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Rehabilitation technology for prevention of musculoskeletal and foot dysfunctions of people with Diabetes Mellitus: FootCAre (FoCa) prevention randomized controlled trial

Grant number: 19/02522-0
Support Opportunities:Scholarships in Brazil - Doctorate
Effective date (Start): November 01, 2019
Effective date (End): October 31, 2023
Field of knowledge:Health Sciences - Physiotherapy and Occupational Therapy
Principal Investigator:Isabel de Camargo Neves Sacco
Grantee:Jane Suelen Silva Pires Ferreira
Host Institution: Faculdade de Medicina (FM). Universidade de São Paulo (USP). São Paulo , SP, Brazil

Abstract

Considering the several alterations on the feet and ankles present in patients with Diabetic Polyneuropathy (DPN) and the need for self-care in order to avoid more serious complications such as ulcer and amputation, the inclusion of a protocol to strengthen the musculature of the feet, in which the patient can self-manage can be presented as an efficient method, since such exercises aim at specifically strengthening the PND compromised muscles. The project will be a health technology assessment to investigate the safety, effectiveness and adherence of the use of a rehabilitation technology (software sistema de orientação ao pé diabético that customizes a protocol of therapeutic exercises for the foot and ankle of individuals with diabetes) and the effects of the use of such technology on the clinical responses of DPN (tactile and vibration sensitivities, functional balance and foot functionality) and gait biomechanics. To access the effectiveness of the software, it will be designed a parallel controlled independent controlled preventive trial with random allocation and blinding of the evaluators for prevention and Foot Care (FOCA trial). The sample will be composed of 62 patients with DPN of up to 65 years who will be randomly divided into the control or intervention groups. The subjects will be assessed in 3 moments. The assessment includes gait kinematic and kinetics and plantar pressure distribution during gait, DPN symptoms, severity of neuropathy and foot muscle strength. The hypothesis of this study is that the intervention group will improve the neuropathic symptoms, reduce the severity of the neuropathy, improve sensitivity modalities, functional balance and functionality of the feet, when compared to the control group after 12 weeks of intervention, moreover, that adherence to the use of self-care tools will be equal to or greater than 80% and that the technology will represent greater viability with respect to quality of life. (AU)

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Scientific publications (10)
(References retrieved automatically from Web of Science and SciELO through information on FAPESP grants and their corresponding numbers as mentioned in the publications by the authors)
FERREIRA, J. S. S. P.; CRUVINEL JUNIOR, R. H.; SILVA, E. Q.; VERISSIMO, J. L.; MONTEIRO, R. L.; PEREIRA, D. S.; SUDA, E. Y.; SARTOR, C. D.; SACCO, I. C. N.. Study protocol for a randomized controlled trial on the effect of the Diabetic Foot Guidance System (SOPeD) for the prevention and treatment of foot musculoskeletal dysfunctions in people with diabetic neuropathy: the FOotCAre (FOCA) trial I. Trials, v. 21, n. 1, . (19/02624-8, 17/17848-3, 17/15449-4, 19/02522-0)
FERREIRA, JANE S. S. P.; PANIGHEL, JOAO P.; SILVA, ERICA Q.; MONTEIRO, RENAN L.; CRUVINEL JUNIOR, RONALDO H.; SACCO, ISABEL C. N.. Foot function and strength of patients with diabetes grouped by ulcer risk classification (IWGDF). DIABETOLOGY & METABOLIC SYNDROME, v. 11, n. 1, . (19/02522-0)
SILVA, E. Q.; SUDA, E. Y.; SANTOS, D. P.; VERISSIMO, J. L.; FERREIRA, J. S. S. P.; CRUVINEL JUNIOR, R. H.; MONTEIRO, R. L.; SARTOR, C. D.; SACCO, I. C. N.. 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. Trials, v. 21, n. 1, . (19/02624-8, 19/06405-9, 17/15449-4, 17/17848-3, 19/02522-0)
CRUVINEL JUNIOR, RONALDO H.; FERREIRA, JANE S. S. P.; BETELI, I, RAQUEL; SILVA, ERICA Q.; VERISSIMO, JADY L.; MONTEIRO, RENAN L.; SUDA, ENEIDA Y.; SACCO, ISABEL C. N.. Foot-ankle functional outcomes of using the Diabetic Foot Guidance System (SOPeD) for people with diabetic neuropathy: a feasibility study for the single-blind randomized controlled FOotCAre (FOCA) trial I. PILOT AND FEASIBILITY STUDIES, v. 7, n. 1, . (17/15449-4, 19/06405-9, 19/02522-0, 17/17848-3)
MONTEIRO, RENAN L.; FERREIRA, JANE S. S. P.; SILVA, ERICA Q.; DONINI, ASHA; CRUVINEL-JUNIOR, RONALDO H.; VERISSIMO, JADY L.; BUS, SICCO A.; SACCO, ISABEL C. N.. Feasibility and Preliminary Efficacy of a Foot-Ankle Exercise Program Aiming to Improve Foot-Ankle Functionality and Gait Biomechanics in People with Diabetic Neuropathy: A Randomized Controlled Trial. SENSORS, v. 20, n. 18, p. 18-pg., . (19/06405-9, 17/17848-3, 19/02522-0)
SILVA, ERICA Q.; SANTOS, DANILO P.; BETELI, RAQUEL I.; MONTEIRO, RENAN L.; FERREIRA, JANE S. S. P.; CRUVINEL-JUNIOR, RONALDO H.; DONINI, ASHA; VERISSIMO, JADY L.; SUDA, ENEIDA Y.; SACCO, ISABEL C. N.. Feasibility of a home-based foot-ankle exercise programme for musculoskeletal dysfunctions in people with diabetes: randomised controlled FOotCAre (FOCA) Trial II. SCIENTIFIC REPORTS, v. 11, n. 1, . (19/02624-8, 17/15449-4, 19/02522-0, 17/17848-3, 19/06405-9)
MONTEIRO, RENAN L.; FERREIRA, JANE S. S. P.; SILVA, ERICA Q.; CRUVINEL, RONALDO H.; VERISSIMO, JADY L.; BUS, SICCO A.; SACCO, ISABEL C. N.. Effects of foot-ankle exercises on foot-ankle kinematics, plantar pressure, and gait kinetics in people with diabetic neuropathy: Secondary outcomes from a randomized controlled trial. BRAZILIAN JOURNAL OF PHYSICAL THERAPY, v. 27, n. 3, p. 11-pg., . (19/02522-0, 21/00807-8, 17/17848-3)
SILVA, ERICA Q.; VERISSIMO, JADY L.; FERREIRA, JANE S. S. P.; CRUVINEL-JUNIOR, RONALDO H.; MONTEIRO, RENAN L.; SUDA, ENEIDA Y.; SACCO, ISABEL C. N.. Effects of a Home-Based Foot-Ankle Exercise Program with Educational Booklet for Foot Dysfunctions in People with Diabetic Neuropathy: Results of the FOCA-II Randomized Controlled Clinical Trial. APPLIED SCIENCES-BASEL, v. 13, n. 3, p. 15-pg., . (19/02522-0, 21/00807-8, 17/17848-3)
CRUVINEL-JUNIOR, RONALDO H. H.; FERREIRA, JANE S. S. P.; VERISSIMO, JADY L.; MONTEIRO, RENAN L. L.; SUDA, ENEIDA Y. Y.; SILVA, ERICA Q.; SACCO, ISABEL C. N.. Could an Internet-Based Foot-Ankle Therapeutic Exercise Program Modify Clinical Outcomes and Gait Biomechanics in People with Diabetic Neuropathy? A Clinical Proof-of-Concept Study. SENSORS, v. 22, n. 24, p. 17-pg., . (19/02522-0, 21/00807-8, 17/17848-3, 17/15449-4)
MONTEIRO, RENAN L.; FERREIRA, JANE S. S. P.; SILVA, ERICA Q.; CRUVINEL-JUNIOR, RONALDO H.; VERISSIMO, JADY L.; BUS, SICCO A.; SACCO, ISABEL C. N.. Foot-ankle therapeutic exercise program can improve gait speed in people with diabetic neuropathy: a randomized controlled trial. SCIENTIFIC REPORTS, v. 12, n. 1, p. 12-pg., . (17/17848-3, 19/06405-9, 19/02522-0)

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