There was no difference in patient perception between insoles.ConclusionThe custom-made insoles are more expensive than prefabricated insoles evaluated in this trial and no better in reducing peak pressure. We recommend that where clinically appropriate, the more cost effective prefabricated insole should be considered for use by patients with diabetes and neuropathy.Trial registrationClinical trials.gov (NCT00999635). Note: this trial was registered on completion.

The Physical Characteristics of Materials Used in the Manufacture of Orthoses for Patients with Diabetes

Background: Neuropathic diabetic foot ulceration may be prevented if the mechanical stress transmitted to the plantar tissues can be modified. Orthotic therapy is one practical method commonly used to maintain tissue integrity. Orthotic design must consider the materials chosen for use in fabrication and profile of the device because both aspects influence the performance and durability of the device. Published research evaluating the physical properties of materials commonly used in the manufacture of orthoses for patients with diabetes is limited. This study investigated the physical properties of materials used to fabricate orthoses designed for the prevention of neuropathic diabetic foot ulcers. Methods: Fifteen commonly used orthotic materials were selected for testing: four specifications of 6.4-mm Poron® (Rogers Corp., Gent, Belgium), 3.2-mm Poron®, three densities of 12-mm Ethylene Vinyl Acetate (EVA), 12-mm low-density plastazote, two depths (6.4-mm, 3.2-mm) of Cleron™ (Algeo Ltd., Liverpool, UK), Professional Protective Technology (PPT), and MaxaCane (Algeo Ltd, Liverpool, UK). The density, resilience, stiffness, static coefficient of friction, durability, and compression set of each material were tested, ranked, and allocated a performance indicator score. Results: The most clinically desirable dampening materials tested were Poron® 96 (6-mm) and Poron® 4000 (6-mm). High density EVA (Algeo Ltd., Liverpool, UK) and Lunacell Nora® EVA (Freudenberg, Weinhein, Germany) possessed the properties most suitable to achieve motion control. The data present a simple and useful comparison and classification of the selected materials. Conclusions: Although this information should not be used as a single indicator for assessing the suitability of an orthotic material, the results provide clinically relevant information relating to the physical properties of orthotic materials commonly used in the prevention of neuropathic diabetic foot ulcers.

The relationship between navicular drop and first metatarsophalangeal joint motion.

This study was conducted to determine whether navicular drop, as a representative measure of foot pronation, was associated with first metatarsal joint motion in 24 healthy subjects aged 21 to 40 years. The magnitude of first metatarsophalangeal joint motion was identified using a custom-built weightbearing goniometer designed to measure maximal hallux dorsiflexion in stance. The weightbearing measure of navicular drop was recorded using an adapted digital caliper. Statistical analysis demonstrated a significant negative correlation (P < .05) between the two variables. Furthermore, simple regression analysis suggested that 33.2% of the variation in maximal hallux dorsiflexion could be explained by different navicular drop values.

Effect of Extrinsic Rearfoot Post Design on the Lateral-to-Medial Position and Velocity of the Center of Pressure

Findings from investigations of the effects of external forefoot and rearfoot posts added to foot orthoses have been inconclusive. This study was undertaken to examine the effects of rearfoot post design on the lateral-to-medial position and velocity of the center-of-pressure path. Four identical pairs of neutral-cast polypropylene orthotic shells were constructed; three pairs had a rearfoot post of specified design added. The fourth pair, the control, did not have a post added. Stance period data were broken down into four functional phases, and the statistically significant differences between the experimental conditions were calculated and analyzed. The addition of a rearfoot post to an orthotic shell affects center-of-pressure lateral-to-medial position and velocity. Although the effect of the post designs seemed to provide reasonably predictable changes in center-of-pressure position, the effect on center-of-pressure velocity was variable and inconsistent. The effect of the orthotic post was dependent on design and phase of gait. The addition of a rearfoot post and, specifically, the design of the post can probably be used to alter the center-of-pressure position and velocity.

Patients’ Experience of therapeutic footwear whilst living at risk of neuropathic diabetic foot ulceration: an interpretative phenomenological analysis (IPA)

BackgroundPrevious work has found that people with diabetes do not wear their therapeutic footwear as directed, but the thinking behind this behaviour is unclear. Adherence to therapeutic footwear advice must improve in order to reduce foot ulceration and amputation risk in people with diabetes and neuropathy. Therefore this study aimed to explore the psychological influences and personal experiences behind the daily footwear selection of individuals with diabetes and neuropathy.MethodsAn interpretative phenomenological analysis (IPA) approach was used to explore the understanding and experience of therapeutic footwear use in people living at risk of diabetic neuropathic foot ulceration. This study benefited from the purposive selection of a small sample of four people and used in-depth semi structured interviews because it facilitated the deep and detailed examination of personal thoughts and feelings behind footwear selection.FindingsFour overlapping themes that interact to regulate footwear choice emerged from the analyses: a) Self-perception dilemma; resolving the balance of risk experienced by people with diabetes and neuropathy day to day, between choosing to wear footwear to look and feel normal and choosing footwear to protect their feet from foot ulceration; b) Reflective adaption; The modification and individualisation of a set of values about footwear usage created in the minds of people with diabetes and neuropathy; c) Adherence response; The realignment of footwear choice with personal values, to reinforce the decision not to change behaviour or bring about increased footwear adherence, with or without appearance management; d) Reality appraisal; A here and now appraisal of the personal benefit of footwear choice on emotional and physical wellbeing, with additional consideration to the preservation of therapeutic footwear.ConclusionFor some people living at risk of diabetic neuropathic foot ulceration, the decision whether or not to wear therapeutic footwear is driven by the individual ‘here and now’, risks and benefits, of footwear choice on emotional and physical well-being for a given social context.

A Longitudinal Investigation into the Functional and Physical Durability of Insoles Used for the Preventive Management of Neuropathic Diabetic Feet

BACKGROUND Insoles are commonly used to assist in the prevention of diabetic neuropathic foot ulceration. Insole replacement is often triggered only when foot lesions deteriorate, an indicator that functional performance is comprised and patients are exposed to unnecessary ulcer risk. We investigated the durability of insoles used for ulcer prevention in neuropathic diabetic feet over 12 months. METHODS Sixty neuropathic individuals with diabetes were provided with insoles and footwear. Insole durability over 12 months was evaluated using an in-shoe pressure measurement device and through repeated measurement of material depth at the first metatarsal head and the heel seat. Analysis of variance was performed to assess change across time (at issue, 6 months, and 12 months). RESULTS Analyses were conducted using all available data (n = 43) and compliant data (n = 18). No significant difference was found in the reduction of mean peak pressure tested across time (P < .05). For both sites, significant differences in insole depth were identified between issue and 6 months and between issue and 12 months but not between 6 and 12 months (P < .05). Most insole compression occurred during the initial 6 months. CONCLUSIONS Visual material compression does not seem to be a reliable indicator of insole usefulness. Frequency of insole replacement is best informed by a functional review of effect determined using an in-shoe pressure measurement system. These results suggest that insoles for diabetic neuropathic patients can be effective in maintaining peak pressure reduction for 12 months regardless of wear frequency.

Foot and ankle impairments affect balance and mobility in stroke (FAiMiS): the views and experiences of people with stroke

Abstract Purpose: To explore the nature and impact of foot and ankle impairments on mobility and balance in community-dwelling, chronic stroke survivors. Methods: A qualitative research design using face to face semi-structured, audio recorded interviews. Thirteen community-dwelling stroke survivors, all of whom had self-reported foot and ankle impairments, were interviewed (female n = 6, mean age = 67 years, SD = 12 years, mean time since stroke = 4 years, SD = 6 years, right stroke n = 7, left stroke n = 6). A framework analysis approach was used to analyse and interpret transcribed interviews. Results: Three themes emerged: (1) Impact. The influence of foot and ankle impairments on mobility and balance. (2) Standing out. How participants felt they “stood out” because of their impairments and wanted to be normal. (3) Help. The specific help and advice participants received in managing their problems. Conclusions: Foot and ankle impairments such as pain, altered somatosensory input and weakness significantly contribute to problems with community ambulation, balance and fear of falling in people with chronic stroke. Specific foot and ankle impairments may also negatively contribute to perceptions of physical appearance and self-esteem. Therapeutic management approaches within clinical practice appear to focus mostly on the gross performance of the lower limb with little emphasis on the specific assessment or treatment of the foot or ankle. Implications for Rehabilitation Foot pain, sensory impairments and muscle weakness in the foot and ankle can impact on community ambulation, balance and fear of falling following stroke. Foot and ankle function post-stroke should be routinely assessed and monitored. Clinicians should be aware of the potentially distressing negative perceptions associated with altered gait patterns, footwear and orthotic use.

Effect of a Forefoot Off-loading Postoperative Shoe on Muscle Activity, Posture, and Static Balance

BACKGROUND We investigated whether a forefoot off-loading postoperative shoe (FOPS) alters standing posture, ankle muscle activity, and static postural sway and whether any effects are altered by wearing a shoe raise on the contralateral side. METHODS Posture, ankle muscle activity, and postural sway were compared in 14 healthy participants wearing either a FOPS or a control shoe with or without a contralateral shoe raise. Participants were tested under different sensory and support surface conditions. Additionally, reductions in peak pressure under the forefoot while walking were assessed with and without a contralateral shoe raise to determine whether the FOPS continued to achieve its primary off-loading function. RESULTS Compared with the control condition, wearing a FOPS moved the center of pressure posteriorly, increased tibialis anterior muscle activity, and reduced ankle plantarflexor activity. These changes decreased when a contralateral shoe raise was added. No difference in postural sway was found between footwear conditions. Forefoot peak pressure was always reduced when wearing the FOPS. CONCLUSIONS The posterior shift in center of pressure toward and behind the ankle joint axis is believed to result in the increase in tibialis anterior muscle activity that now acts as the primary stabilizer around the ankle. Instability may, therefore, increase in patients with weak tibialis anterior muscles (eg, diabetic neuropathy) who need to wear offloading devices for ulcer management. We suggest that the addition of a contralateral shoe raise fitted with a FOPS may potentially be beneficial in maintaining stability while off-loading the forefoot in this patient group.

Effects of Foot and Ankle Devices on Balance, Gait and Falls in Adults with Sensory Perception Loss: A Systematic Review

BackgroundFoot and ankle devices are being developed as a method of preventing people with sensory perception loss sustaining a fall. Such devices are believed to work by reducing the likelihood of a fall by improving the balance and gait of the user. ObjectivesThe objective of the review was to evaluate the effectiveness of foot and ankle devices for the prevention of falls and the improvement of balance and gait in adults with sensory perception loss. Inclusion criteria Types of participantsParticipants were community-dwelling adults with bilateral pathological sensory perception loss. Types of intervention(s)/phenomena of interestThe current review evaluated any foot or ankle device, including but not restricted to, all types of footwear (therapeutic and retail), insoles (customized and prefabricated) and ankle-foot orthoses (AFOs). Types of studiesIn the absence of randomized controlled trials (RCT), the review considered experimental and epidemiological study designs, except case series, individual case reports and descriptive cross-sectional studies. OutcomesThe primary outcome was number of falls. Secondary outcome measures were clinical or laboratory measures of balance or gait. Search strategyA search for published and unpublished literature from inception to March 2015 written in the English language was conducted across a number of major electronic databases. A three-step search strategy was developed using MeSH terminology and keywords to ensure all that relevant materials are captured. Methodological qualityMethodological quality of included studies was assessed by two reviewers, who appraised each study independently, using standardized Joanna Briggs Institute (JBI) critical appraisal tools. Data extractionQuantitative data were extracted from the studies that were identified as meeting the criteria for methodological quality using the standardized JBI data extraction tools. Data synthesisDue to the heterogeneity of populations, interventions and outcome measures, meta-analyses were not possible and results are presented in narrative form. ResultsNine trials (from 10 papers) involving 238 participants, (14 with multiple sclerosis and 16 with idiopathic peripheral neuropathy, 150 with diabetic neuropathy) and 58 controls were included in the review. No study reported falls as an outcome measure. The results of the included studies found that in people with sensory perception loss, postural sway improved with vibrating insoles and AFO, altering the softness and texture of the top cover had no effect on postural sway, wearing footwear over long distances or AFOs improved step-to-step consistency, and no foot and ankle device was reported to have a negative effect on the balance or gait of people with sensory perception loss. The methodological quality of the included studies was poor. No study used a randomized controlled trial (RCT) methodology. No study incorporated a follow-up period or tested the intervention within the context of the intended clinical environment. ConclusionThere is limited evidence to suggest that footwear and insole devices can artificially alter postural stability and may reduce the step-to-step variability in adults with sensory perception loss. Varying the material properties of an insole does not notably affect static balance or gait.