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

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dc.contributorSistema FMUSP-HC: Faculdade de Medicina da Universidade de São Paulo (FMUSP) e Hospital das Clínicas da FMUSP
dc.contributor.authorSILVA, E. Q.
dc.contributor.authorSUDA, E. Y.
dc.contributor.authorSANTOS, D. P.
dc.contributor.authorVERISSIMO, J. L.
dc.contributor.authorFERREIRA, J. S. S. P.
dc.contributor.authorCRUVINEL JUNIOR, R. H.
dc.contributor.authorMONTEIRO, R. L.
dc.contributor.authorSARTOR, C. D.
dc.contributor.authorSACCO, I. C. N.
dc.date.accessioned2020-06-01T14:52:22Z
dc.date.available2020-06-01T14:52:22Z
dc.date.issued2020
dc.description.abstractBackground This study is a part of a series of two clinical trials. We consider diabetic polyneuropathy (DPN), a common chronic and progressive complication of diabetes mellitus that has several impacts on individuals' 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. Methods/design 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 weeks) group. Participants from both groups will be assessed at baseline, after 8 weeks, and at 16 weeks for follow-up. The primary outcomes are the DPN symptoms and severity, and the secondary outcomes are foot-ankle kinematics, gait kinetics, plantar pressure distribution during gait, tactile and vibratory sensitivities, foot strength, functional balance, and foot health and functionality. Discussion 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-ankle 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.eng
dc.description.indexMEDLINEeng
dc.description.sponsorshipNational Council for Scientific and Technological Development, Brazil (CNPq)National Council for Scientific and Technological Development (CNPq) [407252/2018-5]
dc.description.sponsorshipAgency Coordination of Improvement of Higher Education Personnel (CAPES) [001]
dc.description.sponsorshipSao Paulo Research Agency (FAPESP) [2017/15449-4, 2019/02624-8, 2019/02522-0, 2019/06405-9, 2017/17848-3]
dc.identifier.citationTRIALS, v.21, n.1, article ID 180, 13p, 2020
dc.identifier.doi10.1186/s13063-020-4115-8
dc.identifier.eissn1745-6215
dc.identifier.urihttps://observatorio.fm.usp.br/handle/OPI/35932
dc.language.isoeng
dc.publisherBMCeng
dc.relation.ispartofTrials
dc.rightsopenAccesseng
dc.rights.holderCopyright BMCeng
dc.subjectDiabetic neuropathieseng
dc.subjectExerciseeng
dc.subjectPreventive careeng
dc.subjectDiabetic footeng
dc.subjectFoot ulcereng
dc.subjectClinical trialeng
dc.subjectPhysical therapyeng
dc.subject.otherlimited joint mobilityeng
dc.subject.otherplantar pressureseng
dc.subject.otherperipheral neuropathyeng
dc.subject.othermuscle strengtheng
dc.subject.otherhigh-riskeng
dc.subject.othertherapyeng
dc.subject.otherwalkingeng
dc.subject.otherulcerseng
dc.subject.otherkinematicseng
dc.subject.otherexerciseeng
dc.subject.wosMedicine, Research & Experimentaleng
dc.titleEffect 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 trialeng
dc.typearticleeng
dc.type.categoryoriginal articleeng
dc.type.versionpublishedVersioneng
dspace.entity.typePublication
hcfmusp.author.externalSANTOS, D. P.:Univ Sao Paulo, Sch Med, Dept Phys Therapy Speech & Occupat Therapy, Rua Cipotanea 51,Cidade Univ, BR-05360160 Sao Paulo, SP, Brazil
hcfmusp.author.externalMONTEIRO, R. L.:Univ Sao Paulo, Sch Med, Dept Phys Therapy Speech & Occupat Therapy, Rua Cipotanea 51,Cidade Univ, BR-05360160 Sao Paulo, SP, Brazil; Univ Fed Amapa, Dept Phys Therapy, Macapa, Amapa, Brazil
hcfmusp.author.externalSARTOR, C. D.:Univ Ibirapuera, Dept Phys Therapy, Sao Paulo, SP, Brazil
hcfmusp.citation.scopus9
hcfmusp.contributor.author-fmusphcERICA QUEIROZ DA SILVA
hcfmusp.contributor.author-fmusphcENEIDA YURI SUDA
hcfmusp.contributor.author-fmusphcJADY LUARA VERISSIMO
hcfmusp.contributor.author-fmusphcJANE SUELEN SILVA PIRES FERREIRA
hcfmusp.contributor.author-fmusphcRONALDO HENRIQUE CRUVINEL JUNIOR
hcfmusp.contributor.author-fmusphcISABEL DE CAMARGO NEVES SACCO
hcfmusp.description.articlenumber180
hcfmusp.description.issue1
hcfmusp.description.volume21
hcfmusp.origemWOS
hcfmusp.origem.pubmed32054510
hcfmusp.origem.scopus2-s2.0-85079334519
hcfmusp.origem.wosWOS:000515885900001
hcfmusp.publisher.cityLONDONeng
hcfmusp.publisher.countryENGLANDeng
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