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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

Grant number: 19/02624-8
Support Opportunities:Scholarships in Brazil - Scientific Initiation
Effective date (Start): June 01, 2019
Effective date (End): January 31, 2020
Field of knowledge:Health Sciences - Physiotherapy and Occupational Therapy
Principal Investigator:Isabel de Camargo Neves Sacco
Grantee:Danilo Pereira dos Santos
Host Institution: Faculdade de Medicina (FM). Universidade de São Paulo (USP). São Paulo , SP, Brazil


Peripheral diabetic polyneuropathy (DPN) is one of the main complications of diabetes, which causes changes in sensitivity (thermal, tactile, vibratory and proprioceptive) and motor alterations associated with foot deformities. Such complications, when aggravated, can favor the appearance of wounds that, when untreated, usually develop into ulcers and end with limb amputation. The changes resulting from DPN can be attenuated through specific exercise programs for the feet, thus leading to improvements for muscle function and daily living functionality. The various musculoskeletal changes in the foot-ankle in people with DPN requires self-care, so foot exercises, in which the person can self-manage, may be effective in preventing foot complications resulting from DPN. This randomized controlled clinical trial aims to evaluate the use of a rehabilitation technology in a booklet format and the effects on the clinical responses of DPN (tactile and vibratory sensitivity, functional balance and foot function). The sample will be composed of 38 patients with DPN of up to 75 years who will be allocated randomly in the control (CG) or intervention (GI) groups. The subjects will be evaluated in 2 moments, before the beginning of the intervention and after 8 weeks. The assessment includes foot health and functionality, tactile and vibratory foot sensitivity, and functional balance. The hypothesis of this study is that the intervention group will improve the health and functionality of the feet and DPN symptoms, increase the tactile and vibratory sensitivity and improve the functional balance, when compared to the control group after 8 weeks of intervention.

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Scientific publications
(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)
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)
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)
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)

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