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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.)

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

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Ferreira, J. S. S. P. [1] ; Cruvinel Junior, R. H. [1] ; Silva, E. Q. [1] ; Verissimo, J. L. [1] ; Monteiro, R. L. [2, 1] ; Pereira, D. S. [1] ; Suda, E. Y. [1] ; Sartor, C. D. [3] ; Sacco, I. C. N. [1]
Total Authors: 9
[1] Univ Sao Paulo, Dept Phys Therapy Speech & Occupat Therapy, Rua Cipothnea, 51, Cidade Univ, BR-05360160 Sao Paulo, SP - Brazil
[2] Univ Fed Amapa, Dept Phys Therapy, 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 JAN 13 2020.
Web of Science Citations: 0

Background This study is part of a series of two clinical trials. Taking into account the various musculoskeletal alterations of the foot and ankle in people with diabetic peripheral neuropathy (DPN) and the need for self-care to avoid more serious dysfunctions and complications, a self-manageable exercise protocol that focuses on strengthening the foot muscles is presented as a potentially effective preventive method for foot and gait complications. The aim of this trial is to investigate the effect of a customized rehabilitation technology, the Diabetic Foot Guidance System (SOPeD), on DPN status, functional outcomes and gait biomechanics in people with DPN. Methods/design Footcare (FOCA) trial I is a randomized, controlled and parallel two-arm trial with blind assessment. A total of 62 patients with DPN will be allocated into either a control group (recommended foot care by international consensus with no foot exercises) or an intervention group (who will perform exercises through SOPeD at home three times a week for 12 weeks). The exercise program will be customized throughout its course by a perceived effort scale reported by the participant after completion of each exercise. The participants will be assessed at three different times (baseline, completion at 12 weeks, and follow-up at 24 weeks) for all outcomes. The primary outcomes will be DPN symptoms and severity classification. The secondary outcomes will be foot-ankle kinematics and kinetic and plantar pressure distribution during gait, tactile and vibration sensitivities, foot health and functionality, foot strength, and functional balance. Discussion As there is no evidence about the efficacy of rehabilitation technology in reducing DPN symptoms and severity or improving biomechanical, clinical, and functional outcomes for people with DPN, this research can contribute substantially to clarifying the therapeutic merits of software interventions. We hope that the use of our application for people with DPN complications will reduce or attenuate the deficits caused by DPN. This rehabilitation technology is freely available, and we intend to introduce it into the public health system in Brazil after demonstrating its effectiveness. (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: 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: 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: 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