11 research outputs found

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

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    UNLABELLED: BACKGROUND: Neuropathic 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. METHOD: A 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. RESULTS: There 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. CONCLUSION: The 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 REGISTRATION: Clinical trials.gov (NCT00999635). Note: this trial was registered on completion

    Heel raises versus prefabricated orthoses in the treatment of posterior heel pain associated with calcaneal apophysitis (Sever's Disease): study protocol for a randomised controlled trial

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    <p>Abstract</p> <p>Background</p> <p>Posterior Heel pain can present in children of 8 to 14 years, associated with or clinically diagnosed as Sever's disease, or calcaneal apophysitis. Presently, there are no comparative randomised studies evaluating treatment options for posterior heel pain in children with the clinical diagnosis of calcaneal apophysitis or Sever's disease. This study seeks to compare the clinical efficacy of some currently employed treatment options for the relief of disability and pain associated with posterior heel pain in children.</p> <p>Method</p> <p>Design: Factorial 2 × 2 randomised controlled trial with monthly follow-up for 3 months.</p> <p>Participants: Children with clinically diagnosed posterior heel pain possibly associated with calcaneal apophysitis/Sever's disease (n = 124).</p> <p>Interventions: Treatment factor 1 will be two types of shoe orthoses: a heel raise or prefabricated orthoses. Both of these interventions are widely available, mutually exclusive treatment approaches that are relatively low in cost. Treatment factor 2 will be a footwear prescription/replacement intervention involving a shoe with a firm heel counter, dual density EVA midsole and rear foot control. The alternate condition in this factor is no footwear prescription/replacement, with the participant wearing their current footwear.</p> <p>Outcomes: Oxford Foot and Ankle Questionnaire and the Faces pain scale.</p> <p>Discussion</p> <p>This will be a randomised trial to compare the efficacy of various treatment options for posterior heel pain in children that may be associated with calcaneal apophysitis also known as Sever's disease.</p> <p>Trial Registration</p> <p>Trial Number: ACTRN12609000696291</p> <p>Ethics Approval Southern Health: HREC Ref: 09271B</p

    Validity and reliability of a new ankle dorsiflexion measurement device

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    Background: The assessment of the maximum ankle dorsiflexion angle is an important clinical examination procedure. Evidence shows that the traditional goniometer is highly unreliable, and various designs of goniometers to measure the maximum ankle dorsiflexion angle rely on the application of a known force to obtain reliable results. Hence, an innovative ankle dorsiflexion measurement device was designed to make this measurement more reliable by holding the foot in a selected posture without the application of a known moment. Objectives: To report on the comprehensive validity and reliability testing carried out on the new device. Methods: Following validity testing, four different trials to test reliability of the ankle dorsiflexion measurement device were performed. These trials included inter-rater and intra-rater testings with a controlled moment, intra-rater reliability testing with knees flexed and extended without a controlled moment, intra-rater testing with a patient population, and inter-rater reliability testing between four raters of varying experience without controlling moment. All raters were blinded. Study Design: A series of trials to test intra-rater and inter-rater reliabilities. Results: Intra-rater reliability intraclass correlation coefficient was 0.98 and inter-rater reliability intraclass correlation coefficient (2,1) was 0.953 with a controlled moment. With uncontrolled moment, very high reliability for intra-tester was also achieved (intraclass correlation coefficient = 0.94 with knees extended and intraclass correlation coefficient = 0.95 with knees flexed). For the trial investigating test–retest reliability with actual patients, intraclass correlation coefficient of 0.99 was obtained. In the trial investigating four different raters with uncontrolled moment, intraclass correlation coefficient of 0.91 was achieved. Conclusions: The new ankle dorsiflexion measurement device is a valid and reliable device for measuring ankle dorsiflexion in both healthy subjects and patients, with both controlled and uncontrolled moments, even by multiple raters of varying experience when the foot is dorsiflexed to its end of range of motion. Clinical relevance An ankle dorsiflexion measuring device has been designed to increase the reliability of ankle dorsiflexion measurement and replace the traditional goniometer. While the majority of similar devices rely on application of a known moment to perform this measurement, it has been shown that this is not required with the new ankle dorsiflexion measurement device and, rather, foot posture should be taken into consideration as this affects the maximum ankle dorsiflexion angle

    A Clinical Approach to Diagnose Flatfoot Deformity

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