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

Autor: Érica Q. Silva, Isabel C. N. Sacco, Jane S. S. P. Ferreira, Danilo Pereira dos Santos, Renan L. Monteiro, R. H. Cruvinel Junior, Eneida Yuri Suda, Cristina D. Sartor, Jady L. Verissímo
Jazyk: angličtina
Rok vydání: 2020
Předmět:
Male
Diabetic neuropathy
Medicine (miscellaneous)
Severity of Illness Index
law.invention
Study Protocol
0302 clinical medicine
Randomized controlled trial
law
Activities of Daily Living
Medicine
Pharmacology (medical)
Single-Blind Method
Randomized Controlled Trials as Topic
lcsh:R5-920
Middle Aged
Clinical trial
Diabetic foot
Treatment Outcome
Female
lcsh:Medicine (General)
Foot (unit)
Diabetic neuropathies
Adult
medicine.medical_specialty
Preventive care
Adolescent
030209 endocrinology & metabolism
03 medical and health sciences
Young Adult
Quality of life (healthcare)
Patient Education as Topic
Diabetes mellitus
Humans
Muscle Strength
Muscle
Skeletal
Exercise
Aged
Foot ulcer
business.industry
Foot
medicine.disease
Gait
Self Care
Diabetes Mellitus
Type 2
Physical therapy
Quality of Life
Pamphlets
business
030217 neurology & neurosurgery
Follow-Up Studies
Zdroj: Trials, Vol 21, Iss 1, Pp 1-13 (2020)
Trials
ISSN: 1745-6215
Popis: 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. Trial registration ClinicalTrials.gov, NCT04008745. Registered on 2 July 2019.
Databáze: OpenAIRE
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