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

Autor: D. S. Pereira, Jady L. Verissímo, Eneida Yuri Suda, Isabel C. N. Sacco, Cristina D. Sartor, Renan L. Monteiro, R. H. Cruvinel Junior, Érica Q. Silva, Jane S. S. P. Ferreira
Jazyk: angličtina
Rok vydání: 2020
Předmět:
Male
Time Factors
Diabetic neuropathy
medicine.medical_treatment
Rehabilitation technology
Psychological intervention
Medicine (miscellaneous)
law.invention
Study Protocol
0302 clinical medicine
Diabetic Neuropathies
Randomized controlled trial
law
Medicine
Single-Blind Method
Pharmacology (medical)
030212 general & internal medicine
Gait
lcsh:R5-920
Rehabilitation
Middle Aged
Biomechanical Phenomena
Exercise Therapy
Diabetic foot
Treatment Outcome
Female
lcsh:Medicine (General)
Brazil
Foot (unit)
Adult
medicine.medical_specialty
Preventive care
Adolescent
030209 endocrinology & metabolism
Equivalence Trials as Topic
Young Adult
03 medical and health sciences
Physical medicine and rehabilitation
Self-management
Humans
Muscle Strength
Aged
Foot-related exercises
Foot
business.industry
medicine.disease
Self Care
Clinical trial
eHealth
Musculoskeletal function
business
Zdroj: Trials, Vol 21, Iss 1, Pp 1-14 (2020)
Trials
ISSN: 1745-6215
Popis: BackgroundThis 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/designFootcare (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.DiscussionAs 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.Trial registrationClinicalTrials.gov,NCT04011267. Registered on 8 July 2019.
Databáze: OpenAIRE
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