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

Autor(es)

Silva, E. Q. ^[1] ; Suda, E. Y. ^[1] ; Santos, D. P. ^[1] ; Verissimo, J. L. ^[1] ; Ferreira, J. S. S. P. ^[1] ; Cruvinel Junior, R. H. ^[1] ; Monteiro, R. L. ^{[1, 2]} ; Sartor, C. D. ^[3] ; Sacco, I. C. N. ^[1]

Afiliação do(s) autor(es)

^[1] Univ Sao Paulo, Sch Med, Dept Phys Therapy Speech & Occupat Therapy, Rua Cipotanea 51, Cidade Univ, BR-05360160 Sao Paulo, SP - Brazil

^[2] Univ Fed Amapa, Dept Phys Therapy, Macapa, Amapa - Brazil

^[3] Univ Ibirapuera, Dept Phys Therapy, Sao Paulo, SP - Brazil

• Tipo de documento: Artigo Científico
• Fonte: Trials; v. 21, n. 1 FEB 13 2020.
• Citações Web of Science: 0

Resumo

Background 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. (AU)

• Processo FAPESP: 19/02624-8 - Efeito do uso de uma ferramenta de tecnologia de reabilitação para o autocuidado, prevenção e tratamento dos pés de pessoas com diabetes mellitus: ensaio clínico randomizado controlado
• Beneficiário: Danilo Pereira dos Santos
• Modalidade de apoio: Bolsas no Brasil - Iniciação Científica
• Processo FAPESP: 19/06405-9 - Tecnologia de reabilitação para prevenção de disfunções musculoesqueléticas e tratamento dos pés de pessoas com diabetes mellitus: estudo FOotCAre (FOCA) prova de conceito
• Beneficiário: Ronaldo Henrique Cruvinel Júnior
• Modalidade de apoio: Bolsas no Brasil - Mestrado
• Processo FAPESP: 17/15449-4 - Biomecânica e aspectos funcionais do sistema musculoesquelético de corredores: efeito crônico de exercícios terapêuticos e do envelhecimento
• Beneficiário: Eneida Yuri Suda
• Modalidade de apoio: Bolsas no Brasil - Pós-Doutorado
• Processo FAPESP: 17/17848-3 - Efeitos do fortalecimento dos músculos dos pés na atividade física de vida diária e funcionalidade de tornozelo e pé de pessoas com polineuropatia diabética: um ensaio clínico controlado randomizado
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• Modalidade de apoio: Bolsas no Brasil - Doutorado
• Processo FAPESP: 19/02522-0 - Tecnologia de reabilitação para prevenção de disfunções musculoesqueléticas e dos pés de pessoas com Diabetes Mellitus: ensaio FootCAre (FoCa) preventivo controlado randomizado
• Beneficiário: Jane Suelen Silva Pires Ferreira
• Modalidade de apoio: Bolsas no Brasil - Doutorado