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(Reference retrieved automatically from Web of Science through information on FAPESP grant and its corresponding number as mentioned in the publication by the authors.)

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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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]
Total Authors: 9
[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
Total Affiliations: 3
Document type: Journal article
Source: Trials; v. 21, n. 1 FEB 13 2020.
Web of Science Citations: 0

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)

FAPESP's process: 19/02624-8 - Effect of the use of a rehabilitation technology tool for self-care, prevention and treatment of the foot of people with diabetes mellitus: randomized controlled trial
Grantee:Danilo Pereira dos Santos
Support Opportunities: Scholarships in Brazil - Scientific Initiation
FAPESP's process: 19/06405-9 - Rehabilitation technology for prevention of musculoskeletal dysfunctions and treatment of people's feet with diabetes mellitus: study FOotCAre (FOCA) proof of concept
Grantee:Ronaldo Henrique Cruvinel Júnior
Support Opportunities: Scholarships in Brazil - Master
FAPESP's process: 17/15449-4 - Biomechanical and functional aspects of the musculoskeletal system of runners: chronic effects of therapeutic exercise and aging
Grantee:Eneida Yuri Suda
Support Opportunities: Scholarships in Brazil - Post-Doctoral
FAPESP's process: 17/17848-3 - Effects of foot muscle strengthening in daily activity and functionality of foot and ankle in diabetic polyneuropathy patients: a randomized controlled trial
Grantee:Renan Lima Monteiro
Support Opportunities: Scholarships in Brazil - Doctorate
FAPESP's process: 19/02522-0 - Rehabilitation technology for prevention of musculoskeletal and foot dysfunctions of people with Diabetes Mellitus: FootCAre (FoCa) prevention randomized controlled trial
Grantee:Jane Suelen Silva Pires Ferreira
Support Opportunities: Scholarships in Brazil - Doctorate