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We consider diabetic polyneuropathy (DPN), a common chronic and progressive complication of diabetes mellitus that has several impacts on individuals\u2019 foot health and quality of life. Based on the current trends of self-monitoring and self-care, providing a tool with foot-related exercises and educational care may help patients to avoid or reduce the musculoskeletal complications resulting from DPN, improving autonomous performance in daily living tasks. The aim of this trial is to evaluate the effects of an educational booklet for foot care and foot muscle strengthening on DPN symptoms and severity, clinical outcomes, and gait biomechanics in patients with DPN.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods\/design<\/jats:title>\n                    <jats:p>The FOotCAre (FOCA) trial II study has been designed as a single-blind, two-parallel-arm randomized controlled trial. It will include 48 patients with DPN who will be randomly allocated to a control (recommended foot care by international consensus with no foot exercises) group or an intervention (foot-related exercises using an educational booklet three times\/week at home for 8\u2009weeks) group. Participants from both groups will be assessed at baseline, after 8\u2009weeks, and at 16\u2009weeks for follow-up. The primary outcomes are the DPN symptoms and severity, and the secondary outcomes are foot\u2013ankle kinematics, gait kinetics, plantar pressure distribution during gait, tactile and vibratory sensitivities, foot strength, functional balance, and foot health and functionality.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion<\/jats:title>\n                    <jats:p>The booklet is a management tool that allows users to be autonomous in their treatment by choosing how and where to perform the exercises. This allows the patients to perform the exercises regularly as a continuous habit for foot care and health, which is an important element in the management of the diabetic foot. As the booklet focuses on specific foot\u2013ankle exercises, we expect that it will improve the clinical aspects of DPN and produce beneficial biomechanical changes during gait, becoming a powerful self-management tool that can be easily implemented to improve the performance of daily living tasks.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>\n                      ClinicalTrials.gov,\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04008745?term=booklet&amp;cond=Diabetes\">NCT04008745<\/jats:ext-link>\n                      . Registered on 2 July 2019.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s13063-020-4115-8","type":"journal-article","created":{"date-parts":[[2020,2,13]],"date-time":"2020-02-13T09:02:47Z","timestamp":1581584567000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":13,"title":["Effect of an educational booklet for prevention and treatment of foot musculoskeletal dysfunctions in people with diabetic neuropathy: the FOotCAre (FOCA) trial II, a study protocol of a randomized controlled trial"],"prefix":"10.1186","volume":"21","author":[{"given":"E. Q.","family":"Silva","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"E. Y.","family":"Suda","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"D. 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The trial was registered at ClinicalTrials.gov (a service of the US National Institutes of Health) with identifier NCT04008745 (2 July 2019) under the brief title \u201c Effect of Educational Booklet for Foot-related Exercises for Prevention and Treatment in People with Diabetic Neuropathy (FOCA-II)\u201d<i>.<\/i> The main researcher will explain to each eligible participant every step of the assessment and follow-up, the possible risks, and the fact that no compensations or benefits are to be expected. When agreeing to participate, participants will be asked for written informed consent, according to the standard forms.On the consent form, participants will be asked if they agree to use their data in the study; if they do not agree, they can choose to withdraw from the trial. Participants will also be asked for permission for the research team to share relevant data with people from the University taking part in the research or from regulatory authorities, where relevant.Any changes made to the protocol will be amended and communicated via a report sent to the sponsor and funder. The ethics committee will also be notified by submission of a form via the national website of the research ethics committee,\n                      \n                      . Changes will also be included in the clinical trial register (\n                      \n                      ).This trial does not involve collecting biological specimens for storage<u>.<\/u>","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare that they have no competing interests.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"180"}}